Peripheral Arterial Disease
Conditions
Keywords
PAD
Brief summary
This randomized, post-market clinical study is intended to evaluate the delivery and deployment of longer Zilver PTX stents (≥ 100 mm) compared to shorter Zilver PTX stents (≤80 mm) for treatment of lesions of the above-the-knee femoropopliteal artery.
Interventions
DEVICELonger Zilver PTX Stents
Treatment with at least one 100 mm or longer Zilver PTX stent
DEVICEShorter Zilver PTX Stents
Treatment with Zilver PTX stents 80 mm or shorter only
Sponsors
Cook Group Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* One de novo or restenosed artherosclerotic lesion with \> 50% diameter stenosis * Reference vessel diameter of 4 - 9 mm * Rutherford category ≥ 2 * Resting ankle brachial index \< 0.9
Exclusion criteria
* Prior stent in the study vessel * Significant stenosis (\> 50%) or occlusion of inflow tract not successfully treated before the study procedure * Lacks at least one patent runoff vessel * Lesions requiring atherectomy, cutting balloons, cryoplasty balloons, or any other advanced device to facilitate stent delivery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change in Stent Length Upon Deployment | During Procedure (day 1) (Prior to Stent Deployment and after Stent Deployment) |
Countries
Germany, Switzerland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Longer Stents Longer Zilver PTX Stents : Treatment with at least one 100 mm or longer Zilver PTX stent | 31 |
| Shorter Stents Shorter Zilver PTX Stents : Treatment with Zilver PTX stents 80 mm or shorter only | 14 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Imaging was not taken. | 1 | 1 |
Baseline characteristics
| Characteristic | Longer Stents | Shorter Stents | Total |
|---|---|---|---|
| Age, Continuous | 67.6 years STANDARD_DEVIATION 9.2 | 71.6 years STANDARD_DEVIATION 8.3 | 68.8 years STANDARD_DEVIATION 9 |
| Sex: Female, Male Female | 8 Participants | 5 Participants | 13 Participants |
| Sex: Female, Male Male | 23 Participants | 9 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 45 |
| serious Total, serious adverse events | 5 / 45 |
Outcome results
Primary
Percent Change in Stent Length Upon Deployment
Time frame: During Procedure (day 1) (Prior to Stent Deployment and after Stent Deployment)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Longer Stents | Percent Change in Stent Length Upon Deployment | 0.5 Change in stent length (%) | Standard Deviation 4.2 |
| Shorter Stents | Percent Change in Stent Length Upon Deployment | -0.2 Change in stent length (%) | Standard Deviation 3.8 |
Comparison: The alternative hypothesis is equivalence in mean change in stent length upon deployment between longer and shorter stents, i.e., the difference in mean change between the longer and shorter stents is close to 0. Thus, a small p-value indicates a 95% confidence interval covers 0.p-value: <0.0195% CI: [-2, 3.5]t-test, 2 sided