Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06272305
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-22
First Post:
2024-02-15
Brief Title:
TREC - Evaluation of the Impact of Eversion Technical Features on the Rate of Carotid Restenosis
Sponsor:
University Hospital Angers
Organization:
University Hospital Angers
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 patients 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 patients 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:
None
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?:
None