Prospective Evaluation of Femoral Tripod Eversion Technique

Completed

• Conditions: Atheromatous

• Registration Number: NCT03357185
• Lead Sponsor: Hôpital NOVO

Brief 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.

Study Timeline

• Study Start: 2014-06-01
• Primary Completion: 2016-04-30
• Study Completion: 2017-09-30
• Study First Submitted: 2017-11-24
• Study First Submitted QC: 2017-11-24
• Study First Posted: 2017-11-29
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-26
• Last Update Posted: 2019-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

• Age>18 years
• Lower limb atheromatous occlusive disease.
• Stage 2 to 4 according to Rutherford's classification

Exclusion Criteria

• Age< 18
• Previous surgery or endovascular treatment of the ipsilateral limb
• Non atheromatous disease
• Pregnancy
• Life-expectancy estimated to be less than one year

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical follow-up	One year.	Observation of the clinical and life-threatening status of the participants twelve months after the operation. From a general point of view observation of clinical improvement according to Rutherford classification.

Secondary Outcome Measures

Name	Time	Method
Clinical complications	At one month, six months and twelve months.	Clinical follow-up and echo-Doppler was obtained at one month, six months and twelve months.