Comparison of Two Under Knee Lower Limb Bypass Types:Endothelialised Prosthesis Versus Autologous Vein Graft
|ClinicalTrials.gov 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
|First Submitted Date ICMJE||September 13, 2005|
|First Posted Date ICMJE||September 22, 2005|
|Last Update Posted Date||September 22, 2005|
|Start Date ICMJE||June 2004|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Bypass permeability during 5 years after surgery, assessed trough Doppler echography|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE
||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|
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Comparison of Two Under Knee Lower Limb Bypass Types:Endothelialised Prosthesis Versus Autologous Vein Graft|
|Official Title ICMJE||Randomised Study Comparing Endothelialised Prosthesis and Autologous Vein for Under Knee Revascularisation With Femoro Popliteal Bypass. ePTFE|
|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|
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 ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Intervention ICMJE||Device: endothelialised prosthesis|
|Study Arms||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Unknown status|
|Estimated Completion Date||June 2012|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
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.
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||France|
|Removed Location Countries|
|NCT Number ICMJE||NCT00221806|
|Other Study ID Numbers ICMJE||9256-01|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||University Hospital, Bordeaux|
|PRS Account||University Hospital, Bordeaux|
|Verification Date||September 2005|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP