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

NCT ID: NCT00693823

Last Updated: 2008-06-09

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

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2008-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Atherosclerosis Lower Extremity Ischemia Claudication Rest Pain

Keywords

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atherosclerosis stent angioplasty covered stent

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Femoral-popliteal surgical bypass with prosthetic graft

Group Type ACTIVE_COMPARATOR

Femoral-popliteal Bypass

Intervention Type PROCEDURE

Surgical placement of a prosthetic graft in the thigh from the groin to the knee

2

Interventional angioplasty and placement of an ePTFE covered stent graft within the femoral-popliteal artery as an endoluminal bypass percutaneously

Group Type ACTIVE_COMPARATOR

Angioplasty and stent placement with Viabahn covered stent-graft(W.L. Gore & Associates, Flagstff, Arizona) of superficial femoral artery

Intervention Type DEVICE

Placement of an ePTFE covered stent graft within the superficial femoral artery in the thigh through a needle hole percutaneously

Interventions

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Femoral-popliteal Bypass

Surgical placement of a prosthetic graft in the thigh from the groin to the knee

Intervention Type PROCEDURE

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

Intervention Type DEVICE

Other Intervention Names

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Viabahn endoprosthesis

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

\-
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

Locations

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Baylor University Medical Center

Dallas, Texas, United States

Site Status

Countries

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United States

References

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Lammer J, Dake MD, Bleyn J, Katzen BT, Cejna M, Piquet P, Becker GJ, Settlage RA. Peripheral arterial obstruction: prospective study of treatment with a transluminally placed self-expanding stent-graft. International Trial Study Group. Radiology. 2000 Oct;217(1):95-104. doi: 10.1148/radiology.217.1.r00se0595.

Reference Type BACKGROUND
PMID: 11012429 (View on PubMed)

Hartung O, Otero A, Dubuc M, Boufi M, Barthelemy P, Aissi K, Alimi YS. Efficacy of Hemobahn in the treatment of superficial femoral artery lesions in patients with acute or critical ischemia: a comparative study with claudicants. Eur J Vasc Endovasc Surg. 2005 Sep;30(3):300-6. doi: 10.1016/j.ejvs.2005.04.027.

Reference Type BACKGROUND
PMID: 15936230 (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)

Other Identifiers

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003-179, Viabahn #1

Identifier Type: -

Identifier Source: org_study_id