Carotid Stenosis
Conditions
Keywords
atherosclerotic Carotid Artery Stenosis (CAS)
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.
Interventions
PROCEDUREendarterectomy
patients treated with intervention endarterectomy plus BMM;
PROCEDUREstenting
patients treated with intervention stenting plus BMM
OTHERControl group
Patients treated with BMM alone.
Sponsors
Central Hospital, Nancy, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Any stroke or death during the periprocedural period, or ipsilateral symptomatic cerebral infarction during long-term follow-up | 30 days after procedure and up to 5 years | * 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
| Measure | Time frame | Description |
|---|---|---|
| Ipsilateral symptomatic cerebral or retinal infarction | 5 years follow-up | occurance of Ipsilateral symptomatic cerebral infarction after randomization |
| Any symptomatic ischemic stroke, | 5 years follow-up | Occurance of any symptomatic ischemic stroke |
| Any symptomatic stroke | 5-year follow-up: | Occurrence of symptomatic stroke (ischemic or hemorrhagic), |
| Myocardial infarction, | 5 years follow up | Occurence of myocardial infarction, |
| Vascular death, | 5 years follow up | Death atttributed to a vascular cause |
| Cranial narve palsy | 5 years follow up | Occurence of paralysis of any last cranial nerve (ranked by frequency: XII, X, VII, IX, XI, or sympathic cervical nerve with Claude Bernard Horner syndrome) |
| Functional outcome | at 5 years | Modified Rankin Scale (mRS) score, |
| Health-related quality of live | At 5 years | Health-related quality of live assesed using EuroQol 5 Dimensions (EQ-5D-5L) questionnaire. |
| Stroke or death during periprocedural phase or ipsilateral symptomatic cerebral or retinal infarction at 5-years | periprocedural period (30 days) and 5 years follow-up | Composite of any stroke or death during the periprocedural period (within 30 days after the procedure), or ipsilateral symptomatic cerebral or retinal infarction during 5 years of follow-up |
| Arterial blood pressure as Best Medical Management (BMM) compliance | 5 years | compliance with best medical management assessed from • Arterial blood pressure (mmHg) |
| Low Density Lipoprotein (LDL) cholesterol level as Best Medical Management (BMM) compliance | 5 years | compliance with best medical management assessed from • Low Density Lipoprotein (LDL) cholesterol level (g/L or mmol/L) |
| Glycated haemoglobin level as compliance with Best Medical Management (BMM) compliance | 5 years | Compliance with best medical management assessed from routine clinical bioliological data Glycated haemoglobin level (%) |
| Tobacco cessation as Best Medical Management (BMM) compliance | 5 years | Compliance with best medical management assessed from routine assessment : • Tobacco cessation or consumption (YES/NO) |
| Alcohol consumption as as Best Medical Management (BMM) compliance | 5 years | Compliance with best medical management assessed from routine assessment : • Alcohol consumption (drinks/week) |
| Daily physical activity assessment as best Medical Management (BMM) compliance | 5 years | compliance with best medical management assessed from routine clinical assessment : • Daily physical activity assessment (hours/week) |
| Any stroke or death during the periprocedural period, or ipsilateral symptomatic cerebral infarction during 2-Year follow-up | 30 days after procedure and up to 2 years | * 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 (2 years) |
| Ipsilateral symptomatic cerebral or retinal infarction at 2-years | 2 years follow-up | occurance of Ipsilateral symptomatic cerebral infarction after randomization |
| Any symptomatic ischemic stroke at 2-years | 2 years follow-up | Occurance of any symptomatic ischemic stroke |
| Any symptomatic stroke at 2-years | 2 years follow-up: | Occurrence of symptomatic stroke (ischemic or hemorrhagic), |
| Myocardial infarction at 2-years | 2 years follow up | Occurence of myocardial infarction, |
| Vascular death at 2-years | 2 years follow up | Death atttributed to a vascular cause |
| Cranial narve palsy at 2-years | 2 years follow up | Occurence of paralysis of any last cranial nerve (ranked by frequency: XII, X, VII, IX, XI, or sympathic cervical nerve with Claude Bernard Horner syndrome) |
| Functional outcome at 2-years | at 2 years | Modified Rankin Scale (mRS) score, |
| Health-related quality of live at 2-years | At 2 years | Health-related quality of live assesed using EuroQol 5 Dimensions (EQ-5D-5L) questionnaire. |
| Stroke or death during periprocedural phase or ipsilateral symptomatic cerebral or retinal infarction at 2-years | periprocedural period (30 days) and 2 years follow-up | Composite of any stroke or death during the periprocedural period (within 30 days after the procedure), or ipsilateral symptomatic cerebral or retinal infarction during 5 years of follow-up |
| Arterial blood pressure as Best Medical Management (BMM) compliance at 2-years | 2 years | compliance with best medical management assessed from • Arterial blood pressure (mmHg) |
| Low Density Lipoprotein (LDL) cholesterol level as Best Medical Management (BMM) compliance at 2-years | 2 years | compliance with best medical management assessed from • Low Density Lipoprotein (LDL) cholesterol level (g/L or mmol/L) |
| Glycated haemoglobin level as compliance with Best Medical Management (BMM) compliance at 2-years | 2 years | Compliance with best medical management assessed from routine clinical bioliological data Glycated haemoglobin level (%) |
| Tobacco cessation as Best Medical Management (BMM) compliance at 2-years | 2 years | Compliance with best medical management assessed from routine assessment : • Tobacco cessation or consumption (YES/NO) |
| Alcohol consumption as as Best Medical Management (BMM) compliance at 2-years | 2 years | Compliance with best medical management assessed from routine assessment : • Alcohol consumption (drinks/week) |
| Daily physical activity assessment as best Medical Management (BMM) compliance at 2-years | 2 years | compliance with best medical management assessed from routine clinical assessment : • Daily physical activity assessment (hours/week) |
Contacts
CONTACTSébastien RICHARD, Professor
Outcome results
None listed