Status:
COMPLETED
Zilver® PTX® V Clinical Study
Lead Sponsor:
Cook Research Incorporated
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2021
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01901289
Start Date
August 1 2013
End Date
February 15 2021
Last Update
March 2 2022
Active Locations (17)
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1
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304
2
Stanford University Medical School
Stanford, California, United States, 94305
3
Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
4
The Cardiac and Vascular Institute
Gainesville, Florida, United States, 32605