NCT00221806

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2004

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
6.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

September 22, 2005

Status Verified

September 1, 2005

First QC Date

September 13, 2005

Last Update Submit

September 13, 2005

Conditions

Arteritis

Keywords

Arteritis, femoro popliteal bypass, endothelialised prosthesis, saphenous vein graft, permeability, Doppler echography

Outcome Measures

Primary Outcomes (1)

  • Bypass permeability during 5 years after surgery, assessed trough Doppler echography

Secondary Outcomes (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

Interventions

endothelialised prosthesisDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de chirurgie vasculaire, Hôpital Pellegrin, Place Amélie Raba Léon

Bordeaux, 33076, France

RECRUITING

MeSH Terms

Conditions

Arteritis

Condition Hierarchy (Ancestors)

VasculitisVascular DiseasesCardiovascular Diseases

Study Officials

  • Laurence Bordenave, MD-PhD

    Institut National de la Santé Et de la Recherche Médicale, France

    STUDY DIRECTOR

  • Jacques Demotes-Mainard, MD-PhD

    CIC INSERM-CHU de Bordeaux

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

June 1, 2004

Study Completion

June 1, 2012

Last Updated

September 22, 2005

Record last verified: 2005-09

Locations

FR(1)