Clinical Trials Directory

Trials / Completed

CompletedNCT03357185

Prospective Evaluation of Femoral Tripod Eversion Technique

Status
Completed
Phase
Study type
Observational
Enrollment
37 (actual)
Sponsor
Hôpital NOVO · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Endarteriectomy is considered as the first line treatment of femoral bifurcation atheromatous lesions. Eversion technique, similar to that used for carotid bifurcation, is safe and possible for the majority of the femoral tripod lesions. The major advantage of the eversion technique is the absence of prosthetic material to be performed. However, its use has been scarcely evaluated in the literature to date. This work aims at evaluating the long term safety and the efficacy of eversion femoral technique. Surgical technique was thoroughly described and participants were followed up for two years by serial clinical and doppler US examination.

Detailed description

Femoral bifurcation lesions is one of the most frequent lesion encountered in lower limb atheromatous occlusive disease. Current treatment options consists in femoral endarteriectomy or bypass. More recently, endovascular treatment of femoral tripod lesions has been reported. Inguinal area is prone to postoperative infection in up to 20% of the cases. Hence, the use of synthetic graft puts the participants at risk of dramatic consequences in case of postoperative infection. Besides, long term data are still required to validate the use of endovascular device in this very "surgical" area. The use of the eversion technique is possible in the majority of the lesions and offer the major advantage of open surgery in terms of durability, without the use of synthetic material in case of postoperative infection. The investigators herein report the detailed technique, tips and variations of the eversion technique as well as the clinical follow up in terms of clinical benefit according to Rutherford classification and restenosis evaluated by serial doppler US.

Conditions

Interventions

TypeNameDescription
PROCEDUREFemoral eversionThe purpose of this database is to compile the data of patients followed at the René Dubos Hospital Center with symptomatic lower extremity arterial disease (AOMI) (Rutherford 2 to 5) who were operated on by the femoral tripod eversion technique. The database will include data on the operation, possible complications, clinical course of patients and medical and surgical follow-up.

Timeline

Start date
2014-06-01
Primary completion
2016-04-30
Completion
2017-09-30
First posted
2017-11-29
Last updated
2019-07-29

Source: ClinicalTrials.gov record NCT03357185. Inclusion in this directory is not an endorsement.