Catheterization and Cardiovascular Interventions 73:350–360 (2009)

Basic Science

A Comparison of the Mechanical Performance

Characteristics of Seven Drug-Eluting Stent Systems
W. Schmidt,1* DR-ING, P. Lanzer,2 MD, P. Behrens,1 DIPL-ING, L.D.T. Topoleski,3 PhD,
and K.-P. Schmitz,1 DR.-ING
Objectives: Mechanical properties of drug eluting stents (DES) will be measured to pro-
vide comparable numerical data to assess deliverability, and thus clinical performance.
Background: DES are routinely used in coronary interventions to reduce the rates of
restenosis and target vessel revascularizations. Current research is primarily con-
cerned with issues related to late stent thrombosis. However, mechanical properties of
DES are a critical determinant of deliverability, and consequently the ultimate arbiter of
their clinical performance. Methods: Mechanical properties (pushability, trackability,
crossability) were measured under standardized in-vitro conditions. The vessel models
were derived from typical vessel anatomy but adapted to the individual tests. Addition-
ally, profile and bending forces of the stent segment of the delivery system were meas-
ured. Seven different commercially available balloon-expandable coronary DES sys-
tems were included. All stents were 3.0 mm diameter with a stent length from 14 to 18
mm. Results: The pushability expressed as the ratio of distal force at a specific proxi-
mal push force (4N) ranged between 38.66 and 18.53%. The trackability as the mean
track-forces ranged from 0.551 N to 1.137 N. One stent system could not pass this
test. The mean crossing forces at a 1.4 mm stenosis model ranged from 0.038 N up to
0.103 N. The mean crimped stent profiles ranged from 1.055 mm to 1.198 mm and the
bending stiffness of the crimped stent was 17.22 to 47.20 Nmm2. Conclusion: Better
understanding of mechanical properties of DES shall improve tactile skills of the inter-
ventionists during PCI and to improve criteria for DES selection in specific clinical set-
tings. ' 2008 Wiley-Liss, Inc.

Key words: invasive cardiology; drug-eluting stents; mechanical performance; clinical

impact

INTRODUCTION
Drug-eluting stents (DES) are routinely used in cor-
onary interventions to reduce the rates of restenosis
and target vessel revascularizations [1–3]. Current
research is concerned primarily with safety issues
related to late stent thrombosis [4–6]. However, the
mechanical properties of DES are a critical determi-
nant of deliverability and therefore the ultimate arbiter
of their clinical utility. It is essential for the clinician
to know and understand the differences in model-spe-
cific DES behavior for optimum clinical results. Never-
theless, surprisingly little data is available on this im-
portant topic.
The mechanical response of coronary stent systems
and other endovascular devices has been described
using terms such as pushability, trackability, crossabil-
1
Institute for Biomedical Engineering, University of Rostock,
Rostock, Germany
2
Department for Cardiology and Angiology, Hospitals and Clin-
ics Bitterfeld/Wolfen, Bitterfeld, Germany
3
Department of Mechanical Engineering, University of Mary-
land, Baltimore County, Baltimore, Maryland
Conflict of interest: Nothing to report.
*Correspondence to: Wolfram Schmidt, DR-ING, Institute for Bio-
medical Engineering, University of Rostock, Ernst-Heydemann-
Straße 6, 18055 Rostock, Germany. E-mail: wolfram.schmidt@uni-
rostock.de
Received 8 April 2008; Revision accepted 5 September 2008
DOI 10.1002/ccd.21832
Published online 9 December 2008 in Wiley InterScience (www.
interscience.wiley.com).

' 2008 Wiley-Liss, Inc.

