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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentral Hospital, Nancy, France

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • endarterectomy

    Procedure/Surgery

    patients treated with intervention endarterectomy plus BMM;

  • stenting

    Procedure/Surgery

    patients treated with intervention stenting plus BMM

  • Control group

    Other intervention

    Patients treated with BMM alone.

Treatment groups

1,440 Participants
are divided into 3 treatment groups
Group A: Control GroupExperimental treatment 1 intervention
Group B: Experimental group endarterectomyExperimental treatment 1 intervention
Group C: Experimental group stentingExperimental treatment 1 intervention

Trial outcomes

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)

Time frame
30 days after procedure and up to 5 years

Secondary outcomes

1

Ipsilateral symptomatic cerebral or retinal infarction

occurance of Ipsilateral symptomatic cerebral infarction after randomization

Time frame
5 years follow-up
2

Any symptomatic ischemic stroke,

Occurance of any symptomatic ischemic stroke

Time frame
5 years follow-up
3

Any symptomatic stroke

Occurrence of symptomatic stroke (ischemic or hemorrhagic),

Time frame
5-year follow-up:
4

Myocardial infarction,

Occurence of myocardial infarction,

Time frame
5 years follow up

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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