Comparison of Prosthetic Femoropopliteal Bypass Versus Viabahn Endoprosthesis for Treatment of Symptomatic Femoral Artery Occlusive Disease

This study has been completed.
Sponsor:
Collaborator:
W.L.Gore & Associates
Information provided by:
Texas Vascular Associates
ClinicalTrials.gov Identifier:
NCT00693823
First received: June 3, 2008
Last updated: June 6, 2008
Last verified: June 2008
  Purpose

This study is a comparison of two different ways to treat blockage in the artery of the thigh. The first is an older way with incisions in the groin and just above the knee. A plastic tube is then inserted to make a bypass from the groin to the knee. The second treatment offered is through a needle hole in the groin. A thin plastic tube covering a metal stent is inserted into the artery and released to bypass the blockage from inside the artery. No incisions are needed. Patients are enrolled and then selected for one treatment method or another by chance. The patients will be followed for two years to see how the two different treatment methods work compared to each other.


Condition Intervention
Atherosclerosis
Lower Extremity Ischemia
Claudication
Rest Pain
Procedure: Femoral-popliteal Bypass
Device: Angioplasty and stent placement with Viabahn covered stent-graft(W.L. Gore & Associates, Flagstff, Arizona) of superficial femoral artery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Randomized Comparison of Prosthetic Femoropopliteal Bypass Versus Viabahn Endoprosthesis for Treatment of Symptomatic Superficial Femoral Artery Occlusion

Resource links provided by NLM:


Further study details as provided by Texas Vascular Associates:

Primary Outcome Measures:
  • Primary artery/graft patency [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Limb Salvage [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Improvement in symptoms of lower extremity Ischemia [ Time Frame: 24 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary artery/graft patency [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Enrollment: 86
Study Start Date: September 2003
Study Completion Date: January 2008
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Femoral-popliteal surgical bypass with prosthetic graft
Procedure: Femoral-popliteal Bypass
Surgical placement of a prosthetic graft in the thigh from the groin to the knee
Active Comparator: 2
Interventional angioplasty and placement of an ePTFE covered stent graft within the femoral-popliteal artery as an endoluminal bypass percutaneously
Device: Angioplasty and stent placement with Viabahn covered stent-graft(W.L. Gore & Associates, Flagstff, Arizona) of superficial femoral artery
Placement of an ePTFE covered stent graft within the superficial femoral artery in the thigh through a needle hole percutaneously
Other Name: Viabahn endoprosthesis

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:Patients that had atherosclerotic stenotic or occlusive lesions of the superficial femoral artery with no significant aorto-iliac disease. The infra-popliteal segment had to be patent with at least single vessel run-off to the ankle. Patients had to be acceptable surgical candidates in the event they were randomized to the surgical arm.

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Exclusion Criteria:Non-operative candidate,Contraindication to IV contrast use, Planned surgery with venous conduit, previously stented segment of the superficial femoral artery, poorly compliant patient.

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  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 ClinicalTrials.gov identifier: NCT00693823

Locations
United States, Texas
Baylor University Medical Center
Dallas, Texas, United States, 75226
Sponsors and Collaborators
Texas Vascular Associates
W.L.Gore & Associates
  More Information

Publications:
Responsible Party: Dennis R. Gable, M.D., Texas Vascular Associates/Baylor University Medical Center
ClinicalTrials.gov Identifier: NCT00693823     History of Changes
Other Study ID Numbers: 003-179, Viabahn #1
Study First Received: June 3, 2008
Last Updated: June 6, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Texas Vascular Associates:
atherosclerosis
stent
angioplasty
covered stent

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 02, 2014