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Zilver® PTX® V Clinical Study | Clinical Trials | Clareo Health

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Zilver® PTX® V Clinical Study

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

NCT01901289•Cook Research Incorporated

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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.

Locations (17)

VA Palo Alto Health Care System

Palo Alto, California, United States

Stanford University Medical School

Stanford, California, United States

Washington Hospital Center

Washington D.C., District of Columbia, United States

The Cardiac and Vascular Institute

Gainesville, Florida, United States

University of Florida

Gainesville, Florida, United States

First Coast Cardiovascular Institute

Jacksonville, Florida, United States

Alexian Brothers Medical Center

Elk Grove Village, Illinois, United States

Bayview Medical Center

Baltimore, Maryland, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Columbia University Medical Center

New York, New York, United States

Key Dates

Start Date

August 1, 2013

Primary Completion Date

November 18, 2016

Completion Date

February 15, 2021

Last Updated

March 2, 2022

Enrollment

200

ACTUAL participants

Conditions

Peripheral Arterial Disease

Interventions

Zilver® PTX® Drug-Eluting Peripheral Stent

DEVICE

Symptomatic and Systemic Atherosclerotic Plaque Activity in Patients With Peripheral Arterial Disease Using Novel Imaging

NCT07472049

Peripheral Arterial DiseaseChronic Limb Threatening Ischemia

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RECRUITING

Advanta VXT and Flixene PMCF Registry

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 2, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Zilver® PTX® V Clinical Study

Inclusion Criteria

Exclusion Criteria

Symptomatic and Systemic Atherosclerotic Plaque Activity in Patients With Peripheral Arterial Disease Using Novel Imaging

Advanta VXT and Flixene PMCF Registry

Intervascular Post-Market Clinical Follow-Up (PMCF) Registry

VITUS Post-Market Registry

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