Choice of Material for Above-Knee Femoro-Popliteal Bypass Prosthetic Graft (PopUp)
March 8, 2006 updated by: University Hospital, Gentofte, Copenhagen
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment
400
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
|
Primary uncorrected graft patency after 2 years
|
Secondary Outcome Measures
Outcome Measure |
|---|
|
- Secondary graft patency after two years
|
|
- Limb survival after two years
|
|
- Complication rate perioperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Torben V Schroeder, Professor, Rigshospitalet, Denmark
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 1993
Study Completion
January 1, 1999
Study Registration Dates
First Submitted
March 8, 2006
First Submitted That Met QC Criteria
March 8, 2006
First Posted (Estimate)
March 9, 2006
Study Record Updates
Last Update Posted (Estimate)
March 9, 2006
Last Update Submitted That Met QC Criteria
March 8, 2006
Last Verified
March 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C124
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.