Zilver® PTX® in China

Not Applicable

Completed

• Conditions: Peripheral Artery Disease
• Interventions: Device: Zilver® PTX® Drug-Eluting Peripheral Stent

• Registration Number: NCT02171962
• Lead Sponsor: Cook Group Incorporated

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-18
• Study First Submitted QC: 2014-06-20
• Study First Posted: 2014-06-24
• Primary Completion: 2015-12
• Study Completion: 2017-02-09
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-21
• Last Update Posted: 2017-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 178

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Zilver® PTX® VI	Zilver® PTX® Drug-Eluting Peripheral Stent	-

Primary Outcome Measures

Name	Time	Method
Primary Patency as Assessed by Duplex Ultrasonography	12 months

Trial Locations

Locations (9)

China-Japan Friendship Hospital; 🇨🇳 Beijing, China

Peking University People's Hospital; 🇨🇳 Beijing, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, China

Shanghai Ninth People's Hospital Affiliated Shanghai JiaoTong University School of Medicine; 🇨🇳 Shanghai, China

Zhongshan Hospital Fudan University; 🇨🇳 Shanghai, China

Renji Hospital Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, China

Chinese PLA General Hospital; 🇨🇳 Beijing, China

Beijing Anzhen Hospital; 🇨🇳 Beijing, China

Peking University First Hospital; 🇨🇳 Beijing, China