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

This study has been completed.
Sponsor:
Collaborator:
B. Braun Melsungen AG
Information provided by:
University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT00300690
First received: March 8, 2006
Last updated: NA
Last verified: March 2006
History: No changes posted
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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).

Further study details as provided by University Hospital, Gentofte, Copenhagen:

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

Estimated Enrollment: 400
Study Start Date: October 1993
Estimated Study Completion Date: January 1999
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00300690

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

No publications provided

ClinicalTrials.gov Identifier: NCT00300690     History of Changes
Other Study ID Numbers: C124
Study First Received: March 8, 2006
Last Updated: March 8, 2006
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

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

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

ClinicalTrials.gov processed this record on October 21, 2014