Choice of Material for Above-Knee Femoro-Popliteal Bypass Prosthetic Graft (PopUp)
Primary Purpose
Intermittent Claudication, Critical Limb Ischemia
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
6 mm Uni-graft® (B-Braun)
6 mm Gore-Tex® (WL Gore)
Sponsored by
About this trial
This is an interventional treatment trial for Intermittent Claudication focused on measuring Lower extremity bypass surgery, femoro-popliteal bypass, Dacron material, PTFE material
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
Primary uncorrected graft patency after 2 years
Secondary Outcome Measures
- Secondary graft patency after two years
- Limb survival after two years
- Complication rate perioperatively
Full Information
NCT ID
NCT00300690
First Posted
March 8, 2006
Last Updated
March 8, 2006
Sponsor
University Hospital, Gentofte, Copenhagen
Collaborators
B. Braun Melsungen AG
1. Study Identification
Unique Protocol Identification Number
NCT00300690
Brief Title
Choice of Material for Above-Knee Femoro-Popliteal Bypass Prosthetic Graft (PopUp)
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 Type
Interventional
2. Study Status
Record Verification Date
March 2006
Overall Recruitment Status
Completed
Study Start Date
October 1993 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 1999 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Gentofte, Copenhagen
Collaborators
B. Braun Melsungen AG
4. Oversight
5. Study Description
Brief Summary
This trial was designed to challenge the wide held view that polytetrafluoroethylene (PTFE) performs better than Dacron for above knee femoropopliteal bypass.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intermittent Claudication, Critical Limb Ischemia
Keywords
Lower extremity bypass surgery, femoro-popliteal bypass, Dacron material, PTFE material
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
400 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
6 mm Uni-graft® (B-Braun)
Intervention Type
Device
Intervention Name(s)
6 mm Gore-Tex® (WL Gore)
Primary Outcome Measure Information:
Title
Primary uncorrected graft patency after 2 years
Secondary Outcome Measure Information:
Title
- Secondary graft patency after two years
Title
- Limb survival after two years
Title
- Complication rate perioperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Torben V Schroeder, Professor
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Choice of Material for Above-Knee Femoro-Popliteal Bypass Prosthetic Graft (PopUp)
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