Endarterectomy Versus Stenting in Patients With Symptomatic Severe Carotid Stenosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-16

Study Completion Date

2028-03-16

Brief Summary

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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.

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Detailed Description

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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 the difference between groups regarding post-intervention MRI characteristics in terms of ischemic lesion number and size, vessel occlusion and hemorrhagic transformation
* To assess differences between groups with regard to the procedural risks and efficacy (within 30 days after procedure) of

1. any stroke or death
2. any stroke,
3. disabling or fatal stroke
4. death
5. transient ischemic attack
6. myocardial infarction
7. local complication
8. cranial nerve palsy

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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surgical arm

carotid endarterectomy

Group Type ACTIVE_COMPARATOR

carotid endarterectomy

Intervention Type PROCEDURE

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.

Stenting arm

Carotid artery stenting

Group Type ACTIVE_COMPARATOR

Carotid artery stenting

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No