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

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ClinicalTrials.gov Identifier: NCT00300690
Recruitment Status : Completed
First Posted : March 9, 2006
Last Update Posted : March 9, 2006
Sponsor:
Collaborator:
Information provided by:

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.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Completion Date : January 1999
Arms and Interventions


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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

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 ClinicalTrials.gov identifier (NCT number): NCT00300690


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

ClinicalTrials.gov 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:
Ischemia
Intermittent Claudication
Pathologic Processes
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms