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Choice of Material for Above-Knee Femoro-Popliteal Bypass Prosthetic Graft (PopUp)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00300690
Recruitment Status : Completed
First Posted : March 9, 2006
Last Update Posted : March 9, 2006
B. Braun Melsungen AG
Information provided by:
University Hospital, Gentofte, Copenhagen

Brief Summary:
This trial was designed to challenge the wide held view that polytetrafluoroethylene (PTFE) performs better than Dacron for above knee femoropopliteal bypass.

Condition or disease Intervention/treatment Phase
Intermittent Claudication Critical Limb Ischemia Device: 6 mm Uni-graft® (B-Braun) Device: 6 mm Gore-Tex® (WL Gore) Phase 4

Detailed Description:
Objective: To investigate whether patency rates of 6 mm gelatine coated, knitted, double velour polyester prostheses are equal to the 6 mm thinwalled ePTFE prostheses as above-knee femoro-popliteal bypass graft

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Study Type : Interventional  (Clinical Trial)
Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Choice of Material for Above-Knee Femoro-Popliteal Bypass Prosthetic Graft. Multicenter Randomized Study of an Impregnated Knitted Polyester Prosthesis Vs. PTFE (Uni-Graft Vs Gore-Tex).
Study Start Date : October 1993
Study Completion Date : January 1999

Primary Outcome Measures :
  1. Primary uncorrected graft patency after 2 years

Secondary Outcome Measures :
  1. - Secondary graft patency after two years
  2. - Limb survival after two years
  3. - Complication rate perioperatively

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All patients who require revascularisation of the lower extremity suitable for above-knee femoro-popliteal bypass surgery.

Exclusion Criteria:

  • pregnancy
  • No consent to participate in the study
  • Previous enrollment in the study
  • follow-up is not possible

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00300690

Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
B. Braun Melsungen AG
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Principal Investigator: Torben V Schroeder, Professor Rigshospitalet, Denmark

Layout table for additonal information Identifier: NCT00300690     History of Changes
Other Study ID Numbers: C124
First Posted: March 9, 2006    Key Record Dates
Last Update Posted: March 9, 2006
Last Verified: March 2006

Keywords provided by University Hospital, Gentofte, Copenhagen:
Lower extremity bypass surgery
femoro-popliteal bypass
Dacron material
PTFE material

Additional relevant MeSH terms:
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Intermittent Claudication
Pathologic Processes
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms