Zilver PTX Drug-Eluting Peripheral Stent Study
Not Applicable
Completed
- Conditions
- Peripheral Arterial Disease
- Registration Number
- NCT01348425
- Lead Sponsor
- Cook Group Incorporated
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Percent Change in Stent Length Upon Deployment During Procedure (day 1) (Prior to Stent Deployment and after Stent Deployment)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Herz-Zentrum
🇩🇪Bad Krozingen, Germany
Evangelische Krankenhaus Königin Elisabeth Herzberge
🇩🇪Berlin, Germany
Universitätsklinikum Magdeburg A.ö.R.
🇩🇪Magdeburg, Germany
INSELSPITAL, Universitätsspital Bern
🇨🇭Berne, Switzerland
Herz-Zentrum🇩🇪Bad Krozingen, Germany