Comparison of Two Under Knee Lower Limb Bypass Types:Endothelialised Prosthesis Versus Autologous Vein Graft

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00221806
Recruitment Status : Unknown
Verified September 2005 by University Hospital, Bordeaux.
Recruitment status was:  Recruiting
First Posted : September 22, 2005
Last Update Posted : September 22, 2005
Ministry of Health, France
W.L.Gore & Associates
Information provided by:
University Hospital, Bordeaux

Brief Summary:
The aim of this project is to improve the hemocompatibility of vascular prosthesis with a complete covering of its endoluminal surface with autologous endothelial cells. The objective is to obtain a better bypass permeability with arterial prosthesis replacing low diameter vessels in lower limbs

Condition or disease Intervention/treatment Phase
Arteritis Device: endothelialised prosthesis Phase 2

Detailed Description:

Physiological vascular endothelium is an hemocompatible and thrombus resistant surface and none of the materials used for revascularisation owns these properties. The aim of this project is to improve the hemocompatibility of vascular prosthesis with a complete covering of their endoluminal surface with autologous endothelial cells. This strategy, that plans to associate an artificial component of synthetic origin and cellular component is a bioartificial vascular substitute concept. First results obtained by an austrian team are really encouraging (with more than 100 patients during last 10 years). Thus, the main objective of this study is to compare efficacy in terms of grafts with endothelialised PTFE prosthesis with great saphenous autologous vein graft for under knee arterial popliteal revascularisation of lower limbs.

This is a phase III, randomised equivalent trial. It is open labelled, with 2 parallel well balanced groups. Forty patients will be randomised. A short segment of the cephalic vein will be cut and some blood will be sampled in patients randomised in the ePTFE group. Endothelial cells of the cephalic vein will be isolated, cultured, with autologous serum, and then amplified before sowing of the internal face of PTFE prosthesis, previously covered with a biological glue clinically validated. Before prosthesis implantation, systematic quality controls will be performed. Implantation will be planned 3 weeks after venous sampling. Eventual failure of cellular culture or prosthesis covering will lead to an autologous vein graft. People randomised in the second group will receive an autologous saphenous vein graft.

The primary outcome is to demonstrate the equivalence of time dependent permeability rate between endothelialized PTFE and autologous vein graft. Equivalence between both technics would allow to preserve autologous saphenous vein for later distal bypasses (where it is the best technic) or for coronary bypasses.

Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomised Study Comparing Endothelialised Prosthesis and Autologous Vein for Under Knee Revascularisation With Femoro Popliteal Bypass. ePTFE
Study Start Date : June 2004
Study Completion Date : June 2012

Primary Outcome Measures :
  1. Bypass permeability during 5 years after surgery, assessed trough Doppler echography

Secondary Outcome Measures :
  1. Mortality and morbidity, primary and secondary permeability, quality of life, leg salvage, cost/benefit ratio.. All patients will be followed up at 1, 3, 6, and 12 months and each year during 5 years

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Age above 18, male or female, II to IV arteritis level with intermittent limping, under knee femoro popliteal bypass indication.

Available saphenous vein, no major trophic trouble, no contra indication to the use of prosthesis.

Exclusion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00221806

Service de chirurgie vasculaire, Hôpital Pellegrin, Place Amélie Raba Léon Recruiting
Bordeaux, France, 33076
Contact: Dominique Midy, MD    +33 55679 5526   
Contact: Laurence Bordenaave, MD-PhD    +33 557656565   
Principal Investigator: Dominique Midy, MD         
Sponsors and Collaborators
University Hospital, Bordeaux
Ministry of Health, France
W.L.Gore & Associates
Study Director: Laurence Bordenave, MD-PhD Institut National de la Santé Et de la Recherche Médicale, France
Study Chair: Jacques Demotes-Mainard, MD-PhD CIC INSERM-CHU de Bordeaux Identifier: NCT00221806     History of Changes
Other Study ID Numbers: 9256-01
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: September 22, 2005
Last Verified: September 2005

Keywords provided by University Hospital, Bordeaux:
Arteritis, femoro popliteal bypass, endothelialised prosthesis, saphenous vein graft, permeability, Doppler echography

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases