Zilver® PTX® V Clinical Study

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.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Palo Alto Health Care System, Palo Alto, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Zilver® PTX® Drug-Eluting Peripheral Stent

Device

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

Primary outcomes

Patients Without Target Lesion Revascularization (TLR)

Time frame: 1 year

A reintervention performed for ≥ 50 % diameter stenosis within ± 5 mm proximal and /or distal to the target lesion after documentation of recurrent clinical symptoms of peripheral arterial disease (PAD) following the initial procedure.

Sponsors and collaborators

Lead sponsor

Cook Research Incorporated

Industry

Registry information

Official study title

Zilver® PTX® Drug-Eluting Peripheral Stent Post-Approval Study

Important dates

Study start: 2013
Primary completion: 2016
Study completion: 2021
First posted: Jul 17, 2013
Registry last updated: Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed