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NCT03772821: PROFA

Development of a Predictive Score for Local Complications of Femoral Bifurcation Surgery

Terminated Last updated 1 July 2024
What this trial tests

trial testing Data collection in Femoral Bifurcation Surgery in 163 participants. Terminated before completion.

Timeline
8 January 2019
Primary endpoint
2 March 2020
2 March 2020

Quick facts

Lead sponsorCentre Hospitalier Universitaire Dijon
StatusTerminated
Study typeOBSERVATIONAL
Enrollment163
Start date8 January 2019
Primary completion2 March 2020
Estimated completion2 March 2020
Sites7 locations across France

Drugs / interventions tested

Conditions studied

Sponsor

Centre Hospitalier Universitaire Dijon

Who can join

18 and older, any sex, with Femoral Bifurcation Surgery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

No prospective study has yet evaluated the factors influencing the complications of femoral bifurcation surgery in France. Daily practice of investigators suggests that conventional surgical treatment has had a higher rate of local complications in recent years for a variety of reasons that remain to be assessed (aging, overweight, chronic renal failure, diabetes, or other), but as of yet, investigators do not have proof of such an effect. The proposed study would follow a prospective, continuous, multicentre cohort of patients to describe the type, frequency and factors that contribute to local and general complications of surgery on the femoral bifurcation. This information is essential in the choice of the best revascularization technique for the femoral artery, which is frequently the site used for interventions in vascular conditions. Surgeries will be performed in the normal manner. The research will be based on medical data collected during patient management. A measurement of the incision/scar will be taken once the procedure has been performed, either immediately after surgery or after a period of time, during post-operative consultation. Participation in this research will last 3 months from the day of the intervention.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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