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OpenTrials
Completed

NCT Number: NCT00962897

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

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.

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Key information

Conditions

Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Claudication Intermittent Claudication Lower Extremity Ischemia Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Rest Pain Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Texas Vascular Associates

Dallas, Texas, 75226, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • NA

Treatment and study plan

Femoral-popliteal bypass

Procedure

Surgical bypass of blockage in the thigh

Stent-graft placement

Procedure

Patients that underwent treatment of blockage in the thigh arteries with balloon angioplasty with stent-graft placement.

Primary outcomes

  1. Primary artery/graft patency

    Time frame: 48 months

Secondary outcomes

  1. Secondary artery/graft patency

    Time frame: 48 months

  2. Limb salvage

    Time frame: 48 months

  3. Improvement of lower extremity ischemic symptoms

    Time frame: 48 months

Sponsors and collaborators

Lead sponsor

Texas Vascular Associates

Other

Collaborators

  • W.L.Gore & Associates

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2007
Study completion
2009
First posted
Aug 20, 2009
Registry last updated
Aug 20, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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