Comparison of Two Lower Limb Bypass Types : Prosthesis Versus Autologous Vein

Not Applicable

Completed

• Conditions: Arteritis; Diabetes
• Interventions: Device: femoropopliteal artery bypass

• Registration Number: NCT00221715
• Lead Sponsor: University Hospital, Bordeaux

Brief Summary

When medical treatments fail, critical ischemia of the lower limb often leads to surgery, i.e. above knee femoro popliteal bypass. This bypass can be performed either with DACRON or PTFE prosthesis or with the autologous saphenous vein. Both technics are used but they have not been compared regarding bypass permeability and limb salvage. Thus, this study will compare the permeability rate of above knee femoro popliteal surgery whether performed with autologous vein versus prosthesis

Detailed Description

When medical treatments fail, critical ischemia of the lower limb often leads to surgery, i.e. above knee femoro popliteal bypass. This bypass can be performed with either DACRON or PTFE prosthesis or with the autologous saphenous vein. The principle disadvantages of prosthesis are their prejudged worse permeability and the risk of infection. Too few reliable randomised, multicentric studies in this indication comparing vein bypasses versus prosthesis bypasses have been conducted to firmly confirm the first argument. Thus, the purpose of this multicentric, randomised, national study is to compare, 5 years after surgery, the permeability rate of above knee femoropopliteal bypass with vein versus prosthesis. Primary and secondary permeability, permeability predictive factors, and leg salvage rate will also be assessed. One hundred enrolled patients with II to IV level leg arteritis will randomly be assigned to one of the surgery groups : vein or prosthesis (50 each). The recruiting period will last 3 years and a half, and the follow up 5 years for each patient. The main primary outcome, bypass permeability, will be assessed through Doppler ultrasonography during five years. Secondary endpoints, mortality and morbidity, will be evaluated during the clinical follow up. Permeability predictive factors, primary and secondary permeability, leg salvage will also be recorded. If the permeability rates are equivalent between prosthesis and vein, the use of prosthesis will be preferred as this surgery is easier and faster, and as it is important that the vein remains available for distal revascularisation (where it is more efficient) and for revascularisation of coronary arteries

Study Timeline

• Study Start: 2002-07
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-22
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-07
• Last Update Posted: 2013-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• lower limbs arteritis : II to IV arteritis level, above knee femoro popliteal bypass indication
• signed informed consent

Exclusion Criteria

• no contra indication to the use of prosthesis
• Available saphenous vein
• no major trophic trouble

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	femoropopliteal artery bypass	bypass by autologous saphenous vein
2	femoropopliteal artery bypass	bypass by dacron or PTFE Prosthesis

Primary Outcome Measures

Name	Time	Method
Bypass permeability 5 years after surgery, assessed trough Doppler ultrasonography	5 years

Secondary Outcome Measures

Name	Time	Method
Mortality	5 years
Morbidity	5 years
permeability predictive factors (smoking habits, diabetes, hyperlipidemia, bypass diameter)	5 years
Primary and secondary permeability	5 years
leg salvage	5 years