Ireland
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Recruiting Not applicable

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

NCT07054060 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2025-07-16
Last updated
2025-07-24

Condition(s) studied

Stroke

Investigational drug(s) / intervention(s)

carotid endarterectomyCarotid artery stenting

carotid 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.

Carotid 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.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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

Primary outcome measure(s)

  • DWI Lesion Detection Rate — From 3 days before procedure to 7 days after procedure
    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.

Trial sites (1)

FacilityCityRegionStatus
Centre hospitalier Sainte-Anne Paris France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07054060 on ClinicalTrials.gov ↗ ← All trials in France