NCT00221715

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2002

Longer than P75 for not_applicable

Status
completed

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

July 1, 2002

Completed
3.2 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
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

May 9, 2013

Status Verified

May 1, 2013

Enrollment Period

8.8 years

First QC Date

September 13, 2005

Last Update Submit

May 7, 2013

Conditions

ArteritisDiabetes

Keywords

arteritislower limb ischemiafemoropopliteal artery bypassblood vessel prothesis implantationsaphenous veinvascular permeabilitydoppler ultrasonographyrandomized clinical trialsefficacy study

Outcome Measures

Primary Outcomes (1)

  • Bypass permeability 5 years after surgery, assessed trough Doppler ultrasonography

    5 years

Secondary Outcomes (5)

  • Mortality

    5 years

  • Morbidity

    5 years

  • permeability predictive factors (smoking habits, diabetes, hyperlipidemia, bypass diameter)

    5 years

  • Primary and secondary permeability

    5 years

  • leg salvage

    5 years

Study Arms (2)

1

EXPERIMENTAL

bypass by autologous saphenous vein

Device: femoropopliteal artery bypass

2

ACTIVE COMPARATOR

bypass by dacron or PTFE Prosthesis

Device: femoropopliteal artery bypass

Interventions

femoropopliteal artery bypassDEVICE

Bypass by autologous saphenous vein

1

Eligibility Criteria

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

You may qualify if:

  • lower limbs arteritis : II to IV arteritis level, above knee femoro popliteal bypass indication
  • signed informed consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ArteritisDiabetes Mellitus

Condition Hierarchy (Ancestors)

VasculitisVascular DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Dominique Midy, Professor

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

  • Geneviève Chêne, Professor

    University Hospital, Bordeaux

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

July 1, 2002

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

May 9, 2013

Record last verified: 2013-05