Zilver® PTX® in China

Cook Group

Status: Completed

Conditions: Peripheral Artery Disease

Treatments: Device: Zilver® PTX® Drug-Eluting Peripheral Stent

Study type: Interventional

Funder types: Industry

Identifiers

NCT02171962

13-008

Details and patient eligibility

About

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.

Enrollment: 178 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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178 participants in 1 patient group

Zilver® PTX® VI

Experimental group

Treatment:

Device: Zilver® PTX® Drug-Eluting Peripheral Stent