Zilver PTX Drug-Eluting Peripheral Stent Study

Not Applicable

Completed

• Conditions: Peripheral Arterial Disease
• Interventions: Device: Shorter Zilver PTX Stents; Device: Longer Zilver PTX Stents

• 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

Study Timeline

• Study First Submitted: 2011-04-29
• Study Start: 2011-05
• Study First Submitted QC: 2011-05-04
• Study First Posted: 2011-05-05
• Primary Completion: 2011-10
• Study Completion: 2012-09
• Disposition First Submitted: 2013-03-12
• Disposition First Submitted QC: 2013-03-12
• Disposition First Posted: 2013-03-19
• Results First Submitted: 2013-07-25
• Status Verified: 2014-03
• Results First Submitted QC: 2014-03-11
• Results First Posted: 2014-04-16
• Last Update Submitted: 2015-12-29
• Last Update Posted: 2016-02-02

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

Arm && Interventions

Group	Intervention	Description
Shorter Stents	Shorter Zilver PTX Stents	-
Longer Stents	Longer Zilver PTX Stents	-

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)

Trial Locations

Locations (4)

INSELSPITAL, Universitätsspital Bern; 🇨🇭 Berne, Switzerland

Herz-Zentrum; 🇩🇪 Bad Krozingen, Germany

Universitätsklinikum Magdeburg A.ö.R.; 🇩🇪 Magdeburg, Germany

Evangelische Krankenhaus Königin Elisabeth Herzberge; 🇩🇪 Berlin, Germany