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

Atherosclerosis Clinical Trial

Official title:

A Prospective Randomized Comparison of Prosthetic Femoropopliteal Bypass Versus Viabahn Endoprosthesis for Treatment of Symptomatic Superficial Femoral Artery Occlusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00693823
• Other study ID #: 003-179, Viabahn #1
• Status: Completed
• Phase: N/A
• First received: June 3, 2008
• Last updated: June 6, 2008
• Start date: September 2003
• Est. completion date: January 2008

Study information

• Verified date: June 2008
• Source: Texas Vascular Associates
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: January 2008
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis
• Claudication
• Lower Extremity Ischemia
• Rest Pain

Intervention

Procedure:
• Femoral-popliteal Bypass
Surgical placement of a prosthetic graft in the thigh from the groin to the knee

Device:
• 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

Locations

Country	Name	City	State
United States	Baylor University Medical Center	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Texas Vascular Associates	W.L.Gore & Associates

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary artery/graft patency		24 months	Yes
Primary	Limb Salvage		24 months	No
Primary	Improvement in symptoms of lower extremity Ischemia		24 Months	No
Secondary	Secondary artery/graft patency		24 months	Yes