 Mechanical Performance of Drug-Eluting Stent Systems
Fig. 1. 3D structure of the crimped stents. 1: Biosensors Biomatrix; 2: Conor CoStar; 3: Cor-
dis Cypher select 1; 4: Medtronic Endeavor; 5: Boston Scientific Taxus Liberté; 6: Guidant
Xience V; 7: B. Braun Coroflex Please.
ity, flexibility, conformability, and torque control [7–
16]; yet, their definitions have remained vague or
inconsistent.
To characterize the mechanical responses of DES,
we have defined pushability, trackablity, and crossabil-
ity by objective measurements of the externally applied
force and the resulting force measured at the catheter
tip and the relations between them. We conducted
these measurements under well-established, standar-
dized, and validated in vitro experimental conditions.
In addition, diameter and bending forces required to
deform the stent segment of the delivery system were
measured. The mechanical performances of seven com-
mercially available DES systems were studied.
MATERIALS AND METHODS
Measurements were performed on seven different
commercially available balloon-expandable coronary
DES systems (see Fig. 1). To allow comparisons, all
stents were 3.0-mm design diameter with the stent
length ranging from 14 to 18 mm depending on the
manufacturer’s specifications. For each DES brand,
one randomly selected specimen was studied.
To perform the measurements, each DES was
removed from the original wrapping and introduced
into a guiding catheter (Cordis Vista brite tip 6F
JL3.5, I.D. 0.067@) over a 0.014@ guide wire (Guidant
HI-Torque Balance MiddleWeight 0.014@) to complete
the interventional system. Neither the guiding catheter
nor the guide wire was changed during testing to
ensure a constant test environment. Prior validation
testing showed that there is good reproducibility [10],
in particular no measurable change in physical proper-
ties due to abrasion or contamination processes.
Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
351
All measurements were performed in a 378C heated
water basin at a travel speed of 7.5 mm/s delivered by
a guide (maximum travel distance 500 mm, Cleveland
Präzisionssysteme GmbH, Germany), which is driven
by a DC servo motor (type tendo PM 41, Chr. Mayr
GmbH, Germany). The details of tubing material and
dimensions are given in the following sections and fig-
ures. The guiding catheter and the vessel model were
flushed prior to each testing series. The vessel models
were derived from typical vessel anatomy but adapted
to the individual tests.
All measurements were performed on a single stent
system of each DES brand. Single measurements are
adequate because quality standards required for com-
mercially distributed medical devices do not allow any
relevant variation in product properties. These stand-
ards guarantee reliable characterization of a brand by
measuring one specimen.
Measurement of Pushability
In this study, pushability was defined as the ability
of the stent delivery system (SDS) to transfer the prox-
imal external force exerted by the investigator (prox-
imal force, Fprox) to the force measured at the tip of
the system (distal force, Fdist). The pushability is
essentially the amount of force lost in the system.
Improving pushability was considered with increasing
ratio of the two forces.
To measure pushability, a model of coronary circula-
tion was modified by simulating a total occlusion at the
end of a selected ‘‘vascular’’ pathway. Figure 2 shows
the experimental setup developed for the pushability
tests. The load cell (range 0–5 N, type 8432, burster
GmbH, Germany) at the distal end of the vascular path-
way includes a model of a totally occluded lesion. The
load cell measures the axial component of the distal
force, Fdist, as the stent system advances toward the total
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd.
352 Schmidt et al.
Fig. 2. Vessel model and total occlusion for measurement of
the pushability of the DES systems.
occlusion. At the beginning of each measurement, the
tip of the stent system was placed immediately in front
of the simulated occlusion (‘‘start point of test’’). The
proximal shaft was attached to the automatic linear drive
via a second load cell (measurement range 0–5 N, type
8432, burster GmbH, Germany) to measure the proximal
push force Fprox during DES delivery system advance-
ment. The stent systems were advanced at a travel speed
of 7.5 mm/s until a load-controlled test stop at a proxi-
mal push force of >4 N was reached. Both forces, Fdist
and Fprox, were measured simultaneously.
The pushability parameter was calculated from the
maximum forces of Fprox (Fprox
4 N) and the corre-
sponding distal force Fdist as follows:
Pushability ¼ ðFdist =Fprox Þ 3 100%
Only a single measurement of pushability with lim-
ited push force was performed per stent system to
exclude damage of the distal tip of the SDS during the
push against the total occlusion.
Measurement of Trackability
In this study, trackability was considered the ability
of SDS to track or move easily through a curved vas-
cular pathway. To characterize the trackability in this
experimental setup, the proximal push force required
to advance the SDS through the tubing system was
measured. The trackability is essentially a measure of
the resistance against the SDS moving through a
curved vessel pathway. The lower the push forces, the
better are the trackability.
All measurements of forces were performed using a
standardized experimental model of the left coronary
circulation developed in our laboratory [10,13,17]. The
model consists of two PMMA plates (thickness:
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd.
Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
Fig. 3. Experimental model of the left coronary artery circula-
tion. Test path 5 was used for the presented tests.
10 mm), with a milled path for the guiding catheter
which leads to the model of the coronary arteries. The
two PMMA plates are pinned and bolted together. The
diameter of the path for the guiding catheter is 2 mm,
and the milled path diameter for the coronary arteries
is 2.5 mm (Fig. 3).
Validation measurements have shown that number
and radii of the curvatures are responsible for the diffi-
culty level of the relating model path [13]. Out of the
total of eight vessel paths, all trackability tests were
performed using the paths marked in the drawing. It
was chosen as a medium difficulty path intended to
allow complete data collection for all DES systems
and to differentiate characteristic handling properties
of the stent systems. A commercially available guide
wire provided the required access to the chosen vessel.
ð1Þ The investigated stent systems are advanced over the
test path from point A, which is still inside of the
guiding catheter, until the tip of the stent system
has reached point E. The total travel distance was
220 mm. All measurements are performed in a 378C
heated water environment.
The measurements of trackability were performed
three times in each DES delivery system to reduce ran-
dom errors. To obtain a measure of the SDS’s track-
ability, the proximal track forces Fprox of each single
measurement were averaged from all three measure-
ments, and a mean track force was calculated from the
curves as follows:
1X n
Trackability ¼ Fprox ðiÞ ð2Þ
n i¼1
where n is the number of force measurements along
the entire travel path (n 5 440). The test procedure as
well as the data analysis is in accordance with the in-
ternal standard of the test laboratory [17].
 Mechanical Performance of Drug-Eluting Stent Systems
Fig. 4. Vascular and stenosis model for crossability tests.
Measurement of Crossability
In this study, crossability was considered as the abil-
ity of SDS to pass through the target lesion. To char-
acterize the crossability in this experimental setup, the
distal reactive force developed during the crossing ma-
neuver was measured. The lower the reactive force
developed during crossing of the lesion, the better is
the crossability.
To measure the crossability, the experimental setup
was modified by integrating a stenotic lesion model at
the end of the test path (Fig. 4). This lesion model is
characterized by an eccentric narrowing of the vessel
lumen from 2.5 to 1.4 mm with a conical transition.
Thus a reduction by 44% diameter (68% cross-sec-
tional lumen area) was achieved. The lesion model
allows narrowing of the lumen at either the inner ra-
dius (lesion model type 1) or at the outer radius (lesion
model type 2) of the test curvature. For this study, the
more challenging lesion model type 2 with obstruction
at the outer radius was used.
A load cell was mounted to the lesion model to pro-
vide measurements of the distal reactive force Fdist in
addition to the proximal push force Fprox. The proxi-
mal travel distance (driven by the linear actuator) was
60 mm beginning at the end of the vessel simulation
(point A) until the entire stent/balloon has passed the
stenosis model (point B).
Three measurements of SDS crossability were per-
formed for each of the SDS studied. The distal reac-
tive forces were averaged over the three measurements.
The mean distal force Fdist was calculated as the mea-
sure of crossability.
Because trackability, crossability, and pushability are
complex, mutually interacting properties of DES, not
fully defined by measurements of the proximal, distal,
and reactive forces, two additional properties of DES
were determined using straightforward physical meas-
Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
353
Fig. 5. Laser scanner employed for DES-diameter measure-
ments.
urements: the stent profile and the bending stiffness.
These parameters are likely to influence the complex
functional parameters.
Measurement of Stent Profile
The mechanical SDS behavior is potentially influ-
enced by the stent profile. To fully characterize the
contour of the entire stent-carrying SDS segment, the
mean stent profile over the entire length of the stent
segment was measured.
The stent profile, defined as the outside diameter of
the stent system with the stent crimped on the balloon
catheter, was determined using a noncontact special
laser measuring head ODAC 32XY (Zumbach Elec-
tronic GmbH) designed to make measurements in a
water bath. The operation principle of the measurement
system is shown in Fig. 5. A temperature-controlled
water filled test chamber is situated in the center of
the two-axis laser measurement head. The linear drive
motion section consists of a DC motor with encoder
and gears as well as provisions for clamping the cathe-
ter [13,18].
For the measurement, the balloon catheter with a
crimped on stent is slipped over a guide wire. The
guide wire directs the motion within the measurement
chamber such that the laser beam strikes the distal end
of the balloon. Profiles were measured in two perpen-
dicular projections along the stent axis z at every
0.2 mm [dx(z), dy(z)], thus allowing measurements of
both stent diameters along the entire stent length. All
diameter values are the mean values calculated over
the effective stent length and are stored in a data table.
The complete stent profile is obtained from the indi-
vidual measurements performed at the orthogonal x
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd.
354 Schmidt et al.

TABLE I. Summary of All Numerical Test Results

Mean Mean Crimped Bending
track cross stent stiffness of
Pushability force force profile crimped stent
Stent system (%) (N) (N) (mm) (Nmm2)
Biomatrix 35.89 0.55 0.09 1.130 30.06
Costar 38.66 0.76 0.04 1.088 22.44
Cypher Select 1 27.34 1.14 0.08 1.198 25.90
Endeavor 32.20 0.69 n.a.a 1.130 47.20
Taxus Liberté 20.91 n.a.b 0.09 1.124 17.24
Xience V 37.60 0.87 0.04 1.055 25.78
Coroflex Please 18.53 0.67 0.10 1.145 20.16
a
Medtronic Endeavor was excluded because of stent loss.
b
Taxus Liberté was excluded because of force overload after 146-mm
travel distance.

Fig. 6. Test setup for the measurement of the bending stiff-

ness of DES employed in the study. [Color figure can be
cell (Q11/10 g) has a range of 6100 mN at an accu-
viewed in the online issue, which is available at www. racy of 60.5% FS.
interscience.wiley.com.] The displacement and force data are recorded using
a computer, which is connected to the testing device
using a serial interface. The force–distance curves
and y axes. This is accomplished by generating the describe the spring modulus of the test objects for
root mean square value (RMS) of dx(z) and dy(z): bending. The bending stiffness EI is calculated taking
sffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffi the mean value of F/f calculated by linear regre-
dx2 ðzÞ þ dy2 ðzÞ ssion from the whole force–distance curve using the
dRMS ðzÞ ¼ ð3Þ equation
2

Here z denotes the measurement position at the F  l3

length axis. All the values of dRMS(z) of the scan
along the z axis are recorded as the stent profile.
For comparison purposes, the mean value of the
stent profile is calculated taking all profile values in
the region of the crimped stent.
1 X
dðpÞ ¼ dðzi Þ
n i¼1...n
where n specifies the number of diameter values in the
stent region. The inflation pressure, p, is 0 bar for the
initial state of the crimped stent.
Measurement of Bending Stiffness
Bending stiffness is a measure of the structure’s re-
sistance to bending deformation and is the reciprocal
of flexibility. Bending stiffness is a function of the ra-
tio of the bending force and the deflection of the SDS
due to this force. Thus, the larger the ratio, the higher
is the bending stiffness.
The experimental setup to determine the bending
stiffness of a crimped stent with the free bending
length l creates a deflection f of the stent, which is
applied automatically using a linear actuator. The
resulting force F is measured by a load cell. The load
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd.
Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
EI ¼ ð5Þ
3f
based on the elastic beam theory, where E is the mod-
ulus of elasticity (or Young’s modulus, a property of
the material), and I is the moment of inertia (based on
the geometry of the beam). Taking into account possi-
ble asymmetric structures of the test samples, bending
ð4Þ
stiffness is measured in five directions around the cir-
cumference and subsequently averaged. Figure 6 shows
the experimental setup to measure bending stiffness.
Validation of the experimental setups and all meas-
ured variables are provided in the literature
[10,11,13,18,19].
RESULTS
All numerical test results are summarized in Table I.
Pushability
The relationships between the measured proximal
and distal forces are shown in Fig. 7. The distal force
increases steadily with increasing proximal force after
the initial system friction (i.e., Fprox is not zero when
Fdist begins to increase). The pushability at the maxi-
mum Fprox ranged from 18.53% to 38.66%. The high-
 Mechanical Performance of Drug-Eluting Stent Systems 355

