Prospective Evaluation of Femoral Tripod Eversion Technique

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.

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Key information

Conditions

Atheromatous Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Plaque, Atherosclerotic Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital NOVO

Cergy-Pontoise, 95300, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Femoral eversion

Procedure

The 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.

Primary outcomes

Clinical follow-up

Time frame: 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 outcomes

Clinical complications

Time frame: At one month, six months and twelve months.

Clinical follow-up and echo-Doppler was obtained at one month, six months and twelve months.

Sponsors and collaborators

Lead sponsor

Hôpital NOVO

Other

Registry information

Acronym: Eversion

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2017
First posted: Nov 29, 2017
Registry last updated: Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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