Zilver PTX Delivery System

N/ACompletedNCT02271529

Cook Group Incorporated40 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Peripheral Vascular Disease

Interventions

Zilver® PTX® Drug-Eluting Peripheral StentDEVICE

Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

Frankston Hospital

Frankston, Australia

Princess Alexandra Hospital

Woolloongabba, Australia

Universitäts-Herzzentrum Freiburg - Bad Krozingen GmbH

Bad Krozingen, Germany

Auckland City Hospital

Auckland, New Zealand

Outcomes

Primary Outcomes

Mean Percent Change in Stent Length Upon Deployment

Time frame: Immediately following completion of the stent placement procedure

Data from ClinicalTrials.gov

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