Fig. 7. Pushability. Fprox vs. Fdist developed while crushing the stent systems in the vessel
model at the total occlusion. [Color figure can be viewed in the online issue, which is avail-
able at www.interscience.wiley.com.]

est pushability was measured for the Conor Costar
DES and the lowest for the Braun Coroflex Please.
Trackability
The resulting force–distance graphs derived from the
test path 5 are given in Fig. 8. The initially low-track
forces begin to rise as the distance of DES advance-
ment (s) increases, with marked differences between
the individual DES past the 130-mm distance. The
Taxus Liberté system could not be pushed through the
entire track model since the force exceeded the maxi-
mum of 4 N after 146 mm (66.4% of the total tracking
path’s length) of tracking. The mean track forces
ranged from 0.551 N of Biosensors Biomatrix to 1.137
N of Cordis Cypher select 1.
Crossability
Figure 9 shows the measured distal reactive forces
Fdist of the stent systems across the total distance of
60 mm (A to B) required to pass through the stenotic
lesion (model 2). The mean crossing forces for all
seven DES ranged from 0.038 N (Abbott Xience V)
up to 0.103 N (Braun Coroflex Please).
Crimped Profile
The mean stent profiles of the investigated DES are
summarized in Table I. They ranged from 1.055 mm
(Abbott Xience V) to 1.198 mm (Cordis Cypher select
1).
Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
Bending Stiffness
The bending stiffnesses of the stent carrying regions
of the DES are also shown in Table I. The highest
bending stiffness of the crimped stent was measured
for the Medtronic Endeavor (47.20 Nmm2). The lowest
bending stiffness was measured for the Taxus Liberté
(17.22 Nmm2).
DISCUSSION
The mechanical behaviors of a stent may be impor-
tant for four broad categories of the stent’s life: (1)
manufacturing and packaging, (2) delivery, (3) deploy-
ment, and (4) in vivo service. The mechanical proper-
ties during both deployment and in vivo service have
been studied to some extent. A broad survey is given
in Ref. 20. However, the mechanical behavior during
delivery has received little attention.
Mechanical performance of SDS can be described
by the stent dimensions, physical properties, and com-
binations of forces required for safe and easy stent
delivery to target destinations. Typical dimensions
employed to describe SDS include their entry and the
crossing profiles. Typical systems of forces that define
their mechanical behavior have been combined and
described by their pushing, tracking, and crossing abil-
ities. Ultimately, atraumatic delivery and precise posi-
tioning of an intact stent across the target lesion are
the most basic prerequisites for a successful interven-
tion. Other than commercial product descriptions avail-
able to the interventional cardiologists, virtually no
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd.
356 Schmidt et al.

Fig. 8. Trackability. Force–distance curves from the trackability measurements (test path 5)
of the investigated stent systems are shown. [Color figure can be viewed in the online issue,
which is available at www.interscience.wiley.com.]

Fig. 9. Crossability of the DES. Fdist as a function of the travel distances (measurement with
lesion type 2). Medtronic Endeavor was excluded because of stent loss. [Color figure can be
viewed in the online issue, which is available at www.interscience.wiley.com.]

