Endarterectomy Versus Stenting in Patients With Symptomatic Severe Carotid Stenosis - 2
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- DWI Lesion Detection Rate
研究概览
简要总结
Carotid stenosis caused by atherosclerosis is a significant risk factor for ischemic stroke, accounting for up to 15% of all strokes and transient ischemic attacks. Randomized clinical trials (RCTs) have demonstrated the benefits of carotid endarterectomy (CEA) in reducing stroke risk in patients with severe symptomatic carotid stenosis. Carotid artery stenting (CAS) has been developed as an alternative to CEA, offering several potential advantages, such as avoiding local surgical complications. However, unlike CEA, CAS has not been compared to medical therapy in RCTs for symptomatic carotid stenosis.
详细描述
CEA vs CAS Comparison:
Early RCTs conducted in the 2000s showed that CAS was associated with a higher risk of procedural stroke or death compared to CEA (8.9% vs 5.8%; RR 1.53, 95% CI 1.20-1.96, p=0.0006). However, CAS was found to be as effective as CEA in preventing recurrent ipsilateral strokes up to 10 years after treatment. Interestingly, an ancillary study of the ICSS trial showed that significantly more patients in the CAS group (50%) than in the CEA group (17%) had new ischemic lesions on diffusion-weighted MRI (DWI), suggesting that DWI might serve as a surrogate outcome measure for future carotid intervention trials.
Data Analysis and Recent Advances:
Individual pooled data analysis of RCTs indicated that CAS could be as safe and effective as CEA in patients under 70 years old. Recent advances in CAS technology, stenting techniques, antiplatelet therapy, and pre-treatment imaging have improved the periprocedural safety of CAS. Due to its ability to treat patients soon after a stroke, CAS has become increasingly used in routine clinical practice.
Study Objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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
- •Patient age 18 years or over
- •Hemispheric or retinal transient ischemic attack or a non-disabling stroke (or retinal infarct) within 15 days before enrolment
- •Stenosis of 50% to 99% in the symptomatic carotid artery (NASCET method) for whom revascularisation is decided according to guidelines
排除标准
- •Patients unwilling or unable to participate in follow-up for whatever reason
- •Preexisting disability (Modified Rankin Score ≥ 3)
- •Nonatherosclerotic carotid disease
- •Severe tandem lesions
- •Previous revascularization of the symptomatic carotid stenosis
- •History of bleeding disorder
- •Unstable angina
- •Contraindication to dual antiplatelet therapy
- •Contraindication to MRI
- •Life expectancy of less than 2 years
- •Percutaneaous or surgical intervention within 30 days before or after the study procedure
- •Stenotic lesion on arterial workup appeared as not a factor in the selection
研究组 & 干预措施
surgical arm
carotid endarterectomy
干预措施: carotid endarterectomy (Procedure)
Stenting arm
Carotid artery stenting
干预措施: Carotid artery stenting (Procedure)
结局指标
主要结局
DWI Lesion Detection Rate
时间窗: From 3 days before procedure to 7 days after procedure
Imaging endpoint : Proportion of patients having at least one new lesion on post-treatment Diffusion-Weigthed Imaging (DWI) MRI compared to pre-treatment DWI MRI and confirmed by a core lab. The pre-treatment DWI MRI will be performed within 3 days before procedure. The post-treatment DWI MRI will be performed within 7 days after procedure.
次要结局
- Procedure Delay(From the date of patient randomization until the date of carotid artery stenting (CAS) or endarterectomy (CEA) procedure, assessed up to 15 days)
- Hospitalization Duration(From the date of the carotid artery stenting (CAS) or endarterectomy (CEA) procedure until the date of hospital discharge, assessed up to 30 days)
- Profile of lesions(From 3 days before procedure to 7 days after procedure)
- Vessel Occlusion Profile(From 3 days before procedure to 7 days after procedure)
- Hemorrhage(From 3 days before procedure to 7 days after procedure.)
- Stroke/Mortality(From randomization to 30 days after procedure)
- Stroke Incidence Rate(From randomization to 30 days after procedure)
- Severe Stroke Incidence(From randomization to 30 days after procedure)
- Mortality(From randomization to 30 days after procedure)
- TIA Incidence(From randomization to 30 days after procedure)
- MI Occurrence(From randomization to 30 days after procedure)
- Local complication(From randomization to 30 days after procedure)
- Cranial Nerve Injury Events(From randomization to 30 days after procedure)
- Ischemic Events(From 3 days before procedure to 7 days after procedure.)
- Hemorrhage(From 3 days before procedure to 7 days after procedure)