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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,440
- 主要终点
- Any stroke or death during the periprocedural period, or ipsilateral symptomatic cerebral infarction during long-term follow-up
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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% plaque
- •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
排除标准
- •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
研究组 & 干预措施
Control Group
patients treated with BMM alone
干预措施: Control group (Other)
Experimental group endarterectomy
patients treated with intervention endarterectomy plus BMM
干预措施: endarterectomy (Procedure)
Experimental group stenting
patients treated with intervention stenting plus BMM
干预措施: stenting (Procedure)
结局指标
主要结局
Any stroke or death during the periprocedural period, or ipsilateral symptomatic cerebral infarction during long-term follow-up
时间窗: 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)
次要结局
- 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)
- Cranial narve palsy(5 years follow up)
- Functional outcome(at 5 years)
- Health-related quality of live(At 5 years)
- 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)
- Arterial blood pressure as Best Medical Management (BMM) compliance(5 years)
- Low Density Lipoprotein (LDL) cholesterol level as Best Medical Management (BMM) compliance(5 years)
- Glycated haemoglobin level as compliance with Best Medical Management (BMM) compliance(5 years)
- Tobacco cessation as Best Medical Management (BMM) compliance(5 years)
- Alcohol consumption as as Best Medical Management (BMM) compliance(5 years)
- Daily physical activity assessment as best Medical Management (BMM) compliance(5 years)
- 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)
- Ipsilateral symptomatic cerebral or retinal infarction at 2-years(2 years follow-up)
- Any symptomatic ischemic stroke at 2-years(2 years follow-up)
- Any symptomatic stroke at 2-years(2 years follow-up:)
- Myocardial infarction at 2-years(2 years follow up)
- Vascular death at 2-years(2 years follow up)
- Cranial narve palsy at 2-years(2 years follow up)
- Functional outcome at 2-years(at 2 years)
- Health-related quality of live at 2-years(At 2 years)
- 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)
- Arterial blood pressure as Best Medical Management (BMM) compliance at 2-years(2 years)
- Low Density Lipoprotein (LDL) cholesterol level as Best Medical Management (BMM) compliance at 2-years(2 years)
- Glycated haemoglobin level as compliance with Best Medical Management (BMM) compliance at 2-years(2 years)
- Tobacco cessation as Best Medical Management (BMM) compliance at 2-years(2 years)
- Alcohol consumption as as Best Medical Management (BMM) compliance at 2-years(2 years)
- Daily physical activity assessment as best Medical Management (BMM) compliance at 2-years(2 years)
研究者
Dr Sebastien RICHARD
Professor
Central Hospital, Nancy, France