Prospective Evaluation of Femoral Tripod Eversion Technique

NCT03357185 | Completed

• 1 other identifier: CHRD0515
• Study Type: observational
• Target: 37
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Atheromatous

Keywords

Femoral bifurcation; Peripheral arterial disease; Vascular surgery; Eversion; Open surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Clinical complications

  At one month, six months and twelve months.

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hôpital NOVO: lead

MeSH Terms

Conditions

Plaque, Atherosclerotic; Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Jean-Michel DAVAINE

  Hôpital NOVO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2017
• First Posted: November 29, 2017
• Study Start: June 1, 2014
• Primary Completion: April 30, 2016
• Study Completion: September 30, 2017
• Last Updated: July 29, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share