Zilver® PTX® V Clinical Study

N/ACompletedNCT01901289

Cook Research Incorporated200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Peripheral Arterial Disease

Interventions

Zilver® PTX® Drug-Eluting Peripheral StentDEVICE

Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (17)

VA Palo Alto Health Care System

Palo Alto, California, United States

Stanford University Medical School

Stanford, California, United States

Outcomes

Primary Outcomes

Patients Without Target Lesion Revascularization (TLR)

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.

Time frame: 1 year

Data from ClinicalTrials.gov

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