NCT07377422尚未招募不适用
Safety and Efficacy of a Novel Composite-Tip Guiding Catheter in Transcarotid Artery Stenting Via Transradial Access: A Prospective, Multicenter, Randomized Controlled Trial
Beijing Anzhen Hospital1 个研究点 分布在 1 个国家目标入组 204 人开始时间: 2026年1月19日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- Transradial Access Success Rate Within 10 Minutes
研究概览
简要总结
This study aims to evaluate the safety and efficacy of the novel composite-tip guiding catheter for transradial access in Carotid Artery Stenting procedures
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;
- •Patients who are candidates for endovascular intervention with CTA-confirmed stenosis in the common carotid artery or C1 segment of internal carotid artery(Symptomatic: ≥50% stenosis; Asymptomatic: 70%-99% stenosis）（NASCET criteria) ;
- •Symptomatic carotid artery stenosis: Non-disabling ischemic stroke or transient ischemic symptoms (TIA, including hemispheric events or transient monocular blindness) within 180 days prior to randomization;
- •Asymptomatic Carotid Stenosis: No history or examination findings suggestive of ipsilateral carotid ischemic symptoms(Non-carotid symptoms, contralateral carotid symptoms, symptom onset >180 days prior to randomization, or vertebrobasilar symptoms are classified as asymptomatic).
- •Palpable radial pulse and negative Allen's test (confirming adequate ulnar collateral circulation);
- •Feasible transradial access with achievable device delivery to the target lesion per operator assessment;
- •Patients or legally authorized representatives comprehend the study purpose, voluntarily participate with signed informed consent, and commit to complete follow-up.
排除标准
- •Patients with severe vascular tortuosity/dissection, extensive or diffuse atherosclerotic lesions involving the aortic arch or proximal common carotid artery, or post-surgical anatomy impeding catheter delivery;
- •Severe stenosis, aneurysms ≥5mm in maximum diameter, arteriovenous malformations (AVM), or other significant cerebrovascular diseases in ipsilateral intracranial/extracranial arteries beyond the target vessel;
- •Patients requiring simultaneous bilateral carotid interventions;
- •Contraindicated in patients with severe allergies to interventional devices or agents related to carotid stenting (e.g., lidocaine, contrast agents, aspirin, clopidogrel);
- •Preprocedural mRS ≥3;
- •Progressive stroke within 2 weeks, hemorrhagic transformation of ischemic stroke within 3 months, or spontaneous intracranial hemorrhage within 12 months;
- •Severe hematologic disorders (active bleeding, severe anemia, coagulopathy, or transfusion dependency), severe heart failure, severe hepatic/renal impairment, or acute coronary syndrome;
- •Malignancy or life expectancy <1 year.
研究组 & 干预措施
Composite-Tip Transradial Neurovascular Distal Access Catheter
Experimental
干预措施: Composite-Tip Transradial Neurovascular Distal Access Catheter (Device)
Straight or Single-Curve Tip Guiding Catheter
Active Comparator
干预措施: Straight or Single-Curve Tip Guiding Catheter (Device)
结局指标
主要结局
Transradial Access Success Rate Within 10 Minutes
时间窗: Intra-procedure
次要结局
- Success Rate of Transradial Access Carotid Artery Stenting(Immediately post-procedure)
- Primary Success Rate of Transradial Access Establishment(Intra-procedure)
- Transradial-to-Transfemoral Conversion Rate(Intra-procedure)
- X-ray Radiation Exposure(Intra-procedure)
- Clinician User Experience Assessment(Immediately post-procedure)
- National Institutes of Health Stroke Scale (NIHSS) Score(Pre-discharge)
- Post-Procedure Modified Rankin Scale (mRS) Score(Pre-discharge)
- Incidence Rate of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)(Pre-discharge，30 days post-procedure)
- Incidence Rate of All-Cause Death(Pre-discharge，30 days post-procedure)
- Incidence Rate of Any Stroke(Pre-discharge，30 days post-procedure)
- Incidence Rate of Target Vessel-Related Ischemic Stroke(Pre-discharge，30 days post-procedure)
- Incidence Rate of Any Myocardial Infarction(Pre-discharge，30 days post-procedure)
- Incidence Rate of Any Revascularization(Pre-discharge，30 days post-procedure)
- Incidence Rate of Radial Artery Occlusion(Pre-discharge)
研究者
Guo Xu
Associate Chief Physician
Beijing Anzhen Hospital
研究点 (1)
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