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

September 13, 2005
May 7, 2013
July 2002
May 2011   (final data collection date for primary outcome measure)
Bypass permeability 5 years after surgery, assessed trough Doppler ultrasonography [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Bypass permeability 5 years after surgery, assessed trough Doppler ultrasonography
Complete list of historical versions of study NCT00221715 on ClinicalTrials.gov Archive Site
  • 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 ]
  • - Mortality
  • - Morbidity
  • - permeability predictive factors (smoking habits, diabetes, hyperlipidemia, bypass diameter)
  • - primary and secondary permeability
  • - leg salvage
Not Provided
Not Provided
 
Comparison of Two Lower Limb Bypass Types : Prosthesis Versus Autologous Vein
Randomised Study Comparing Prosthesis and Autologous Vein for Revascularisation With Above Knee Femoropopliteal Bypass.

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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Arteritis
  • Diabetes
  • Device: femoropopliteal artery bypass
    Bypass by autologous saphenous vein
  • Device: femoropopliteal artery bypass
    bypass by dacron or PTFE Prosthesis
  • Experimental: 1
    bypass by autologous saphenous vein
    Intervention: Device: femoropopliteal artery bypass
  • Active Comparator: 2
    bypass by dacron or PTFE Prosthesis
    Intervention: Device: femoropopliteal artery bypass
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
May 2011
May 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00221715
9248-01, 2000-006
Yes
University Hospital, Bordeaux
University Hospital, Bordeaux
Ministry of Health, France
Principal Investigator: Dominique Midy, Professor University Hospital, Bordeaux
Study Chair: Geneviève Chêne, Professor University Hospital, Bordeaux
University Hospital, Bordeaux
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP