An interventional study of femoropopliteal artery bypass and femoropopliteal artery bypass in Arteritis and Diabetes, sponsored by University Hospital, Bordeaux. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-10.
Sponsored by University Hospital, Bordeaux · Not applicable, Interventional, and Treatment
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
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
20 studies on the registry are indexed under Arteritis; 3 are open to participants now.
This study's enrollment of 100 is above the median of 64 across 12 interventional studies indexed under Arteritis.
Browse Arteritis studies →University Hospital, Bordeaux is the lead sponsor of 806 studies on the registry; 197 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
bypass by autologous saphenous vein
Device: femoropopliteal artery bypass
bypass by dacron or PTFE Prosthesis
Device: femoropopliteal artery bypass
Bypass by autologous saphenous vein
bypass by dacron or PTFE Prosthesis
Bypass permeability 5 years after surgery, assessed trough Doppler ultrasonography
Time frame: 5 years
Mortality
Time frame: 5 years
Morbidity
Time frame: 5 years
permeability predictive factors (smoking habits, diabetes, hyperlipidemia, bypass diameter)
Time frame: 5 years
Primary and secondary permeability
Time frame: 5 years
leg salvage
Time frame: 5 years
The record gives a start of Jul 2002, a primary completion of May 2011 and a completion of May 2011. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.
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