RecruitingNot ApplicableNCT07054060

Endarterectomy Versus Stenting in Patients With Symptomatic Severe Carotid Stenosis - 2

Sponsor

Centre Hospitalier St Anne

Enrollment

600 participants

Start Date

Jul 16, 2025

Study Type

INTERVENTIONAL

Conditions

Stroke

Summary

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

Min Age: 18 Years

Inclusion Criteria3

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

Exclusion Criteria12

Patients unwilling or unable to participate in follow-up for whatever reason
Preexisting disability (Modified Rankin Score ≥ 3)
Nonatherosclerotic carotid disease
Severe tandem lesions
Previous revascularization of the symptomatic carotid stenosis
History of bleeding disorder
Unstable angina
Contraindication to dual antiplatelet therapy
Contraindication to MRI
Life expectancy of less than 2 years
Percutaneaous or surgical intervention within 30 days before or after the study procedure
Stenotic lesion on arterial workup appeared as not a factor in the selection

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREcarotid endarterectomy

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.

PROCEDURECarotid artery stenting

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.