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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00300690
First Posted: March 9, 2006
Last Update Posted: March 9, 2006
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.
Collaborator:
B. Braun Melsungen AG
Information provided by:
University Hospital, Gentofte, Copenhagen
March 8, 2006
March 9, 2006
March 9, 2006
October 1993
Not Provided
Primary uncorrected graft patency after 2 years
Same as current
No Changes Posted
  • - Secondary graft patency after two years
  • - Limb survival after two years
  • - Complication rate perioperatively
Same as current
Not Provided
Not Provided
 
Choice of Material for Above-Knee Femoro-Popliteal Bypass Prosthetic Graft (PopUp)
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).
This trial was designed to challenge the wide held view that polytetrafluoroethylene (PTFE) performs better than Dacron for above knee femoropopliteal bypass.
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
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
  • Intermittent Claudication
  • Critical Limb Ischemia
  • Device: 6 mm Uni-graft® (B-Braun)
  • Device: 6 mm Gore-Tex® (WL Gore)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
January 1999
Not Provided

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00300690
C124
Not Provided
Not Provided
Not Provided
Not Provided
University Hospital, Gentofte, Copenhagen
B. Braun Melsungen AG
Principal Investigator: Torben V Schroeder, Professor Rigshospitalet, Denmark
University Hospital, Gentofte, Copenhagen
March 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP