Zilver® PTX® Drug-Eluting Peripheral Stent Post-Approval Study

Cook Research Incorporated17 sites in 1 country200 target enrollmentAugust 2013

ConditionsPeripheral Arterial Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Peripheral Arterial Disease
Sponsor: Cook Research Incorporated
Enrollment: 200
Locations: 17
Primary Endpoint: Patients Without Target Lesion Revascularization (TLR)
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The Zilver® PTX® V Clinical Study is a post-market clinical trial required by the US FDA to provide continued evaluation of the safety and effectiveness of the Zilver PTX Drug-Eluting Peripheral Stent in treatment of narrowing of the femoropopliteal arteries.

Registry

clinicaltrials.gov

Start Date

August 2013

End Date

February 15, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Cook Research Incorporated

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient has signed and dated the informed consent.
•Patient has symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.
•Patient agrees to return for the required follow-up assessments.

Exclusion Criteria

•Patient is \< 18 years of age.
•Patient has significant stenosis of inflow tract not successfully treated before this procedure.
•Patient lacks at least one patent vessel of runoff with \< 50% stenosis throughout its course.

Outcomes

Primary Outcomes

Patients Without Target Lesion Revascularization (TLR)

Time Frame: 1 year

A reintervention performed for ≥ 50 % diameter stenosis within ± 5 mm proximal and /or distal to the target lesion after documentation of recurrent clinical symptoms of peripheral arterial disease (PAD) following the initial procedure.