Zilver® PTX® in China

Peripheral Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02171962
• Other study ID #: 13-008
• Status: Completed
• Phase: N/A
• First received: June 18, 2014
• Last updated: March 21, 2017
• Start date: June 2014
• Est. completion date: February 9, 2017

Study information

• Verified date: March 2017
• Source: Cook
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: February 9, 2017
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

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

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital	Beijing
China	China-Japan Friendship Hospital	Beijing
China	Chinese PLA General Hospital	Beijing
China	Peking Union Medical College Hospital	Beijing
China	Peking University First Hospital	Beijing
China	Peking University People's Hospital	Beijing
China	Renji Hospital Shanghai Jiaotong University School of Medicine	Shanghai
China	Shanghai Ninth People's Hospital Affiliated Shanghai JiaoTong University School of Medicine	Shanghai
China	Zhongshan Hospital Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Cook

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Patency as Assessed by Duplex Ultrasonography		12 months