Safety and Efficacy of Carotid Artery Stenting Combined With Intermittent Hypoxia Intervention in Patients With Severe Internal Carotid Artery Stenosis: A Proof-of-Concept Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Incidence of ≥1 new cerebral lesion detected on brain diffusion-weighted imaging (DWI) within 48 hours after carotid artery stenting (CAS).
研究概览
简要总结
This study aims to explore the efficacy of Intermittent Hypoxia Treatment (IHT) in preventing peri-operative embolism-related microinfarcts among patients with severe internal carotid artery stenosis (ICAS) undergoing carotid artery stenting (CAS).
详细描述
Study Objective：To explore the safety and efficacy of Intermittent Hypoxia Treatment (IHT) for the prevention of peri-operative embolism-induced microinfarcts in patients with severe internal carotid artery stenosis (ICAS) undergoing carotid artery stenting (CAS).Study Content：A proof-of-concept phase 2 randomized controlled trial will be conducted to analyze the safety and potential protective effects of IHT in patients with ICAS receiving stent implantation. Intermittent hypoxia treatment will be administered pre-operatively and post-operatively, and differences including the incidence of postoperative microinfarcts will be compared between the two groups.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-70 years, BMI 18.5-24 kg/m², of any gender; treated in the Department of Neurology or Neurosurgery of our hospital and scheduled for carotid artery stenting.
- •Severe stenosis to occlusion (70-99%) of unilateral internal carotid artery (ICA) demonstrated by carotid ultrasound, Computed Tomography Angiography or Magnetic Resonance Angiography (per NASCET criteria).
- •No history of relevant drug allergy; tolerable to clopidogrel, aspirin and statins.
- •Good compliance, capable of cooperating with and completing brain MRI examinations.
- •For female subjects of child-bearing potential, a negative pregnancy test shall be confirmed prior to enrollment.
- •Stable vital signs with no significant abnormalities in liver and renal function tests.
- •Fully informed of the study content before trial participation and voluntarily providing written informed consent.
排除标准
- •Progressive stroke.
- •Prior ipsilateral stroke with residual neurological deficits.
- •Severe dementia at enrollment.
- •Uncorrected severe cardiovascular diseases (e.g., myocardial infarction within 30 days prior to enrollment, severe heart failure).
- •Severe arrhythmia or chronic atrial fibrillation.
- •Pulmonary disease (Chronic Obstructive Pulmonary Disease，COPD), respiratory insufficiency, or requirement for oxygen supplementation.
- •Uncontrolled hypertension (systolic blood pressure ≥200 mmHg despite pharmacotherapy at enrollment).
- •Concurrent participation in another device or drug clinical trial.
- •Any condition that prevents angiographic assessment or renders percutaneous arterial puncture unsafe.
- •High-risk patients as defined by the Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST).
- •Near-occlusion (90-99%) or occlusion of unilateral internal carotid artery (ICA) shown on carotid ultrasound, CTA or MRA (per NASCET criteria).
- •Other contraindications to intermittent hypoxia treatment.
研究组 & 干预措施
Carotid Artery Stenting only
Patients receive standard-of-care carotid artery stenting without additional interventions
干预措施: Standard Medical Therapy (Other)
Carotid Artery Stenting Combined with Intermittent Hypoxia Intervention
Patients receive intermittent hypoxia therapy plus standard carotid artery stenting. Brain MRI, blood sampling and other examinations are performed upon completion of treatment and within 48 hours post-surgery.
干预措施: intermittent hypoxia intervention (Procedure)
Carotid Artery Stenting Combined with Intermittent Hypoxia Intervention
Patients receive intermittent hypoxia therapy plus standard carotid artery stenting. Brain MRI, blood sampling and other examinations are performed upon completion of treatment and within 48 hours post-surgery.
干预措施: Carotid Artery Stenting (CAS) (Procedure)
Carotid Artery Stenting Combined with Intermittent Hypoxia Intervention
Patients receive intermittent hypoxia therapy plus standard carotid artery stenting. Brain MRI, blood sampling and other examinations are performed upon completion of treatment and within 48 hours post-surgery.
干预措施: Standard Medical Therapy (Other)
Carotid Artery Stenting only
Patients receive standard-of-care carotid artery stenting without additional interventions
干预措施: Carotid Artery Stenting (CAS) (Procedure)
结局指标
主要结局
Incidence of ≥1 new cerebral lesion detected on brain diffusion-weighted imaging (DWI) within 48 hours after carotid artery stenting (CAS).
时间窗: Within 48 hours after carotid artery stenting
次要结局
- Incidence of acute cerebrovascular event within 1 month after CAS(Within 1 month after CAS)
- Number and volume of new cerebral lesions within 48 hours after CAS.(Within 48 hours after CAS)
- Change in Heart Rate (HR) Within 72 Hours After CAS(Within 72 hours after surgery)
- Change in Peak Systolic Velocity (PSV) in Intracranial and Extracranial Arteries Measured by Ultrasound From Baseline to Within 72 Hours After CAS(From baseline to within 72 hours after CAS)
- Incidence of Restenosis Assessed by Computed Tomographic Angiography (CTA) Within 72 Hours After CAS(Within 72 hours after CAS)
- Number of New Cerebral Lesions on DWI Within 48 Hours After CAS(Within 48 hours after CAS)
- Incidence of acute myocardial infarction within 1 month after CAS.(within 1 month after CAS)
- Incidence of All-Cause Death Within 1 Month After CAS(within 1 month after CAS)
- Volume of New Cerebral Lesions on DWI Within 48 Hours After CAS(Within 48 hours after CAS.)
- Change in Heart Rate Variability (HRV) Within 72 Hours After CAS(Within 72 hours after CAS.)
- Change in Blood Pressure (BP) Within 72 Hours After CAS(Within 72 hours after CAS.)
- Change in Intracranial Pressure (ICP) Within 72 Hours After CAS(Within 72 hours after CAS.)
- Change in Cerebral Perfusion Pressure (CPP) Within 72 Hours After CAS(Within 72 hours after CAS.)
研究者
Ji Xunming,MD,PhD
Professor of Neurology, Xuanwu Hospital, Capital Medical University
Capital Medical University