Evaluation of the Zilver® PTX® Drug-Eluting Peripheral Stent for Treatment of Lesions of the Above-the-Knee Femoropopliteal Artery

Cook Group Incorporated9 sites in 1 country178 target enrollmentJune 2014

ConditionsPeripheral Artery Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Peripheral Artery Disease
Sponsor: Cook Group Incorporated
Enrollment: 178
Locations: 9
Primary Endpoint: Primary Patency as Assessed by Duplex Ultrasonography
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this study is to evaluate the Zilver® PTX® Drug-Eluting Peripheral Stent for treatment of lesions of the above-the-knee femoropopliteal artery in a Chinese patient population.

Registry

clinicaltrials.gov

Start Date

June 2014

End Date

February 9, 2017

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Cook Group Incorporated

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Symptoms of peripheral arterial disease corresponding to Rutherford Classification 2-4
•Stenotic (\>50% diameter stenosis) or occluded lesion of the above-the knee femoropopliteal artery
•Reference vessel diameter of 4-9 mm
•Lesion length up to 140 mm

Exclusion Criteria

•Unsuccessful arterial interventional treatment of the legs within 30 days prior to the study procedure
•Previous stent in the study vessel
•Bypass graft with an anastomosis in the study vessel
•Significant stenosis or occlusion of inflow tract not successfully treated prior to treating the study lesion
•No patent vessel of runoff