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

Diabetes Clinical Trial

— REVA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00221715
• Other study ID #: 9248-01
• Secondary ID: 2000-006
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: May 7, 2013
• Start date: July 2002
• Est. completion date: May 2011

Study information

• Verified date: May 2013
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arteritis
• Diabetes

Intervention

Device:
• femoropopliteal artery bypass
Bypass by autologous saphenous vein
• femoropopliteal artery bypass
bypass by dacron or PTFE Prosthesis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	Ministry of Health, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bypass permeability 5 years after surgery, assessed trough Doppler ultrasonography		5 years	No
Secondary	Mortality		5 years	Yes
Secondary	Morbidity		5 years	Yes
Secondary	permeability predictive factors (smoking habits, diabetes, hyperlipidemia, bypass diameter)		5 years	No
Secondary	Primary and secondary permeability		5 years	No
Secondary	leg salvage		5 years	No