Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00221715
Status:
COMPLETED
Last Update Posted:
2013-05-09
First Post:
2005-09-13
Brief Title:
Comparison of Two Lower Limb Bypass Types Prosthesis Versus Autologous Vein
Sponsor:
University Hospital Bordeaux
Organization:
University Hospital Bordeaux
Study Overview
Official Title:
Randomised Study Comparing Prosthesis and Autologous Vein for Revascularisation With Above Knee Femoropopliteal Bypass
Status:
COMPLETED
Status Verified Date:
2013-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REVA
Brief Summary:
When medical treatments fail critical ischemia of the lower limb often leads to surgery ie 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
Detailed Description:
When medical treatments fail critical ischemia of the lower limb often leads to surgery ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2000-006 | None | None | None |