Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 2:00 AM
Study NCT ID:
NCT06272305
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-22
First Post:
2024-02-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
TREC - Evaluation of the Impact of Eversion Technical Features on the Rate of Carotid Restenosis
Sponsor:
University Hospital, Angers
Organization:
Study Overview
Official Title:
TREC - Evaluation of the Impact of Eversion Technical Features on the Rate of Carotid Restenosis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TREC
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.
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
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: