Clinical trial NCT06272305: TREC - Evaluation of the Impact of Eversion Technical Features on the Rate of Carotid Restenosis
Official title: TREC - Evaluation of the Impact of Eversion Technical Features on the Rate of Carotid Restenosis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hyperplasia
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2024-02-22
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient who is having carotid endarterectomy by eversion

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

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

Primary outcomes:
measure: Rate of restenosis
timeFrame: one year
Secondary outcomes:
measure: Morbidity and mortality rate
timeFrame: 30 days
measure: Major cardiological event
timeFrame: one year
measure: Minor neurological events
timeFrame: one year
Other outcomes:
Locations:
Study officials:
affiliation: university hospital of Angers
name: Gautier HAUPERT, Dr
role: PRINCIPAL_INVESTIGATOR
References: