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

Study Overview
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Brief Summary
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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
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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

Official Title
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Randomised Study Comparing Prosthesis and Autologous Vein for Revascularisation With Above Knee Femoropopliteal Bypass.

Conditions
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Arteritis, Diabetes

Intervention / Treatment
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* Device: femoropopliteal artery bypass
* Device: femoropopliteal artery bypass


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>bypass by autologous saphenous vein | Device: femoropopliteal artery bypass<br>* Bypass by autologous saphenous vein<br>|
| Active Comparator: 2<br>bypass by dacron or PTFE Prosthesis | Device: femoropopliteal artery bypass<br>* bypass by dacron or PTFE Prosthesis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bypass permeability 5 years after surgery, assessed trough Doppler ultrasonography |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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arteritis, lower limb ischemia, femoropopliteal artery bypass, blood vessel prothesis implantation, saphenous vein, vascular permeability, doppler ultrasonography, randomized clinical trials, efficacy study