Prospective Evaluation of Femoral Tripod Eversion Technique (Eversion)

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.

Study Overview

• Status: Completed
• Conditions: Atheromatous
• Intervention / Treatment: Procedure: Femoral eversion

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 Type: Observational
• Enrollment (Actual): 37

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Register including all patients who have been treated with the femoral eversion technique.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical follow-up	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.	One year.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical complications	Clinical follow-up and echo-Doppler was obtained at one month, six months and twelve months.	At one month, six months and twelve months.

Collaborators and Investigators

• Sponsor: Centre Hospitalier René Dubos
• Investigators: Principal Investigator: Jean-Michel DAVAINE, Centre Hospitalier Rene Dubos

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2014
• Primary Completion (Actual): April 30, 2016
• Study Completion (Actual): September 30, 2017

Study Registration Dates

• First Submitted: November 24, 2017
• First Submitted That Met QC Criteria: November 24, 2017
• First Posted (Actual): November 29, 2017

Study Record Updates

• Last Update Posted (Actual): July 29, 2019
• Last Update Submitted That Met QC Criteria: July 26, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Peripheral arterial disease; Vascular surgery; Open surgery; Femoral bifurcation; Eversion
• Other Study ID Numbers: CHRD0515

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No