technical data on individual products have been pub- In this study, we undertook a pioneering effort to
lished, leaving the vast majority of critical mechanical define and measure objective mechanical parameters in
performance descriptors to the proprietary sector and vitro to compare mechanical performance of seven
cardiologist’s best guess. commercially available SDS products. There is no
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd.
Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
 Mechanical Performance of Drug-Eluting Stent Systems
doubt that clinical scenarios are more complex than an
in vitro simulation; however, to understand the physi-
cal properties of stent systems, and to provide the cli-
nician with the best possible guidance, we believe that
in vitro simulations are invaluable. Good performance
in vitro will not guarantee safe and easy target access
in vivo; however, poor in vitro performance very likely
indicates a risk of difficulty or complication, at least in
case of complex lesions.
Pushability, defined as the ratio of the distally and
proximally exerted forces, trackability, defined as the
sum of proximal forces required to pass a curved vas-
cular pathway, and crossability, defined as distal reac-
tive force required to pass a defined narrowing, were
selected to represent deliverability of SDS.
Although the terms of pushability, trackability, and
crossability are commonly used in the field of cardio-
vascular interventions, there is no unique definition.
Product standards for vascular stents [21,22] use the
trackability and pushability to describe the ability of a
stent system to be advanced to the lesion without SDS
damage or harm to the vasculature. This has to be
shown by the manufacturer to the authorities for product
approval. For this demonstration, suitable in vitro mod-
els may be used but no measurements are required.
Comparative design evaluation of coronary stents
was provided using among others the term of ‘‘deliver-
ability,’’ which includes tracking and lesion crossing
[23]. Evaluation was given without further definition
or provision of measured data. To our knowledge, the
only other approach leading to objectively measured
forces was using 908 and 1358 bent tortuosities and
measuring the required proximal forces needed to pass
the curvatures with different stent systems [9]. This
method is suitable for the assessment of trackability if
the pure technical design of vessel geometry can be
accepted. We improved acceptance by introducing a
technically well-defined coronary vessel model with
more realistic dimensions.
Each of the three delivery parameters (pushability,
trackability, and crossability) are based on the resisting
forces that can be quantified along some part of the
delivery path. The definitions also include a measure
of the force felt or applied by the clinician, Fprox. The
parameters will therefore potentially give the clinician
an indication of how a specific stent is progressing as
they push on the proximal end. As the arterial models
are improved and become more sophisticated, the defi-
nitions may also evolve to reflect new understanding
of stent delivery.
In addition, the bending stiffness, a function of the
ratio of the bending force and resulting deflection at
the point of load application for the mounted stents,
was also determined. The average of the sum of all
Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
357
profiles along the stent carrying segment of the balloon
catheter was selected to characterize relevant SDS
dimensions.
Our measurements showed that differences in push-
ability are on the order of 50% and in trackability on
the order of 100%. Differences in crossability and in
bending stiffness are in the range of 60%, whereas the
variation in average profile of the seven SDS studied
is in the range of 12%. The best pushability was meas-
ured for Conor CoStar-SDS (38.66%) and the lowest
for Coroflex Please-SDS (18.53%).
In all systems, the proximal pushing forces were
low, meaning good trackability at the proximal seg-
ment of the pathway. Proximal push forces increased
steadily with progression through the model. In this
study, the best trackability was measured for the Bio-
Matrix SDS (0.551 N) and the lowest for the Cypher
select1-SDS (1.137 N), i.e., a 100% increase in force
required. For our experimental setup, Taxus Liberte
had to be excluded from comparison because at 146-
mm travel distance the upper force limit (4 N) had
been exceeded.
Pushability represents the efficiency by which the
applied force is transmitted to the catheter tip, and
hence the accuracy of the feedback, or ‘‘feel’’ to the
interventionalist. A pushability of 0% can be repre-
sented by a completely flexible rope, where pushing
on the proximal end will only result in the rope’s
crimping, with no force transmitted to the distal end.
A pushability of 0% could also be achieved by the
case where the shear resistance of the vessel wall
along the length of the SDS is greater than or equal to
the proximal force, thus preventing any transmission to
the distal end. Conversely, a pushability of 100% can
be represented by a perfectly rigid rod, where all of
the proximal force is transmitted to the distal end. In
the experimental system, this could be achieved only if
there were no losses along the SDS length. Thus, push-
