Endarterectomy Versus Stenting in Patients With Symptomatic Severe Carotid Stenosis - 2
ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier St Anne
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient age 18 years or over
Hemispheric or retinal transient ischemic attack or a non-disabling stroke (or retinal infarct) within 15 days before enrolment
Stenosis of 50% to 99% in the symptomatic carotid artery (NASCET method) for whom revascularisation is decided according to guidelines
Disqualifiers
Patients unwilling or unable to participate in follow-up for whatever reason
Preexisting disability (Modified Rankin Score ≥ 3)
Nonatherosclerotic carotid disease
Severe tandem lesions
Trial design
Design model
Parallel
Treatments tested in this trial
carotid endarterectomy
Procedure/SurgeryCarotid 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
Procedure/SurgeryCarotid 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.
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup A: surgical armActive comparator 1 intervention
Group B: Stenting armActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 procedureSecondary outcomes
1
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 procedure2
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 procedure3
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 procedure4
Stroke/Mortality
Clinical endpoint : proportion of patients having any stroke or death during periprocedural period.
Time frame
From randomization to 30 days after procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Centre Hospitalier St Anne
Lead sponsor
Direction Générale de l'Offre de Soins
Collaborator
Source ClinicalTrials.gov