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

A Retrospective Review of Randomized Comparison of Prosthetic Femoropopliteal Bypass Versus Viabahn Endoprosthesis for Treatment of Symptomatic Femoral Artery Occlusion With Four Years Followup

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00962897
Enrollment
100
Registered
2009-08-20
Start date
2003-09-30
Completion date
2009-07-31
Last updated
2009-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis, Claudication, Lower Extremity Ischemia, Rest Pain

Keywords

atherosclerosis, covered stent, percutaneous intervention, stent, angioplasty

Brief summary

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.

Interventions

Surgical bypass of blockage in the thigh

PROCEDUREStent-graft placement

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

Sponsors

W.L.Gore & Associates
CollaboratorINDUSTRY
Texas Vascular Associates
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* NA

Design outcomes

Primary

MeasureTime frame
Primary artery/graft patency48 months

Secondary

MeasureTime frame
Secondary artery/graft patency48 months
Limb salvage48 months
Improvement of lower extremity ischemic symptoms48 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026