Evaluation of the Zilver PTX Drug-Eluting Peripheral Stent

Cook Group Incorporated4 sites in 2 countries45 target enrollmentMay 2011

ConditionsPeripheral Arterial Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Peripheral Arterial Disease
Sponsor: Cook Group Incorporated
Enrollment: 45
Locations: 4
Primary Endpoint: Percent Change in Stent Length Upon Deployment
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2011

End Date

September 2012

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Cook Group Incorporated

Responsible Party

Sponsor

Eligibility Criteria

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