Zilver® PTX® in China

N/ACompletedNCT02171962

Cook Group Incorporated178 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

178

Conditions

Peripheral Artery Disease

Interventions

Zilver® PTX® Drug-Eluting Peripheral StentDEVICE

Zilver® PTX® Drug-Eluting Peripheral Stent for treatment of lesions of the above-the-knee femoropopliteal artery

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (9)

Beijing Anzhen Hospital

Beijing, China

China-Japan Friendship Hospital

Beijing, China

Peking University First Hospital

Beijing, China

Peking University People's Hospital

Beijing, China

Outcomes

Primary Outcomes

Primary Patency as Assessed by Duplex Ultrasonography

Time frame: 12 months

Data from ClinicalTrials.gov

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