TREC - Evaluation of the Impact of Eversion Technical Features on the Rate of Carotid Restenosis

NCT06272305 | Not Yet Recruiting

• 1 other identifier: 49RC21_0301
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

Restenosis due to myo-intimal hyperplasia remains a concern after carotid endarterectomy. It occurs in around 6% of cases. Several risk factors for restenosis have already been identified, such as smoking, hypertension, female gender, diabetes, dyslipidemia and small carotid diameter. The main objective of this prospective multicenter study was to determine whether the technical characteristics of the eversion technique have an influence on the rate of restenosis at 1 year. Between September 2021 and November 2022, we followed all patients undergoing carotid endarterectomy by eversion in 8 French hospitals. Demographic data, operative indications and technical characteristics of the endarterectomies performed were collected. These were defined by the circumferential nature of the carotid bulb according to 3 types (TREC A, B or C), and the length and depth of the endarterectomy according to anatomopathological reports. Post-operative complications were collected as much as doppler ultrasonography at three months and 1 year to quantify restenosis.

Conditions

Hyperplasia

Outcome Measures

Primary Outcomes (1)

• Rate of restenosis

  The main objective is to evaluate the rate of restenosis at doppler(defined as restenosis ≥50%(NASCET/ECST)) occurring at one year, according to the technical characteristics of the eversion. They are defined according to three distinct criteria: the circumferential nature of the endarterectomy at the level of the carotid bifurcation, the length of the endarterectomy and its depth in the plane of the intima.

  one year

Secondary Outcomes (3)

• Morbidity and mortality rate

  30 days

• Major cardiological event

  one year

• Minor neurological events

  one year

Interventions

This research does not require any specific investigation and does not imply any modification of treatment. PROCEDURE

Collection of data from the medical record for patients with a non specific carotid endarterectomy

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

Any patient who is having carotid endarterectomy by eversion

You may qualify if:

• Any patient who is having carotid endarterectomy by eversion according to HAS + ESVS recommendations :
• Stenosis \> 70% on dopplerin the absence of neurological symptoms attributable to the carotid territory affected by the stenotic artery.
• Stenosis \> 50% with neurological symptoms attributable to the carotid territory affected by the stenotic artery.

You may not qualify if:

• Any carotid revascularization technique other than eversion (carotid endarterectomy with patch, carotid resection-anastomosis or bypass).
• Cardiac surgery combined with carotid surgery
• Minor patients
• Endovascular carotid surgery
• Opposition to use patient's data

Sponsors & Collaborators

• University Hospital, Angers: lead

MeSH Terms

Conditions

Hyperplasia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gautier HAUPERT, Dr

  university hospital of Angers

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gautier HAUPERT, Dr

CONTACT

02 41 35 38 38; gautier.haupert@chu-angers.fr

Elise HOUSSIN

CONTACT

02 41 35 61 47; elise.houssin@chu-angers.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research and Innovation Director

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: February 22, 2024
• Study Start: March 1, 2024
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share