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

This study has been completed.
W.L.Gore & Associates
Information provided by:
Texas Vascular Associates Identifier:
First received: August 19, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
A retrospective review with four year followup on patients that had previously been enrolled in a study to evaluate blockages in the lower legs. The study looked at patients that had undergone a bypass of the leg from the groin to the knee area with an incision in each area using general anesthesia. These patients were compared to others who had undergone treatment with balloon dilatation and stents in the arteries in the thighs with only numbing medicine. The study was completed two years ago and was initially designed to look at outcomes at 24 months. Now the investigators are trying to go back and look at outcomes of these patients' treatment at 4 years by simply reviewing their records.

Condition Intervention
Lower Extremity Ischemia
Rest Pain
Procedure: Femoral-popliteal bypass
Procedure: Stent-graft placement

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: A Retrospective Review of Randomized Comparison of Prosthetic Femoropopliteal Bypass Versus Viabahn Endoprosthesis for Treatment of Symptomatic Femoral Artery Occlusion With Four Years Followup

Further study details as provided by Texas Vascular Associates:

Primary Outcome Measures:
  • Primary artery/graft patency [ Time Frame: 48 months ]

Secondary Outcome Measures:
  • Secondary artery/graft patency [ Time Frame: 48 months ]
  • Limb salvage [ Time Frame: 48 months ]
  • Improvement of lower extremity ischemic symptoms [ Time Frame: 48 months ]

Enrollment: 100
Study Start Date: September 2003
Study Completion Date: July 2009
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Surgical Bypass Group
Those patients that underwent bypass of blockage in the thigh with surgery.
Procedure: Femoral-popliteal bypass
Surgical bypass of blockage in the thigh
Stent-graft group
Patients that underwent treatment of blockage in the thigh with balloon angioplasty and stent placement.
Procedure: Stent-graft placement
Patients that underwent treatment of blockage in the thigh arteries with balloon angioplasty with stent-graft placement.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Vascular surgery clinic patients with ischemic symtpom of the lower extremities. Patients were previously enrolled in a randomized prospective study comparing treatment of blockage in the legs with a surgical bypass or percutaneous covered stent placemnt.

Inclusion Criteria:

  • Symptomatic lower extremity ischemia patients treated by femoral-popliteal bypass or percutaneous covered stent graft in previous prospective study

Exclusion Criteria:

  Contacts and Locations
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Please refer to this study by its identifier: NCT00962897

United States, Texas
Texas Vascular Associates
Dallas, Texas, United States, 75226
Sponsors and Collaborators
Texas Vascular Associates
W.L.Gore & Associates
Principal Investigator: Dennis R Gable, M.D. Texas Vascular Associates
  More Information

Responsible Party: Dennis Gable, MD, Texas Vascular Associates/Baylor University Medical Center Identifier: NCT00962897     History of Changes
Other Study ID Numbers: 009-198, Viabahn #2
Study First Received: August 19, 2009
Last Updated: August 19, 2009

Keywords provided by Texas Vascular Associates:
covered stent
percutaneous intervention

Additional relevant MeSH terms:
Pathologic Processes
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases processed this record on April 28, 2017