Evaluating the Safety and Efficacy of the Carotid Artery Stenting System for Stenosis With High-risk Features for CEA: a Prospective, Multicenter, Single-group Target-value Study in China
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 212
- 试验地点
- 16
- 主要终点
- Stroke, myocardial infarction, and death within 30 days after the procedure, or stroke in the territory of the ipsilateral artery between day 31 and day 365 after the procedure
研究概览
简要总结
The purpose of this prospective, multicenter, single-group target-value study is to evaluate the safety and efficacy of the carotid artery stent system in patients with high-risk features for carotid endarterectomy. This trial is utilizing the carotid artery stent system provided by Shanghai HeartCare Medical Technology Co., Ltd. and will be conducted at approximately 10 interventional neurology centers in China.
详细描述
This trial is a prospective, multicenter, single-group target-value study to evaluate the safety and efficacy of the carotid artery stent system in patients with high-risk features for carotid endarterectomy. The primary outcome is a composite outcome that includes stroke or death within 30 days after enrollment or after a revascularization procedure for the qualifying lesion during the follow-up period or ischemic stroke in the territory of the qualifying artery between day 31 and the end of the follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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, male or female;
- •Pre-procedural carotid duplex ultrasound and/or computed tomography angiography confirmed stenosis of the common carotid artery, internal carotid artery, or carotid bifurcation, and are considered suitable for endovascular treatment;
- •Intra-procedural digital subtraction angiography, using NASCET criteria, confirmed stenosis of ≥ 50% (symptomatic) or ≥ 80% (asymptomatic), and symptomatic is defined as the occurrence of one or more clinical events within 6 months prior to the procedure, including transient ischemic attack, amaurosis fugax, or minor/non-disabling stroke attributable to the ipsilateral intracranial circulation;
- •The vessel diameter of the target lesion is between 3.0 mm and 9.0 mm;
- •Voluntary participation in this trial and provision of written informed consent.
- •Inclusion criteria for high-risk features for carotid endarterectomy:
- •Comorbidity factors:
- •Age ≥ 75 years at the time of enrollment;
- •Patients with congestive heart failure (New York Heart Association Class III/IV);
- •Patients with unstable angina pectoris;
- •Patients with severe chronic obstructive pulmonary disease, defined as an FEV1 ≤ 50% of predicted, requirement for chronic oxygen therapy, or a resting PO₂ ≤ 60 mmHg;
- •Patients with left ventricular ejection fraction ≤ 30%;
- •Patients with recent myocardial infarction (within 2 to 6 weeks);
- •Patients with coronary artery disease with ≥ 70% stenosis in two or more major vessels;
- •Planned coronary artery bypass grafting or valve replacement surgery within 31 to 60 days following the procedure.
- •Anatomical factors:
- •Lesions located at or above the level of the second cervical vertebra (C2) or lesions that are surgically inaccessible below the clavicle;
- •History of radical head and neck surgery or radiotherapy;
- •Patients with limited cervical spine mobility;
- •Patients with tracheostomy;
- •History of vocal cord paralysis or laryngectomy;
- •Patients with contralateral recurrent laryngeal nerve palsy;
- •Patients with restenosis following previous carotid endarterectomy;
- •Patients with severe stenosis or occlusion of the contralateral carotid artery;
- •Severe tandem lesions that can be covered by a single stent.
排除标准
- •Target lesions caused by carotid arteritis;
- •Target lesions located at the origin of the common carotid artery;
- •Target lesions with extensive calcification or excessive tortuosity that preclude stent delivery;
- •Target lesions attributable to asymptomatic complete occlusion or the presence of a "string sign";
- •Target lesions adjacent to significant acute or subacute thrombus, or arteriovenous malformation;
- •History of major surgery (including intra-abdominal, intrathoracic, cardiac, or vascular procedures) within 30 days before the procedure, or any such surgery scheduled within 30 days after the procedure;
- •History of intracranial hemorrhage or progressive stroke within 3 months before the procedure;
- •History of an extensive hemispheric stroke within 2 weeks before the procedure;
- •History of bradycardia (heart rate < 40 bpm) before the procedure;
- •History of paroxysmal atrial fibrillation within the past 6 months, or paroxysmal atrial fibrillation requiring long-term anticoagulation therapy;
- •Patients with known or potential sources of thromboembolism (including previously known symptomatic patent foramen ovale, mechanical heart valves, or deep vein thrombosis treated within 6 months);
- •Patients with a known intracranial aneurysm requiring surgical intervention that cannot be treated before the procedure;
- •Patients with known coagulation disorders (APTT > 3 times the upper limit of normal) or abnormal bleeding disorders;
- •Patients with known contraindications to heparin or antiplatelet agents;
- •Patients with a platelet count < 100×10^9/L;
- •Patients with known allergies to any components of the investigational product, contrast agents;
- •Patients with known severe hepatic or renal insufficiency (ALT or AST > 5 times the upper limit of normal, or serum creatinine > 3 times the upper limit of normal);
- •Patients with known uncontrolled severe hypertension (persistent systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg);
- •Patients with a pre-procedure mRS score > 3;
- •Patients with extensively metastatic malignancy;
- •Patients concurrently enrolled in another drug or medical device clinical trial;
- •Female patients who are currently pregnant or breastfeeding, or who plan to conceive within 1 year;
- •Lesions inaccessible by endovascular approach (including severe tortuosity of aortic arch branches with no suitable access artery, or special aortic arch anatomy);
- •According to the judgment of the investigator, patients with an expected survival of less than 12 months;
- •According to the judgment of the investigator, other situations that are not suitable for enrollment.
研究组 & 干预措施
Carotid artery stent system
Device: The carotid artery stent system, manufactured by Shanghai HeartCare Medical Technology Co., Ltd., is a self-expanding stent constructed from nitinol.
干预措施: Carotid artery stent system (Device)
结局指标
主要结局
Stroke, myocardial infarction, and death within 30 days after the procedure, or stroke in the territory of the ipsilateral artery between day 31 and day 365 after the procedure
时间窗: 30 days after the procedure and 365 days after the procedure
Stroke is defined as an event that causes focal neurological dysfunction or signs and lasts for at least 24 hours, including ischemic stroke and hemorrhagic stroke. Myocardial infarction is defined as an increase in creatine kinase isoenzyme (CK-MB) or troponin in the postoperative period that is at least twice the upper limit of the normal range, accompanied by ischemic symptoms such as chest pain, or the presence of ischemic electrocardiogram evidence. Ischemic stroke in the territory of the ipsilateral artery is defined as an ischemic stroke in the cerebral hemisphere that is supplied with blood flow by the target artery.
次要结局
- In-stent restenosis rate within 12 months after the procedure(365 days after the procedure)
- Implantation success rate(During the procedure)
- Procedure success rate(Before the discharge or 7 days after the procedure)
- In-stent restenosis rate within 6 months after the procedure(6 months after the procedure)
- Symptomatic in-stent restenosis rate(6 months, and 12 months after the procedure)
- Target lesion revascularization rate(30 days, 6 months, and 12 months after the procedure)
- Ischemic stroke in the territory of the ipsilateral artery between day 31 and day 365 after the procedure(12 months after the procedure)