Trial record 1 of 1 for:    NCT01901289
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Zilver® PTX® V Clinical Study

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Cook Identifier:
First received: July 8, 2013
Last updated: November 23, 2015
Last verified: November 2015
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 Intervention
Peripheral Arterial Disease
Device: Zilver® PTX® Drug-Eluting Peripheral Stent

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Zilver® PTX® Drug-Eluting Peripheral Stent Post-Approval Study

Resource links provided by NLM:

Further study details as provided by Cook:

Primary Outcome Measures:
  • Occurrence of target lesion revascularization (TLR). [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Target lesion revascularization (TLR) [ Time Frame: annually through five years post-procedure. ] [ Designated as safety issue: Yes ]
  • Stent Integrity [ Time Frame: one, three, and five years post-procedure. ] [ Designated as safety issue: No ]
  • Stent thrombosis [ Time Frame: annually through five years post-procedure. ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: August 2013
Estimated Study Completion Date: April 2021
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Drug-Eluting Stent Device: Zilver® PTX® Drug-Eluting Peripheral Stent
Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

No publications provided

Responsible Party: Cook Identifier: NCT01901289     History of Changes
Other Study ID Numbers: 12-004
Study First Received: July 8, 2013
Last Updated: November 23, 2015
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Cardiovascular Diseases
Vascular Diseases processed this record on December 01, 2015