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Prospective Evaluation of Femoral Tripod Eversion Technique

H

Hôpital NOVO

Status

Completed

Conditions

Atheromatous

Treatments

Procedure: Femoral eversion

Study type

Observational

Funder types

Other

Identifiers

NCT03357185
CHRD0515

Details and patient eligibility

About

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.

Full 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.

Enrollment

37 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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