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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hyperplasia
• Intervention / Treatment: Procedure: This research does not require any specific investigation and does not imply any modification of treatment.

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

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Gautier HAUPERT, Dr; Phone Number: 02 41 35 38 38; Email: gautier.haupert@chu-angers.fr
• Study Contact Backup: Name: Elise HOUSSIN; Phone Number: 02 41 35 61 47; Email: elise.houssin@chu-angers.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Any patient who is having carotid endarterectomy by eversion

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morbidity and mortality rate	Cumulative morbidity and mortality rate at 30 days defined by: All-cause mortality within 30 days post-op; Major neurological event defined as the occurrence of a stroke (focal signs lasting more than 24 hours, confirmed by brain imaging)	30 days
Major cardiological event	Major cardiological event defined by troponin elevation with chest pain (or equivalent symptom) and/or ECG changes in favor of myocardial ischemia	one year
Minor neurological events	Minor neurological events: peripheral neurological and/or cranial nerve damage (tongue deviation, dysphonia, swallowing disorder).	one year

Collaborators and Investigators

• Sponsor: University Hospital, Angers
• Investigators: Principal Investigator: Gautier HAUPERT, Dr, University hospital of Angers

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: February 15, 2024
• First Submitted That Met QC Criteria: February 15, 2024
• First Posted (Estimated): February 22, 2024

Study Record Updates

• Last Update Posted (Estimated): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hyperplasia
• Other Study ID Numbers: 49RC21_0301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No