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

NCT07054060 | Recruiting DMC

• 3 other identifiers: D24-P001PHRC-22-01212024-A01377-40
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke

Keywords

CEA, CAS; stroke; Magnetic resonance imaging; Carotid Artery Stenting; Carotid Endarterectomy

Outcome Measures

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.

  From 3 days before procedure to 7 days after procedure

Secondary Outcomes (15)

• Profile of lesions

  From 3 days before procedure to 7 days after procedure

• Vessel Occlusion Profile

  From 3 days before procedure to 7 days after procedure

• Hemorrhage

  From 3 days before procedure to 7 days after procedure

• Stroke/Mortality

  From randomization to 30 days after procedure

• Stroke Incidence Rate

  From randomization to 30 days after procedure

Study Arms (2)

surgical arm

ACTIVE COMPARATOR

carotid endarterectomy

Procedure: carotid endarterectomy

Stenting arm

ACTIVE COMPARATOR

Carotid artery stenting

Procedure: Carotid artery stenting

Interventions

carotid endarterectomy 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.

surgical arm

Carotid artery stenting 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.

Stenting arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier St Anne: lead
• Direction Générale de l'Offre de Soins: collaborator

Study Sites (1)

Centre hospitalier Sainte-Anne

Paris, 75014, France

RECRUITING

MeSH Terms

Conditions

Stroke; Apraxias

Interventions

Endarterectomy, Carotid

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endarterectomy; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative

Study Officials

• David Calvet, Professor

  GHU Sainte-Anne, PARIS

  STUDY DIRECTOR

• Benjamin GORY, Professor

  CHU NANCY

  STUDY DIRECTOR

• Antoine MILLON, Professor

  Hospices Civils de Lyon

  STUDY DIRECTOR

Central Study Contacts

David Calvet, Professor

CONTACT

+33145658634; d.calvet@ghu-paris.fr

DRCI DRCI

CONTACT

info-recherche@ghu-paris.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: July 8, 2025
• Study Start: July 16, 2025
• Primary Completion (Estimated): March 16, 2028
• Study Completion (Estimated): March 16, 2028
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• 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.

Locations

FR (1)