Clinical trial NCT00221715: Comparison of Two Lower Limb Bypass Types : Prosthesis Versus Autologous Vein
Official title: Randomised Study Comparing Prosthesis and Autologous Vein for Revascularisation With Above Knee Femoropopliteal Bypass.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arteritis
Diabetes
Keywords: arteritis
lower limb ischemia
femoropopliteal artery bypass
blood vessel prothesis implantation
saphenous vein
vascular permeability
doppler ultrasonography
randomized clinical trials
efficacy study
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2005-09-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Bypass permeability 5 years after surgery, assessed trough Doppler ultrasonography
timeFrame: 5 years
Secondary outcomes:
measure: Mortality
timeFrame: 5 years
measure: Morbidity
timeFrame: 5 years
measure: permeability predictive factors (smoking habits, diabetes, hyperlipidemia, bypass diameter)
timeFrame: 5 years
measure: Primary and secondary permeability
timeFrame: 5 years
measure: leg salvage
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Bordeaux
name: Dominique Midy, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Bordeaux
name: Geneviève Chêne, Professor
role: STUDY_CHAIR
References: