Determination of the Best Therapeutic Strategy, Interventional With Best Medical Management (BMM) Versus BMM Alone, for Patients With Symptomatic Moderate <70% Atherosclerotic Carotid Artery Stenosis: the SIMCA Multicenter Randomized Trial

NCT07839390 | Not Yet Recruiting DMC

• 2 other identifiers: 2020PI2012023-A01852-43
• Study Type: interventional
• Target: 1,440
• Locations: 0 countries
• Sites: N/A

Brief Summary

Stroke is one of the leading causes of death and the main cause of long-term disability worldwide. A frequent cause is the narrowing of the carotid artery due to atherosclerosis, known as carotid artery stenosis. When stenosis is moderate (\< 70%) and has already caused symptoms, the best strategy to prevent another stroke remains uncertain. Earlier studies compared surgery or stenting with medical therapy, but these trials were conducted before modern medical treatments were available and did not consider important plaque characteristics that may increase the risk of recurrence. As a result, current clinical practice varies widely, and existing guidelines are based on low-quality evidence. The SIMCA trial aims to address this gap by comparing two treatment strategies in patients with symptomatic moderate carotid stenosis : best medical management (BMM) alone versus BMM combined with an intervention (endarterectomy or stenting). The primary objective is To determine whether intervention (endarterectomy or stenting) plus BMM compared to BMM alone significantly reduces the incidence of ipsilateral symptomatic cerebral infarction in patients with symptomatic atherosclerotic moderate stenosis of the cervical internal carotid artery at 5 years Hypothesis : The arm of this study is therefore to determine the best therapeutic strategy between intervention with best medical management (BMM) versus BMM alone (main objective) and the best intervention (endarterectomy or stenting) (secondary objective) to prevent cerebral infarction in patients with symptomatic atherosclerotic moderate (\< 70%) CAS.

Conditions

Carotid Stenosis

Keywords

atherosclerotic Carotid Artery Stenosis (CAS)

Outcome Measures

Primary Outcomes (1)

• Any stroke or death during the periprocedural period, or ipsilateral symptomatic cerebral infarction during long-term follow-up

  * Any stroke or death during the periprocedural period (within 30 days after procedure) * Or symptomatic cerebral or retinal infarction ipsilateral to stenosis during long-term follow-up (5 years)

  30 days after procedure and up to 5 years

Secondary Outcomes (31)

• Ipsilateral symptomatic cerebral or retinal infarction

  5 years follow-up

• Any symptomatic ischemic stroke,

  5 years follow-up

• Any symptomatic stroke

  5-year follow-up:

• Myocardial infarction,

  5 years follow up

• Vascular death,

  5 years follow up

Study Arms (3)

Control Group

EXPERIMENTAL

patients treated with BMM alone

Other: Control group

Experimental group endarterectomy

EXPERIMENTAL

patients treated with intervention endarterectomy plus BMM

Procedure: endarterectomy

Experimental group stenting

EXPERIMENTAL

patients treated with intervention stenting plus BMM

Procedure: stenting

Interventions

endarterectomy PROCEDURE

patients treated with intervention endarterectomy plus BMM;

Experimental group endarterectomy

stenting PROCEDURE

patients treated with intervention stenting plus BMM

Experimental group stenting

Control group OTHER

Patients treated with BMM alone.

Control Group

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years
• Modified Rankin Score 0 to 3
• Atherosclerotic stenosis of the cervical internal carotid artery with
• Between 50-69% (NASCET method) confirmed by computed tomography angiography (CTA) or magnetic resonance angiography (MRA) or digital subtraction angiography (DSA) OR
• Stenosis \< 50% (NASCET method) confirmed by CTA or MRA or DSA with at least one of the following markers of high-risk carotid plaque features for stroke recurrence (vulnerable plaque), possibly identified by doppler ultrasound:
• intra-plaque hemorrhage
• irregular plaque surface defined as an indentation, fissure, erosion, or ulceration on the luminal surface of the plaque
• lipid-rich necrotic core (LRNC) occupying ≥50% plaque4. Symptomatic stenosis defined as clinical signs due to
• ipsilateral ischemic stroke documented on cerebral imaging OR Ipsilateral permanent or transitory retinal embolic infarction document by ophthalmologic examination OR transient ischemic attack defined as transient motor deficit and/or aphasia. AND
• obviously due to the atherosclerotic stenosis: in a concordant territory, excluding lacunar infarction, and associated cardio embolic source (atrial fibrillation excluded by ECG, and 24-hour monitoring or holter), and multiterritorial simultaneous cerebral infarctions AND
• within 14 days before planned intervention
• For whom both kinds of intervention (endarterectomy and stenting) are allowed.
• Able and willing to give consent
• Person affiliated to or beneficiary of a social security plan

You may not qualify if:

• Expected survival \<5 years (renal clairance MDRD \<30 mL/min/1.73m2, severe cardiac or respiratory insufficiency, active cancer)
• Patient unable to undergo any of both carotid revascularization (endarterectomy or stenting)
• Atrial fibrillation or medical history of atrial fibrillation
• Carotid artery stenosis due to radiotherapy
• Tandem lesion defined with the association of a severe intracranial stenosis (degree above the determining cervical internal carotid artery stenosis) or complete occlusion
• History of revascularization procedure on the determining internal carotid artery
• Contra indication to dual antiplatelet therapy
• Person referred in articles L.1121-5, L. 1121-7 and L.1121-8 of the Public Health Code:
• Pregnant, parturient or breastfeeding woman
• Minor person (non-emancipated)
• Adult person under legal protection (any form of public guardianship)
• Person deprived of liberty for judicial or administrative decision, person under psychiatric care as referred in articles L. 3212-1 and L. 3213-1

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

MeSH Terms

Conditions

Carotid Stenosis

Interventions

Endarterectomy; Stents; Control Groups

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prostheses and Implants; Equipment and Supplies; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Sébastien RICHARD, Professor

CONTACT

03 83 85 22 56; s.richard@chru-nancy.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 3-paralell-arms, prospective, multicenter, open randomized trial Control group: patients treated with BMM alone. Experimental group: patients treated with intervention (endarterectomy or stenting) plus BMM.

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: September 24, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2034
• Study Completion (Estimated): March 31, 2035
• Last Updated: September 24, 2026

Record last verified: 2026-09