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

Primary Purpose

Atherosclerosis, Lower Extremity Ischemia, Claudication

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Femoral-popliteal Bypass
Angioplasty and stent placement with Viabahn covered stent-graft(W.L. Gore & Associates, Flagstff, Arizona) of superficial femoral artery
Sponsored by
Texas Vascular Associates
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atherosclerosis focused on measuring atherosclerosis, stent, angioplasty, covered stent

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:Patients that had atherosclerotic stenotic or occlusive lesions of the superficial femoral artery with no significant aorto-iliac disease. The infra-popliteal segment had to be patent with at least single vessel run-off to the ankle. Patients had to be acceptable surgical candidates in the event they were randomized to the surgical arm.

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Exclusion Criteria:Non-operative candidate,Contraindication to IV contrast use, Planned surgery with venous conduit, previously stented segment of the superficial femoral artery, poorly compliant patient.

-

Sites / Locations

  • Baylor University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Femoral-popliteal surgical bypass with prosthetic graft

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

Outcomes

Primary Outcome Measures

Primary artery/graft patency
Limb Salvage
Improvement in symptoms of lower extremity Ischemia

Secondary Outcome Measures

Secondary artery/graft patency

Full Information

First Posted
June 3, 2008
Last Updated
June 6, 2008
Sponsor
Texas Vascular Associates
Collaborators
W.L.Gore & Associates
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1. Study Identification

Unique Protocol Identification Number
NCT00693823
Brief Title
Comparison of Prosthetic Femoropopliteal Bypass Versus Viabahn Endoprosthesis for Treatment of Symptomatic Femoral Artery Occlusive Disease
Official Title
A Prospective Randomized Comparison of Prosthetic Femoropopliteal Bypass Versus Viabahn Endoprosthesis for Treatment of Symptomatic Superficial Femoral Artery Occlusion
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Texas Vascular Associates
Collaborators
W.L.Gore & Associates

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis, Lower Extremity Ischemia, Claudication, Rest Pain
Keywords
atherosclerosis, stent, angioplasty, covered stent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Femoral-popliteal surgical bypass with prosthetic graft
Arm Title
2
Arm Type
Active Comparator
Arm Description
Interventional angioplasty and placement of an ePTFE covered stent graft within the femoral-popliteal artery as an endoluminal bypass percutaneously
Intervention Type
Procedure
Intervention Name(s)
Femoral-popliteal Bypass
Intervention Description
Surgical placement of a prosthetic graft in the thigh from the groin to the knee
Intervention Type
Device
Intervention Name(s)
Angioplasty and stent placement with Viabahn covered stent-graft(W.L. Gore & Associates, Flagstff, Arizona) of superficial femoral artery
Other Intervention Name(s)
Viabahn endoprosthesis
Intervention Description
Placement of an ePTFE covered stent graft within the superficial femoral artery in the thigh through a needle hole percutaneously
Primary Outcome Measure Information:
Title
Primary artery/graft patency
Time Frame
24 months
Title
Limb Salvage
Time Frame
24 months
Title
Improvement in symptoms of lower extremity Ischemia
Time Frame
24 Months
Secondary Outcome Measure Information:
Title
Secondary artery/graft patency
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:Patients that had atherosclerotic stenotic or occlusive lesions of the superficial femoral artery with no significant aorto-iliac disease. The infra-popliteal segment had to be patent with at least single vessel run-off to the ankle. Patients had to be acceptable surgical candidates in the event they were randomized to the surgical arm. - Exclusion Criteria:Non-operative candidate,Contraindication to IV contrast use, Planned surgery with venous conduit, previously stented segment of the superficial femoral artery, poorly compliant patient. -
Facility Information:
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75226
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11012429
Citation
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.
Results Reference
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PubMed Identifier
15936230
Citation
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.
Results Reference
background
PubMed Identifier
16784314
Citation
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.
Results Reference
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Learn more about this trial

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

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