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

NCT ID: NCT06272305

Last Updated: 2024-02-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2024-06-01

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.

Detailed Description

Before the surgery, the following data is collected :

• General data: Sex, age, weight, height
• History and cardiovascular risk factors: diabetes, high blood pressure, dyslipidemia, smoking, chronic renal failure, etc.
• Current treatments taken by the patient
• The degree of initial stenosis of the carotid artery of interest on duplex ultrasound as well as on CT angiography
• The context of endarterectomy if it occurs following a stroke or preventively.

Data to be recovered post-operatively from carotid surgery :

• The operative report specifying the circumferential nature of the carotid endarterectomy on the common carotid-external carotid axis.

3 possible categories: no endarterectomy, non-circumferential partial endarterectomy, circumferential endarterectomy.

• Post-operative doppler (< 1 month) assessing the presence of residual stenosis.
• The patient's operative consequences with the occurrence of intercurrent cardiological events (cardiological, biological or electrocardiographic), neurological (central or peripheral), post-operative complications such as cervical hematoma.

Visit between month 1 and month 3 :

• The anatomopathological report specifying: Length of the endarterectomy part in millimeters and the depth of the endarterectomy according to the location of the separation plane at the level of the artery wall (deep or superficial intimal plane).
• Doppler assessing the presence of carotid restenosis
• The occurrence of central neurological events that may be related to the endarterectomized carotid artery

Visit at one year :

• Doppler assessing the presence of carotid restenosis
• The occurrence of central neurological events that may be related to the endarterectomized carotid artery

Conditions

Hyperplasia

Study Design

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

Interventions

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

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

• 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

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

Sponsors

University Hospital, Angers

OTHER_GOV

Sponsor Role: lead

Responsible Party

Nicolas RIFFET-VIDAL

Research and Innovation Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gautier HAUPERT, Dr

Role: PRINCIPAL_INVESTIGATOR

university hospital of Angers

Central Contacts

Gautier HAUPERT, Dr

Role: CONTACT

gautier.haupert@chu-angers.fr

02 41 35 38 38

Elise HOUSSIN

Role: CONTACT

elise.houssin@chu-angers.fr

02 41 35 61 47

Other Identifiers

49RC21_0301

Identifier Type: -

Identifier Source: org_study_id