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Completed

NCT Number: NCT00300690

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

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

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Key information

Conditions

Intermittent Claudication Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Chronic Disease Chronic Limb-Threatening Ischemia Critical Limb Ischemia Disease Attributes Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

6 mm Uni-graft® (B-Braun)

Device

6 mm Gore-Tex® (WL Gore)

Device

Primary outcomes

  1. Primary uncorrected graft patency after 2 years

Secondary outcomes

  1. - Secondary graft patency after two years

  2. - Limb survival after two years

  3. - Complication rate perioperatively

Sponsors and collaborators

Lead sponsor

University Hospital, Gentofte, Copenhagen

Other

Collaborators

  • B. Braun Melsungen AG

Registry information

Official study 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).

Important dates

Study start
1993
Study completion
1999
First posted
Mar 9, 2006
Registry last updated
Mar 9, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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