Prospective Evaluation of Femoral Tripod Eversion Technique

NCT ID: NCT03357185

Last Updated: 2019-07-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 37 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-06-01
• Study Completion Date: 2017-09-30

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.

Conditions

Atheromatous

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Femoral eversion

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hôpital NOVO

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Michel DAVAINE

Role: PRINCIPAL_INVESTIGATOR

Hôpital NOVO

Other Identifiers

CHRD0515

Identifier Type: -

Identifier Source: org_study_id