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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
endarterectomy
Procedure/Surgerypatients treated with intervention endarterectomy plus BMM;
stenting
Procedure/Surgerypatients treated with intervention stenting plus BMM
Control group
Other interventionPatients treated with BMM alone.
Treatment groups
Trial outcomes
Primary outcomes
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)
Secondary outcomes
Ipsilateral symptomatic cerebral or retinal infarction
occurance of Ipsilateral symptomatic cerebral infarction after randomization
Any symptomatic ischemic stroke,
Occurance of any symptomatic ischemic stroke
Any symptomatic stroke
Occurrence of symptomatic stroke (ischemic or hemorrhagic),
Myocardial infarction,
Occurence of myocardial infarction,
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: