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

NCT00693823 | Completed DMC

• 1 other identifier: 003-179, Viabahn #1
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Atherosclerosis; Lower Extremity Ischemia; Claudication; Rest Pain

Keywords

atherosclerosis; stent; angioplasty; covered stent

Outcome Measures

Primary Outcomes (3)

• Primary artery/graft patency

  24 months

• Limb Salvage

  24 months

• Improvement in symptoms of lower extremity Ischemia

  24 Months

Secondary Outcomes (1)

• Secondary artery/graft patency

  24 months

Study Arms (2)

1

ACTIVE COMPARATOR

Femoral-popliteal surgical bypass with prosthetic graft

Procedure: Femoral-popliteal Bypass

2

ACTIVE COMPARATOR

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

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

Interventions

Femoral-popliteal Bypass PROCEDURE

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

1

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

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

Also known as: Viabahn endoprosthesis

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Texas Vascular Associates: lead
• W.L.Gore & Associates: collaborator

Study Sites (1)

Baylor University Medical Center

Dallas, Texas, 75226, United States

Location

Related Publications (3)

• 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.

  PMID: 11012429 BACKGROUND

• 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.

  PMID: 15936230 BACKGROUND

• 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.

  PMID: 16784314 BACKGROUND

MeSH Terms

Conditions

Atherosclerosis; Intermittent Claudication

Interventions

Angioplasty

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 3, 2008
• First Posted: June 9, 2008
• Study Start: September 1, 2003
• Primary Completion: May 1, 2007
• Study Completion: January 1, 2008
• Last Updated: June 9, 2008

Record last verified: 2008-06

Locations

US (1)