A Comparative Study of Carotid Artery Stenosis Stenting With Balloon Guide Catheter Combined With Distal Filter Versus Distal Filter Alone-A Multicenter, Prospective, Open-label, Endpoint-blinded, Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 296
- 试验地点
- 1
- 主要终点
- Number of New Ischemic Lesions on Diffusion-Weighted Imaging (DWI)
研究概览
简要总结
This multicenter, randomized, controlled trial evaluates a combined embolic protection strategy during carotid artery stenting (CAS). Carotid artery stenosis is a major cause of stroke. While stenting is an effective treatment, the procedure itself carries a risk of dislodging plaque debris, which can travel to the brain and cause new strokes or silent brain infarctions.
Currently, a distal filter (protection device) is standardly used to catch debris. However, it may not capture all particles. This study investigates whether adding a Balloon Guide Catheter (BGC)-which temporarily stops blood flow and allows for aspiration-to the standard filter protection is more effective than using the filter alone.
Patients with symptomatic (≥50% stenosis) or asymptomatic (≥70% stenosis) carotid artery stenosis who are scheduled for stenting will be randomly assigned to one of two groups:
- Combined Protection Group: Receiving CAS using a Balloon Guide Catheter combined with a distal filter.
- Standard Protection Group: Receiving CAS using a distal filter alone. The primary goal is to determine if the combined approach reduces the number of new ischemic lesions detected on brain MRI within 72 hours post-procedure. The study will also assess clinical stroke events over a 90-day follow-up period.
详细描述
Pre-specified subgroup analyses will be conducted based on baseline symptom status (symptomatic vs. asymptomatic carotid artery stenosis) and stent design (open-cell vs. closed-cell).
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
- 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
- •Age 18 years or older;
- •Symptomatic extracranial carotid artery stenosis (occurrence of transient ischemic attack or non-disabling stroke in the ipsilateral carotid territory within the previous 6 months, with stenosis of 50% or greater) or asymptomatic extracranial carotid artery stenosis (stenosis of 70% or greater) meeting the indications for interventional treatment (stenosis degree measured by the NASCET method);
- •Pre-treatment modified Rankin Scale (mRS) score of 0 to 1;
- •Planned for stent treatment by the clinical care team;
- •Informed consent obtained from the patient or their legally authorized representative.
排除标准
- •Occlusion or severe stenosis (70% or greater) of the intracranial segment of the ipsilateral internal carotid artery system;
- •Occlusion or severe stenosis (70% or greater) of the contralateral common carotid artery or internal carotid artery;
- •History of stenting in the head and neck vessels within 3 months;
- •Coexisting other cerebrovascular diseases, such as intracranial aneurysms greater than 5 mm or cerebrovascular malformations;
- •Onset of stroke within 7 days;
- •Large old infarctions from previous stroke that may confound the evaluation of endpoints;
- •Contraindications to magnetic resonance imaging (MRI);
- •Definite risk of cardiogenic embolism (e.g., atrial fibrillation, atrial flutter, intracardiac thrombus) or clear indications for anticoagulation therapy;
- •Absolute or relative contraindications to antiplatelet therapy;
- •Pregnant or lactating women;
- •Allergy or hypersensitivity to contrast media or stent materials (e.g., Nitinol);
- •Life expectancy less than 1 year;
- •Pre-existing neurological or psychiatric disorders (e.g., severe dementia) that would confound neurological assessments;
- •Severe renal insufficiency (eGFR less than 30 mL/min).
研究组 & 干预措施
Combined Protection Group (BGC + Filter)
Patients in this group will undergo carotid artery stenting (CAS) using a Balloon Guide Catheter (BGC) for proximal protection combined with a distal filter protection device.
干预措施: Balloon Guide Catheter (Device)
Combined Protection Group (BGC + Filter)
Patients in this group will undergo carotid artery stenting (CAS) using a Balloon Guide Catheter (BGC) for proximal protection combined with a distal filter protection device.
干预措施: Distal Filter Protection Device (Device)
Standard Protection Group (Filter Alone)
Patients in this group will undergo carotid artery stenting (CAS) using a standard guiding catheter and a distal filter protection device alone.
干预措施: Distal Filter Protection Device (Device)
结局指标
主要结局
Number of New Ischemic Lesions on Diffusion-Weighted Imaging (DWI)
时间窗: Post-procedure 72 hours (plus or minus 12 hours)
Assessed by brain MRI (DWI sequences) performed within 72 hours post-procedure. The outcome is defined as the total number of new high-signal intensity lesions observed on the post-procedural DWI compared to pre-procedural baseline (if available) or recognized as new procedural emboli.
次要结局
- Incidence of Any Intracranial Hemorrhage(Post-procedure 48 hours (± 12 hours))
- Incidence of Adverse Events (AEs)(Through study completion, up to 90 days)
- Incidence of Serious Adverse Events (SAEs)(Through study completion, up to 90 days)
- Procedural Success Rate(Intra-operative)
- Rate of Early Neurological Deterioration (NIHSS Worsening)(Post-procedure 72 hours (± 12 hours))
- All-Cause Mortality at 30 Days(30 days (± 5 days))
- Rate of Excellent Functional Outcome (mRS 0-1) at 30 Days(30 days (± 5 days))
- Rate of Functional Independence (mRS 0-2) at 30 Days(30 days (± 5 days))
- Rate of Excellent Functional Outcome (mRS 0-1) at 90 Days(90 days (± 7 days))
- Rate of Functional Independence (mRS 0-2) at 90 Days(90 days (± 7 days))
- Incidence of Symptomatic Intracranial Hemorrhage(Post-procedure 48 hours (± 12 hours))
- Incidence of Symptomatic Intracranial Hemorrhage(Post-procedure 72 hours (± 12 hours))
- Incidence of Any Intracranial Hemorrhage(Post-procedure 72 hours (± 12 hours))
- Total Volume of New Ischemic Lesions on DWI(Post-procedure 72 hours (± 12 hours))
- Procedural Success Rate(Intra-operative)
- Incidence of New Symptomatic Ischemic Stroke(Post-procedure 72 hours (± 12 hours))
- Rate of Early Neurological Deterioration (NIHSS Worsening)(Post-procedure 72 hours (± 12 hours))
- All-Cause Mortality at 30 Days(30 days (± 5 days))
- Rate of Excellent Functional Outcome (mRS 0-1) at 30 Days(30 days (± 5 days))
- Rate of Functional Independence (mRS 0-2) at 30 Days(30 days (± 5 days))
- Quality of Life Assessment using EuroQol Five Dimensions Questionnaire (EQ-5D-5L) at 30 Days(30 days (± 5 days))
- Rate of Excellent Functional Outcome (mRS 0-1) at 90 Days(90 days (± 7 days))
- Rate of Functional Independence (mRS 0-2) at 90 Days(90 days (± 7 days))
- Quality of Life Assessment using EuroQol Five Dimensions Questionnaire (EQ-5D-5L) at 90 Days(90 days (± 7 days))
- Incidence of Symptomatic Intracranial Hemorrhage(Post-procedure 48 hours (± 12 hours))
- Incidence of Any Intracranial Hemorrhage(Post-procedure 48 hours (± 12 hours))
- Incidence of Adverse Events (AEs)(Through study completion, up to 90 days)
- Incidence of Serious Adverse Events (SAEs)(Through study completion, up to 90 days)
研究者
Xiaochuan Huo
Director
Beijing Anzhen Hospital