Zilver PTX Delivery System

Cook Group

Status: Completed

Conditions: Peripheral Vascular Disease

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02271529

13-14

Details and patient eligibility

About

The objective of this study is to evaluate the performance of the Zilver PTX stent thumbwheel delivery system.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient has symptomatic vascular disease of the native above-the-knee femoropopliteal arteries
• Patient has atherosclerotic lesion of the above-the-knee femoropopliteal artery

Exclusion criteria

• Patient is < 18 years of age
• Patient unable to complete required follow-up assessments
• Patient unwilling to sign and date the informed consent
• Simultaneous participation in another investigational drug or device study
• Pregnant, breastfeeding or planning to become pregnant in the next 5 years
• Additional medical/anatomical restrictions as specified in the Clinical Investigation Plan

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Drug Eluting Stent

Experimental group

Description:

Zilver® Paclitaxel(PTX)® Drug-Eluting Peripheral Stent

Treatment:

Device: Zilver® PTX® Drug-Eluting Peripheral Stent