Multicenter, Open-label Randomized Study Comparing Urgent Carotid Endarterectomy (CEA) (Within 72 Hours) Versus Delayed CEA (After 72 Hours) in Patients With Symptomatic Carotid Stenosis (SPREAD-STACI II)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 456
- 试验地点
- 2
- 主要终点
- Number of participants with treatment-related death, any type of stroke, and myocardial infarction events as assessed by CTCAE v4.0
研究概览
简要总结
In patients with internal carotid artery (ICA) stenosis of 50% or greater (measured according to the criteria of the North American Symptomatic Carotid Endarterectomy Trial (NASCET)) who have experienced a transient ischemic attack (TIA) or minor ipsilateral stroke, carotid endarterectomy (CEA) offers maximum benefit if performed within 15 days of the initial ischemic symptom. National and international guidelines recommend surgical treatment (CEA) within this timeframe; however, no studies have specifically evaluated the optimal timing for CEA after a TIA or minor stroke.
It is well established that the risk of a major stroke is highest in the first few days following a transient ischemic attack or minor stroke and then decreases over the subsequent days and weeks.
This raises the hypothesis that performing an urgent carotid endarterectomy (within 3 days) may provide greater benefit compared to a delayed procedure (between 4 and 15 days).
详细描述
Background and Rationale
In patients with internal carotid artery (ICA) stenosis of 50% or greater (measured according to the criteria of the North American Symptomatic Carotid Endarterectomy Trial (NASCET)) who have experienced a transient ischemic attack (TIA) or minor ipsilateral stroke, carotid endarterectomy (CEA) offers maximum benefit if performed within 15 days of the initial ischemic symptom. National and international guidelines recommend surgical treatment (CEA) within this timeframe; however, no studies have specifically evaluated the optimal timing for CEA after TIA or minor stroke.
It is well established that the risk of a major stroke is highest in the first few days following a transient ischemic attack or minor stroke and then decreases over the subsequent days and weeks. This raises the hypothesis that performing an urgent carotid endarterectomy (within 3 days) may provide greater benefit compared to a delayed procedure (between 4 and 15 days).
Study Objectives
Primary Endpoint
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligibility Criteria
- •Inclusion Criteria:
- •Patients presenting with the following characteristics:
- •De novo stenosis of the carotid bifurcation and/or internal carotid artery origin, equal to or greater than 50% (NASCET method), diagnosed by color Doppler ultrasound, MR angiography (MRA), CT angiography (CTA), or catheter angiography.
- •TIA or minor ischemic stroke (NIHSS ≤ 5) ipsilateral to the carotid stenosis, occurring within the previous 24 hours.
- •Preserved consciousness and neurologically stable symptoms. No evidence of ongoing cerebral ischemia, or evidence of cerebral ischemia with a diameter <25 mm.
- •Age between 45 and 90 years. ASA score <
- •Ability to comply with follow-up requirements as specified. Willingness to provide informed consent for participation in the study.
- •A patient with an NIHSS ≤ 5 who is aphasic may be unable to provide consent. In these cases:
- •The attending physician assesses the feasibility of including the patient. Family members are informed but, under Italian law, cannot provide consent. A third-party physician certifies that the patient meets the inclusion criteria.
- •The attending physician signs the appropriate form, and randomization proceeds. If and when the patient regains the ability to provide or refuse consent, the informed consent form will be presented to them. Should they decline, their data will be removed from the study database.
- •Additionally, the study includes patients who underwent thrombolysis and/or mechanical thrombectomy after the onset of the index symptom, followed by a brain CT/MRI without secondary cerebral hemorrhage (PH1, PH2, or PHr).
排除标准
- •Stenosis < 50% (NASCET method) at the bifurcation and/or internal carotid artery origin, diagnosed by ECD, CTA, or MRA.
- •Carotid thrombosis or dissection. NIHSS >
- •Cerebral hemorrhage. Impaired consciousness or neurologically unstable condition. Cancer, any condition with a poor prognosis, major cardiopathy, or any severe neurological disorder.
- •CT or MRI evidence of cerebral ischemia > 25 mm in diameter. CT or MRI evidence of cerebral lesions of uncertain origin. Recurrent TIA or stroke-in-evolution. Age < 45 years or > 90 years. ASA risk score =
- •Lack of informed consent. Inability to undergo CEA within 72 hours of the initial ischemic symptom. Inability to participate in a 90-day follow-up after the initial ischemic symptom.
- •Previous CEA or stenting of the examined carotid artery.
研究组 & 干预措施
Group A : Within 72 hours of the ischemic symptom
The study will evaluate the same surgical procedure, carotid endarterectomy (CEA), which involves the removal of the atherosclerotic plaque causing thromboembolism or hemodynamically significant stenosis. This will be performed in two different timeframes:
GROUP A : Within 72 hours of the ischemic symptom. GROUP B: Between 72 hours and 14 days after the symptom.
The two study groups will not differ in the type of treatment offered but only in the timing of its execution.
No experimental procedures will be conducted. Whether CEA is performed within 72 hours or after this period, the surgical procedure will adhere fully to the current guidelines.
干预措施: CEA (carotid endarterectomy) (Procedure)
Group B: Between 72 hours and 14 days after the ischemic symptom
see above
干预措施: CEA (carotid endarterectomy) (Procedure)
结局指标
主要结局
Number of participants with treatment-related death, any type of stroke, and myocardial infarction events as assessed by CTCAE v4.0
时间窗: From enrollment to 90 days follow-up from CEA
Number of patients experiencing death, any type of stroke, and myocardial infarction within 90 days of the ischemic event in group A and B (numerical values)
次要结局
- Number of participants with treatment-related ipsilateral ischemic stroke events as assessed by CTCAE v4.0(From enrollment to 90 days follow-up from CEA)
- Number of participants with treatment-related cerebral hemorrhagic events as assessed by CTCAE v4.0(From enrollment to 90 days follow-up from CEA)
研究者
EMILIANO CHISCI
Principal Investigator, Head of Endovascular Aortic UNIT, San Giovanni di Dio Hospital, USL Toscana Centro, Florence, ITALY
Italian Society of Vascular and Endovascular Surgery