Zilver® PTX® V Clinical Study

Completed · Not applicable

Conditions studied: Peripheral Arterial Disease

In brief

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.

Key facts

Study ID

NCT01901289

Run by

Cook Research Incorporated

People needed

200

Starts

2013-08-01

Expected to finish

2021-02-15

Last updated by the study team

2022-03-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• New York-Presbyterian/ Weill Cornell Medical Center — New York, New York, United States
• OhioHealth Research Institute — Columbus, Ohio, United States
• University of Toledo Medical Center — Toledo, Ohio, United States
• Holy Spirit Hospital — Camp Hill, Pennsylvania, United States
• South Carolina Heart Center — Columbia, South Carolina, United States
• Greenville Hospital System — Greenville, South Carolina, United States
• Holston Valley Hospital — Kingsport, Tennessee, United States

Full record on ClinicalTrials.gov

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