Zilver® PTX® V Clinical Study

Cook Group

Status: Completed

Conditions: Peripheral Arterial Disease

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01901289

12-004

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Drug-Eluting Stent

Experimental group

Treatment:

Device: Zilver® PTX® Drug-Eluting Peripheral Stent