ability represents the loss of force from interactions
between the vessel walls and the SDS. For a given
vessel wall architecture, differences in pushability must
arise from differences in the SDSs; such differences
most likely originate from differences in SDS surfaces,
such as surface roughness, composition, or actual con-
tact area among others, giving rise to frictional resist-
ance. The Conor CoStar (Fig. 1) shows a smooth metal
surface with many undulations and small structural ele-
ments, which may allow for better lubrication, and
hence easier passage. The Braun Coroflex Please, in
contrast, appears to have a rougher polymer coating
and larger structural elements, both of which may lead
to greater friction between the SDS and the vessel
wall. The bending stiffness of the stent system will
also contribute to the pushability. A stiffer stent system
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd.
358 Schmidt et al.
may transmit force more efficiently because it will act
more like the rigid rod example; however, a stiffer
system will also not conform to a curved segment of a
vessel, and hence potentially result in greater contact
forces, which will reduce the force transmission and
hence pushability.
Trackability depends on the facility of the SDS to
negotiate curved portions of the model test track. In
each of the SDS tested (Fig. 1), the devices are seg-
mented, that is, they are designed with individual sec-
tions connected by structural ‘‘struts.’’ The ability of
the SDS to bend and twist through tortuous vessels
will most likely depend on the ability of the ‘‘strutted’’
connections, rather than the more rigid segments, to
bend. The ability of the struts to bend will depend on
both their geometry and material. It would seem that
trackability and bending stiffness, where a lower bend-
ing stiffness means that the SDS is more deformable,
should be related; however, two of the three SDSs
with the best trackability (e.g., #1-Biosensors BioMa-
trix and #3-Medtronic Endeavor) had the greatest
bending stiffness in the stent region. The second best
trackability (Braun Coroflex) also had the second low-
est bending stiffness. The SDS with the lowest bending
stiffness (Taxus Liberte) had such a high trackability
force and poor trackability performance that it could
not complete the experimental task. This suggests three
explanations. First, there is an optimum system bend-
ing stiffness that results in good trackability. The data
suggest that a stiffer device is required to overcome
the resisting forces generated in a curved vessel. Sec-
ond, the bending stiffness is a combination of the stent
material, through the material property ‘‘E’’, the
Young’s modulus, or elastic stiffness—and the stent
geometry—through the moment of inertia term, ‘‘I’’
[from Eq. (5)]. The equation used to determine the
bending stiffness [Eq. (5)] assumes that the beam is a
continuous solid, and it is evident that the stents are
not. The third possibility is that the boundary condi-
tions in the experimental model, and in vivo, are more
complex than our single-fixed-end cantilever beam
model (which also assumes a homogeneous solid struc-
ture), and that a different bending model may provide
different results. It should be evident that a very stiff
stent requires a high force to conform and pass
through small radii of curvature of this model. Cathe-
ters on which the stents are mounted play an equally
important role. In our studies, the stiffness of the cath-
eters was not precisely characterized. Nevertheless, our
test method allows a simple, easy, and precise compar-
ative measurement of trackability, which is important
for clinical application.
Crossability depends, in addition to the same param-
eters that control trackability, mainly on the profile of
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd.
Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
the crimped stent. The stent system with good track-
ability (Braun Coroflex Please) fared the worst in
crossability. Another stent system with poorer track-
ability (Abbott Xience) fared the best in crossability.
This suggests that trackability is not the governing pa-
rameter for crossability.
In contrast, the Xience V and the Conor CoStar,
which have the smallest profile, also have the best
crossability in this test, even though both stents have
small and tortuous structural elements. These results
suggest that it is definitely important and an advantage
to have a small, smooth profile of the balloon with the
crimped stent. The crossability will also depend, in
part, on the stiffness of the lesion. The stiffness, or
mechanical responses, of a lesion (that is, how easy is
it to push the lesion out of the way as the stent pro-
gresses through) is lesion dependent [24,25]. This
effect was not simulated in our model.
The measurements of pushability, trackability, and
crossability as defined in this study establish the first
systematic, quantitative framework for rigorous com-
parisons of mechanical properties of DES systems.
Safe and atraumatic passage of DES to the target sites
and their precise positioning across the target lesions
depend on the facility of delivery in the endovascular
environment. For example, in the majority of anatomi-
cally straightforward cases, specification of standard or
average mechanical properties of the SDS shall suffice.
