An interventional study of carotid endarterectomy and Carotid artery stenting in Stroke, sponsored by Centre Hospitalier St Anne. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-24.
Sponsored by Centre Hospitalier St Anne · Not applicable, Interventional, and Prevention
Carotid stenosis caused by atherosclerosis is a significant risk factor for ischemic stroke, accounting for up to 15% of all strokes and transient ischemic attacks. Randomized clinical trials (RCTs) have demonstrated the benefits of carotid endarterectomy (CEA) in reducing stroke risk in patients with severe symptomatic carotid stenosis. Carotid artery stenting (CAS) has been developed as an alternative to CEA, offering several potential advantages, such as avoiding local surgical complications. However, unlike CEA, CAS has not been compared to medical therapy in RCTs for symptomatic carotid stenosis.
CEA vs CAS Comparison:
Early RCTs conducted in the 2000s showed that CAS was associated with a higher risk of procedural stroke or death compared to CEA (8.9% vs 5.8%; RR 1.53, 95% CI 1.20-1.96, p=0.0006). However, CAS was found to be as effective as CEA in preventing recurrent ipsilateral strokes up to 10 years after treatment. Interestingly, an ancillary study of the ICSS trial showed that significantly more patients in the CAS group (50%) than in the CEA group (17%) had new ischemic lesions on diffusion-weighted MRI (DWI), suggesting that DWI might serve as a surrogate outcome measure for future carotid intervention trials.
Data Analysis and Recent Advances:
Individual pooled data analysis of RCTs indicated that CAS could be as safe and effective as CEA in patients under 70 years old. Recent advances in CAS technology, stenting techniques, antiplatelet therapy, and pre-treatment imaging have improved the periprocedural safety of CAS. Due to its ability to treat patients soon after a stroke, CAS has become increasingly used in routine clinical practice.
Study Objectives:
The question remains whether CAS is as safe as CEA in patients with recent symptomatic severe carotid stenosis. The study's objectives are:
Primary Objective:
To assess whether carotid stenting is non-inferior to carotid endarterectomy in preventing new ischemic lesions on DWI MRI, confirmed by a core lab.
To assess differences between groups with regard to the procedural risks and efficacy (within 30 days after procedure) of
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 600 is above the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →Centre Hospitalier St Anne is the lead sponsor of 101 studies on the registry; 55 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
carotid endarterectomy
Procedure: carotid endarterectomy
Carotid artery stenting
Procedure: Carotid artery stenting
Carotid endarterectomy is a surgical procedure used to reduce the risk of stroke due to carotid artery stenosis. During an endarterectomy, the surgeon opens the artery and removes the plaque.
Carotid artery stenting is an endovascular procedure in which a stent is deployed in the lumen of the carotid artery to treat narrowing of the carotid artery and reduce the risk of stroke.
DWI Lesion Detection Rate
Imaging endpoint : Proportion of patients having at least one new lesion on post-treatment Diffusion-Weigthed Imaging (DWI) MRI compared to pre-treatment DWI MRI and confirmed by a core lab. The pre-treatment DWI MRI will be performed within 3 days before procedure. The post-treatment DWI MRI will be performed within 7 days after procedure.
Time frame: From 3 days before procedure to 7 days after procedure
Profile of lesions
Imaging endpoint : Number and size of new lesions on post-treatment MRI. The pre-treatment DWI MRI will be performed within 3 days before procedure. The post-treatment DWI MRI will be performed within 7 days after procedure.
Time frame: From 3 days before procedure to 7 days after procedure
Vessel Occlusion Profile
Imaging endpoint : Proportion of patients having a new intracranial vessel occlusion on post-treatment MRI. The pre-treatment DWI MRI will be performed within 3 days before procedure. The post-treatment DWI MRI will be performed within 7 days after procedure.
Time frame: From 3 days before procedure to 7 days after procedure
Hemorrhage
Imaging endpoint : Hemorrhagic transformation on post-treatment MRI. The pre-treatment DWI MRI will be performed within 3 days before procedure. The post-treatment DWI MRI will be performed within 7 days after procedure.
Time frame: From 3 days before procedure to 7 days after procedure
Stroke/Mortality
Clinical endpoint : proportion of patients having any stroke or death during periprocedural period.
Time frame: From randomization to 30 days after procedure
Stroke Incidence Rate
Clinical endpoint : Proportion of patients having any stroke during periprocedural period.
Time frame: From randomization to 30 days after procedure
Severe Stroke Incidence
Clinical endpoint : Proportion of patients having any disabling or fatal stroke during periprocedural period.
Time frame: From randomization to 30 days after procedure
Mortality
Clinical endpoint : Proportion of patients who died during periprocedural period.
Time frame: From randomization to 30 days after procedure
TIA Incidence
Clinical endpoint : Proportion of patients having a Transient ischemic attack during periprocedural period.
Time frame: From randomization to 30 days after procedure
MI Occurrence
Clinical endpoint : Proportion of patients having myocardial infarction during periprocedural period.
Time frame: From randomization to 30 days after procedure
Local complication
Clinical endpoint : cervical or groin or radial hematoma, infection, arteriovenous fistula at puncture site, lower-limb arterial occlusion during periprocedural period.
Time frame: From randomization to 30 days after procedure
Cranial Nerve Injury Events
Clinical endpoint : Proportion of patients having cranial nerve injury during periprocedural period.
Time frame: From randomization to 30 days after procedure
Hospitalization Duration
Healthcare endpoint : number of days the patient stayed in the hospital stay
Time frame: From the date of the carotid artery stenting (CAS) or endarterectomy (CEA) procedure until the date of hospital discharge, assessed up to 30 days
Procedure Delay
Operational endpoint: number of days between the date at which the patient is randomized and the date at which the carotid artery stenting (CAS) or endarterectomy) is proceeded
Time frame: From the date of patient randomization until the date of carotid artery stenting (CAS) or endarterectomy (CEA) procedure, assessed up to 15 days
Ischemic Events
Clinical endpoint: Incidence of ischemic events among patients with confirmed new lesions on post-procedure DWI MRI (as verified by core lab assessment). The pre-treatment DWI MRI will be performed within 3 days before procedure. The post-treatment DWI MRI will be performed within 7 days after procedure.
Time frame: From 3 days before procedure to 7 days after procedure.
Hemorrhage
Imaging endpoint : Hemorrhagic transformation on post-treatment MRI. The pre-treatment DWI MRI will be performed within 3 days before procedure. The post-treatment DWI MRI will be performed within 7 days after procedure.
Time frame: From 3 days before procedure to 7 days after procedure.
Plan to share: Yes — Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared.
Supporting information: Study protocol, Informed consent form
Time frame: Two years after the last publication
Access criteria: Data sharing must be accepted by the sponsor and the PI. Technical feasibility and financial support will be discussed before mandatory contractualization. Processing of shared data must comply with GDPR.
No publications or documents are linked to this record.
Started Jul 2025 (actual). Primary completion is estimated for Mar 2028, 32 months after the start.
Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's planned 32 months is above that.
Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
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