NCT05217459已完成不适用
A Prospective, Multicenter, Objective Performance Criteria Study to Evaluate the Efficacy and Safety of an Intracranial Self-expanding Drug Eluting Stent System for Symptomatic Intracranial Atherosclerotic Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 15
- 主要终点
- The incidence of In-stent restenosis within 6 months after operation
研究概览
简要总结
The primary objective of this trial is to evaluate the safety and efficacy of SINOMED IS- DES in patients with symptomatic intracranial atherosclerotic stenosis.
详细描述
This study is a prospective, multicenter, objective performance criteria clinical trial to evaluate the safety and efficacy of intracranial self-expanding drug stent system in the treatment of symptomatic intracranial atherosclerotic stenosis. A total of 128 patients are planned to be included. The primary endpoint is the incidence of In-stent restenosis at 6 months after operation (ISR is defined as stenosis greater than 50% within or immediately adjacent (within 5 mm) to the implanted stents and absolute luminal loss greater than 20% at 6 months follow-up imaging.). All patients will have clinical follow-up during intraoperative, 30 days, 6 months, 1 year.
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
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •30 to 75 years of age;
- •Patients with symptomatic intracranial atherosclerotic stenosis who failed antiplatelet therapy or poor collateral circulation compensation or hypoperfusion in the territory of the culprit artery;
- •Digital Subtraction Angiography(DSA) showed 70% to 99% stenosis in target intracranial artery
- •The target lesion was in the internal carotid artery (intracranial segment), middle cerebral artery, vertebral artery (intracranial segment), basilar artery, and it was a single lesion that required surgical treatment;
- •The target lesion reference diameter must be visually estimated to be ≥2.0 mm and <4.5mm in diameter, and lesion length of ≤34 mm;
- •The onset of the latest transient ischemic attack (TIA) was not limited or ischemic stroke occurred within 2 weeks prior to stenting procedure;
- •Willingness to participate in this clinical trial and signing the consent form, and be able to complete the corresponding inspections, follow-ups, etc. according to the requirements of the clinical protocol during the clinical trial.
排除标准
- •The target vessels was complete occlusion;
- •>70% stenosis observed at the intracranial large-vessel distal to the target vessel or >70% stenosis observed at the intracranial/extracranial large-vessel proximal to the target vessel;
- •Preoperative magnetic resonance only showed perforating infarction in the target lesion area;
- •Preoperative CT or MRI showed that there was hemorrhage transformation after infarction in the target vessel area, or a history of primary cerebral hemorrhage, or a history of subarachnoid, subdural and epidural hemorrhage within 30 days before operation, or there was no treatment Chronic subdural hematoma ≥5mm;
- •Hospitalized surgical treatment within 30 days before operation, or planned hospitalized surgical treatment within 6 months after surgery;
- •CT showed Severe calcified lesions;
- •Previously received endovascular treatment or surgical intervention at the target vessel (except for patients with simple balloon dilatation);
- •Non-atherosclerosis lesions;
- •Patients with potential sources of cardiac embolism (such as atrial fibrillation, left ventricular thrombosis, myocardial infarction within 6 weeks);
- •Concomitant intracranial tumor, aneurysm or intracranial arteriovenous malformation;
- •Known hypersensitivity to aspirin, heparin, clopidogrel, rapamycin (sirolimus), lactic acid polymer, poly-n-butyl methacrylate, nickel-titanium alloy, or contraindications to anesthetics and contrast agents;
- •Hemoglobin <100g/L, platelet count <100*109/L, International normalized ratio (INR) >1.5 (irreversible) or uncorrectable hemorrhagic factors;
- •Uncontrollable severe hypertension (systolic blood pressure>180mmHg or diastolic blood pressure>110mmHg)；
- •Known liver or renal insufficiency (ALT> 3x upper limit or AST > 3x upper limit, Serum creatinine>250μmol/L);
- •Life expectancy < 1 year;
- •Pregnant/lactating female patients;
- •Patients with cognitive impairment or mental diseases (except for those with cognitive impairment due to arterial stenosis);
- •Patients who were participated in other clinical trials within 3 months or participating in other clinical trials who had not yet reached the primary clinical endpoint;
- •Inapplicable for intravascular stenting treatment as per investigators judgment.
结局指标
主要结局
The incidence of In-stent restenosis within 6 months after operation
时间窗: 6 months after operation
ISR is defined as stenosis greater than 50% within or immediately adjacent (within 5 mm) to the implanted stents and absolute luminal loss greater than 20% at 6 months follow-up imaging.
次要结局
- Procedure success(Immediately after operative)
- Percent of Participants With National Institutes of Health Stroke Scale (NIHSS) Score = 0 or 1 at 6 months follow-up(6 months after operation)
- Incidence of device defects(During operation)
- Stent success(Immediately after operative)
- Rate of good functional outcomes measured by Modified Rankin Score (mRS)(30days, 6 months, 1 year after operation)
- Rate of all revascularization and target lesion revascularization(30days, 31days to 6 months, 1 year after operation)
- The incidence of recurrent ischemic stroke in the target vascular area within 31 days to 6 months, 1 year after operation.(31days to 6 months, 1 year after operation)
- The incidence of recurrent ischemic stroke outside the target vascular area within 31 days to 6 months, 1 year after operation.(31 days to 6 months, 1 year after operation)
- All cause death(31days to 6 months, 1 year after operation)
- Symptomatic ISR within 6 months(within 6 months)
- Adverse events or severe adverse event(31 days to 6 months, 1 year after operation)
- Any stroke or death within 30 days after operation, and the incidence of recurrent ischemic stroke in the target vascular area within 31 days to 6 months, 1 year after operation.(30days, 31days to 6 months, 1 year after operation)
- Any stroke or death within 30 days after operation(Within 30 days after operation)
- Stroke (including hemorrhage or ischemic stroke) or death within 30 days associated with the target vessel(Within 30 days after operation)
- Any parenchymal hemorrhage, subarachnoid hemorrhage or intraventricular hemorrhage(31 days to 6 months, 1 year after operation)
研究者
研究点 (15)
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