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

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00221715
First received: September 13, 2005
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

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 Intervention
Arteritis
Diabetes
 Device: femoropopliteal artery bypass

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Randomised Study Comparing Prosthesis and Autologous Vein for Revascularisation With Above Knee Femoropopliteal Bypass.

Resource links provided by NLM:

MedlinePlus related topics: Diabetes
U.S. FDA Resources

Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • Bypass permeability 5 years after surgery, assessed trough Doppler ultrasonography [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mortality [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Morbidity [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • permeability predictive factors (smoking habits, diabetes, hyperlipidemia, bypass diameter) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Primary and secondary permeability [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • leg salvage [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: July 2002
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00221715

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
  More Information

No publications provided

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT00221715     History of Changes
Other Study ID Numbers: 9248-01, 2000-006
Study First Received: September 13, 2005
Last Updated: May 7, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:
arteritis
lower limb ischemia
femoropopliteal artery bypass
blood vessel prothesis implantation
saphenous vein
 vascular permeability
doppler ultrasonography
randomized clinical trials
efficacy study

Additional relevant MeSH terms:
Arteritis
Vascular Diseases
Cardiovascular Diseases
Vasculitis

ClinicalTrials.gov processed this record on May 21, 2013