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

Sponsor

University Hospital, Bordeaux (Other)

Overall Status

Completed

CT.gov ID

NCT00221715

Collaborator

Ministry of Health, France (Other)

100

Enrollment

Arms

106

Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Arteritis Diabetes	Device: femoropopliteal artery bypass Device: femoropopliteal artery bypass	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2002

Actual Primary Completion Date :

May 1, 2011

Actual Study Completion Date :

May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 bypass by autologous saphenous vein	Device: femoropopliteal artery bypass Bypass by autologous saphenous vein
Active Comparator: 2 bypass by dacron or PTFE Prosthesis	Device: femoropopliteal artery bypass bypass by dacron or PTFE Prosthesis

Arm

Intervention/Treatment

Experimental: 1

bypass by autologous saphenous vein

Device: femoropopliteal artery bypass

Bypass by autologous saphenous vein

Active Comparator: 2

bypass by dacron or PTFE Prosthesis

Device: femoropopliteal artery bypass

bypass by dacron or PTFE Prosthesis

Outcome Measures

Primary Outcome Measures

Bypass permeability 5 years after surgery, assessed trough Doppler ultrasonography [5 years]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University Hospital, Bordeaux
Ministry of Health, France

Investigators

Principal Investigator: Dominique Midy, Professor, University Hospital, Bordeaux
Study Chair: Geneviève Chêne, Professor, University Hospital, Bordeaux