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Zilver® PTX® V Clinical Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01901289
Recruitment Status : Active, not recruiting
First Posted : July 17, 2013
Last Update Posted : November 20, 2017
Information provided by (Responsible Party):
Cook Group Incorporated

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 in treatment of narrowing of the femoropopliteal arteries.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Device: Zilver® PTX® Drug-Eluting Peripheral Stent Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Zilver® PTX® Drug-Eluting Peripheral Stent Post-Approval Study
Study Start Date : August 2013
Actual Primary Completion Date : November 18, 2016
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Drug-Eluting Stent Device: Zilver® PTX® Drug-Eluting Peripheral Stent
Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.

Primary Outcome Measures :
  1. Freedom from 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01901289

United States, California
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304
Stanford University Medical School
Stanford, California, United States, 94305
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
The Cardiac and Vascular Institute
Gainesville, Florida, United States, 32605
University of Florida
Gainesville, Florida, United States, 32610
First Coast Cardiovascular Institute
Jacksonville, Florida, United States, 32216
United States, Illinois
Alexian Brothers Medical Center
Elk Grove Village, Illinois, United States, 60007
United States, Maryland
Bayview Medical Center
Baltimore, Maryland, United States, 21224
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
New York-Presbyterian/ Weill Cornell Medical Center
New York, New York, United States, 10065
United States, Ohio
OhioHealth Research Institute
Columbus, Ohio, United States, 43214
University of Toledo Medical Center
Toledo, Ohio, United States, 43614
United States, Pennsylvania
Holy Spirit Hospital
Camp Hill, Pennsylvania, United States, 17011
United States, South Carolina
South Carolina Heart Center
Columbia, South Carolina, United States, 29204
Greenville Hospital System
Greenville, South Carolina, United States, 29615
United States, Tennessee
Holston Valley Hospital
Kingsport, Tennessee, United States, 37660
Sponsors and Collaborators
Cook Group Incorporated

Responsible Party: Cook Group Incorporated Identifier: NCT01901289     History of Changes
Other Study ID Numbers: 12-004
First Posted: July 17, 2013    Key Record Dates
Last Update Posted: November 20, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No

Keywords provided by Cook Group Incorporated:
Peripheral Vascular Disease
Femoral Artery
Popliteal Artery
Drug-Eluting Stent

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases