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

NCT ID: NCT00962897

Last Updated: 2009-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-09-30

Study Completion Date

2009-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Atherosclerosis Lower Extremity Ischemia Claudication Rest Pain

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Surgical Bypass Group

Those patients that underwent bypass of blockage in the thigh with surgery.

Femoral-popliteal bypass

Intervention Type PROCEDURE

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.

Stent-graft placement

Intervention Type PROCEDURE

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

Interventions

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Femoral-popliteal bypass

Surgical bypass of blockage in the thigh

Intervention Type PROCEDURE

Stent-graft placement

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* NA
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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W.L.Gore & Associates

INDUSTRY

Sponsor Role collaborator

Texas Vascular Associates

OTHER

Sponsor Role lead

Responsible Party

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Texas Vascular Associates/Baylor University Medical Center

Principal Investigators

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Dennis R Gable, M.D.

Role: PRINCIPAL_INVESTIGATOR

Texas Vascular Associates

Locations

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Texas Vascular Associates

Dallas, Texas, United States

Site Status

Countries

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United States

References

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Alimi YS, Hakam Z, Hartung O, Boufi M, Barthelemy P, Aissi K, Dubuc M. Efficacy of Viabahn in the treatment of severe superficial femoral artery lesions: which factors influence long-term patency? Eur J Vasc Endovasc Surg. 2008 Mar;35(3):346-52. doi: 10.1016/j.ejvs.2007.09.005. Epub 2007 Nov 5.

Reference Type BACKGROUND
PMID: 17983772 (View on PubMed)

Fischer M, Schwabe C, Schulte KL. Value of the hemobahn/viabahn endoprosthesis in the treatment of long chronic lesions of the superficial femoral artery: 6 years of experience. J Endovasc Ther. 2006 Jun;13(3):281-90. doi: 10.1583/05-1799.1.

Reference Type BACKGROUND
PMID: 16784314 (View on PubMed)

McQuade K, Gable D, Hohman S, Pearl G, Theune B. Randomized comparison of ePTFE/nitinol self-expanding stent graft vs prosthetic femoral-popliteal bypass in the treatment of superficial femoral artery occlusive disease. J Vasc Surg. 2009 Jan;49(1):109-15, 116.e1-9; discussion 116. doi: 10.1016/j.jvs.2008.08.041. Epub 2008 Nov 22.

Reference Type RESULT
PMID: 19028055 (View on PubMed)

Kedora J, Hohmann S, Garrett W, Munschaur C, Theune B, Gable D. Randomized comparison of percutaneous Viabahn stent grafts vs prosthetic femoral-popliteal bypass in the treatment of superficial femoral arterial occlusive disease. J Vasc Surg. 2007 Jan;45(1):10-6; discussion 16. doi: 10.1016/j.jvs.2006.08.074. Epub 2006 Nov 28.

Reference Type RESULT
PMID: 17126520 (View on PubMed)

Other Identifiers

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009-198, Viabahn #2

Identifier Type: -

Identifier Source: org_study_id

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