A Prospective, Multi-center, Randomized Controlled, Clinical Trial to Evaluate the Safety and Efficacy of NxiDIME™ Intracranial Drug-eluting Self-expanding Stent System
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- 12-month incidence rate of in-stent restenosis
研究概览
简要总结
This investigation is a prospective, multicenter, randomized controlled, non-inferiority clinical trial, to evaluate the safety and efficacy of the investigational device against alternative models/specifications of the control device. The study will be conducted across multiple Chinese centers, with planned enrollment of 224 patients with symptomatic intracranial atherosclerotic stenosis. Subjects meeting all inclusion criteria and without any exclusion criteria will enter the investigation after providing written informed consent via ethics committee-approved informed consent forms (ICFs). The randomized controlled study plans to enroll 224 patients, stratified by intracranial lesion location (anterior/posterior circulation), through a centralized randomization system. The experimental group will receive the NxiDIME™ Intracranial Drug-Eluting Stent System (RICOTON Technology Co., Ltd.), while the control group will receive the NOVADES® Intracranial Drug-Eluting Stent System.
All subjects underwent follow-up visits on the day of the procedure, within 7 days postoperatively or prior to discharge, and at 30 days, 6 months, and 12 months postoperatively.
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
盲法说明
Prospective randomized open blinded end-point (PROBE) study
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old and ≤ 80 years old, regardless of gender.
- •Symptomatic intracranial arterial stenosis (TIA/ischemic stroke within 180 days attributed to intracranial arteries including the intracranial internal carotid artery, middle cerebral artery, intracranial vertebral artery, or basilar artery, with stenosis severity ≥70% and ≤99% measured by DSA using WASID criteria), currently receiving at least one antiplatelet therapy;
- •Poor collateral circulation or hypoperfusion in the target vessel territory (Poor collateral circulation: American Society of Interventional and Therapeutic Neuroradiology/Society of Interventional Radiology (ASITN/SIR) score < 3; Hypoperfusion:
- •The cerebral blood flow (CBF) in the target artery territory decreases by > 30% during CT or magnetic resonance perfusion imaging (MR perfusion); or
- •There are hemodynamic ischemic lesions on MRI or CT, such as watershed infarction);
- •Target lesion vessel diameter 1.0-5.5 mm with lesion length ≤40 mm (If: 2.25 mm ≤ target vessel diameter ≤4.0 mm and lesion length ≤15 mm, enroll in randomized controlled study; 1.0 mm ≤ target vessel diameter <2.25 mm or 4.0 mm < target vessel diameter ≤5.5 mm or 15 mm < lesion length ≤40 mm, enroll in single-arm cohort study);
- •mRS score ≤ 2;
- •Patient or legal guardian voluntarily participates and signs the written ICF, with willingness to comply with protocol-specified examinations and follow-up.
排除标准
- •History of prior stent implantation or surgical treatment at the target lesion;
- •Intracranial hemorrhage within 30 days preoperatively or presence of untreated chronic subdural hematoma ≥5 mm;
- •Major surgical procedure within 30 days prior to the procedure;
- •Acute ischemic stroke within 14 days prior to the procedure;
- •Symptomatic carotid stenosis ≥50% outside the target lesion, or coexisting intracranial/extracranial vascular stenosis ≥70% requiring intervention;
- •Severe calcification, significant stenosis, or tortuosity of the target vessel precluding device deployment as assessed by investigators;
- •Intracranial tumor, arteriovenous malformation, or tandem aneurysms proximal/distal to the target lesion;
- •Non-atherosclerotic stenosis etiology (e.g., arterial dissection, moyamoya disease, vasculitis);
- •Cardiac thromboembolic sources (e.g., atrial fibrillation, left ventricular thrombus, myocardial infarction within 6 weeks);
- •Uncontrolled hypertension (persistent systolic blood pressure (SBP) ≥180 mmHg or diastolic blood pressure (DBP) ≥110 mmHg);
- •Contraindications to antiplatelet/anticoagulant therapy, coagulopathy or bleeding diathesis precluding intervention per investigator judgment;
- •Severe comorbidities: cardiac failure (New York Heart Association (NYHA) Class III-IV), respiratory/renal failure (serum creatinine >3.0 mg/dL (264 μmol/L)), Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) more than 3 times the upper limit of the normal value), active malignancy;
- •Hypersensitivity to rapamycin, polylactic-co-glycolic acid, nitinol, platinum-tungsten, anesthetics, or contrast agents;
- •Life expectancy <1 year;
- •Pregnancy, lactation, or planned pregnancy within 1 year;
- •Concurrent participation in other clinical trials without completing primary endpoint follow-up;
- •Cognitive impairment or psychiatric disorders compromising protocol compliance; other exclusionary conditions per investigator discretion.
结局指标
主要结局
12-month incidence rate of in-stent restenosis
时间窗: 12-month
In-stent restenosis is defined as luminal stenosis \>50% within the stent or adjacent 5-mm segments, accompanied by late lumen loss \>20% relative to immediate post-procedural measurements by follow-up DSA.
次要结局
未报告次要终点
研究者
Feng Gao
Professor
Beijing Tiantan Hospital