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

Tracking Information

First Received Date ^ICMJE

March 8, 2006

Last Updated Date

March 8, 2006

Start Date ^ICMJE

October 1993

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Primary uncorrected graft patency after 2 years

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

- Secondary graft patency after two years
- Limb survival after two years
- Complication rate perioperatively

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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).

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Intermittent Claudication
Critical Limb Ischemia

Intervention ^ICMJE

Device: 6 mm Uni-graft® (B-Braun)
Device: 6 mm Gore-Tex® (WL Gore)

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

400

Completion Date

January 1999

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00300690

Other Study ID Numbers ^ICMJE

C124

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

University Hospital, Gentofte, Copenhagen

Collaborators ^ICMJE

B. Braun Melsungen AG

Investigators ^ICMJE

Principal Investigator:

Torben V Schroeder, Professor

Rigshospitalet, Denmark

Information Provided By

University Hospital, Gentofte, Copenhagen

Verification Date

March 2006

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

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