TREC - Evaluation of the Impact of Eversion Technical Features on the Rate of Carotid Restenosis
- Conditions
- Hyperplasia
- Registration Number
- NCT06272305
- Lead Sponsor
- University Hospital, Angers
- 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
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 500
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.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of restenosis one year 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.
- Secondary Outcome Measures
Name Time Method Morbidity and mortality rate 30 days 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)Major cardiological event one year Major cardiological event defined by troponin elevation with chest pain (or equivalent symptom) and/or ECG changes in favor of myocardial ischemia
Minor neurological events one year Minor neurological events: peripheral neurological and/or cranial nerve damage (tongue deviation, dysphonia, swallowing disorder).