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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00962897
Other study ID # 009-198, Viabahn #2
Secondary ID
Status Completed
Phase N/A
First received August 19, 2009
Last updated August 19, 2009
Start date September 2003
Est. completion date July 2009

Study information

Verified date August 2009
Source Texas Vascular Associates
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date July 2009
Est. primary completion date May 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Observational Model: Case Control, Time Perspective: Retrospective


Intervention

Procedure:
Femoral-popliteal bypass
Surgical bypass of blockage in the thigh
Stent-graft placement
Patients that underwent treatment of blockage in the thigh arteries with balloon angioplasty with stent-graft placement.

Locations

Country Name City State
United States Texas Vascular Associates Dallas Texas

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

References & Publications (4)

Alimi YS, Hakam Z, Hartung O, Boufi M, Barthèlemy 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. Epub 2007 Nov 5. — View 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. — View Citation

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( — View Citation

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, — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Primary artery/graft patency 48 months No
Secondary Secondary artery/graft patency 48 months No
Secondary Limb salvage 48 months No
Secondary Improvement of lower extremity ischemic symptoms 48 months No
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