With increasing hostility of the upstream vascular seg-
ment and tightness and complexity of the target lesion,
the mechanical properties of SDS become increasingly
critical. Ultimately, an ideal combination of individual
mechanical properties shall characterize a perfect SDS
product; however, in the real world, SDS products typ-
ically feature different strengths and weaknesses in
their clinical mechanical performance. For the inter-
ventionist, it appears important to select the most
appropriate instrument for a given vascular territory.
Appropriate selection, however, depends on under-
standing the mechanical behavior and differences
between individual products.
In challenging endovascular anatomy, usually more
than one important mechanical property of SDS may
come in to play. Clinical scenarios exist that have par-
ticularly demanding, specific performance parameters.
As an example, greater SDS-pushability may become
particularly important in patients with narrow proximal
access, such as seen in patients with small vessels and
diffuse disease. Similar demands are expected in
patients with diffuse or severe focal calcifications of
the upstream segments of the target vessel. Likewise,
excellent trackability is required in patients with
highly tortuous proximal vessels, particularly if com-
bined with diffuse and/or calcific disease and distal
 Mechanical Performance of Drug-Eluting Stent Systems
target lesions. High demands on crossability can be
expected in cases with tight and complex target
lesions. Low bending stiffness appears to be particu-
larly beneficial in cases with narrow take offs of tar-
get vessels and tight bends in tortuous vascular path-
ways. Low-profile SDS devices appear to be prerequi-
sites in cases with extremely tight and complex target
lesions.
If manufacturers define and quantify mechanical
behaviors of their stents during delivery, the data are
not often available to the clinical community. The
behavior definitions and measurement methods may
also vary from manufacturer to manufacturer. In the
absence of logical and consistent definitions for quanti-
fying mechanical behaviors during stent delivery, it is
impossible to compare and contrast the behaviors of
different SDS. At ASTM Committee F04 on Medical
and Surgical Materials and Devices, subcommittee
F04.30 on Cardiovascular Standards, a task group is
currently developing a ‘‘Guide for endovascular de-
vice trackability and pushability’’ that may help to
address the consistency of such measurements [26].
By creating and using consistent and meaningful defi-
nitions for delivery behaviors, facilities independent
of manufacturers may be able to provide the clinician
specific information they need to insure that the best
possible intervention is applied to each specific clini-
cal case.
Developing a better systematic understanding of
mechanical properties of SDS will improve the selec-
tion of optimal instrumentation and markedly improve
the technical operator’s performance, particularly in
challenging cases. This work provides an initial
incentive to develop this important technical frame-
work.
LIMITATIONS OF THE STUDY
In these initial tests, only one single specimen of
each brand was tested. Although the stringent regula-
tions imposed on production of medical devices should
assure a uniform mechanical behavior between all
stents of the same brand, variability of mechanical
properties of individual products has not yet been stud-
ied for the DES systems of this study.
The in vitro experimental setting represents another
limitation of this study. Our stationary experimental in
vitro vessel model consists of a plastic construct with
smooth internal surface. It represents only an approxi-
mation of the complex in vivo endovascular ‘‘tunnels’’
with highly corrugated endoluminal interfaces and
neglects the complex boundary interactions between
the vessel wall and the SDS. However, our stand-
ardized and validated experimental setup allows
Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
359
reproducible measurements of well-defined physical
variables.
Pushing, tracking, and crossing abilities are compos-
ite parameters of the DES mechanical properties that
do not lend themselves to straightforward measure-
ments. Their expressions in terms of active and reac-
tive forces may represent simplifications allowing only
limited insights into their complex nature. Neverthe-
less, exact measurements of the forces developed
during insertion allow objective comparisons of DES
devices.
SUMMARY
This study reports, for the first time, objective meas-
urements of DES performance and compares mechani-
cal responses of seven representative commercially
available DES systems. Differences in pushability,
crossability, and trackability were found. The data sug-
gest that a small profile is necessary for good cross-
ability. Trackability and pushability are complex pa-
rameters influenced by many variables such as the
stiffness of the stent system and the friction between
the system and the vasculature.
Systematic comparison as described here and a bet-
ter understanding of the mechanical properties of DES
systems may allow a more precise selection of the
DES system appropriate for the known and expected
characteristics of the target sites in individual patients
and in other clinical settings.
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