A Prospective, Multi-center, Single Arm Clinical Study to Evaluate the Safety and Effectiveness of the Flow Diverter Stent System in the Treatment of Cerebral Aneurysms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 143
- 试验地点
- 1
- 主要终点
- Successful aneurysm occlusion at 1 year post procedure
研究概览
简要总结
The primary objective of this trial is to evaluate the safety and efficacy of the cerebral flow diverter in the endovascular treatment of wide-necked cerebral aneurysms
详细描述
The investigation is a prospective, multi-center, single arm clinical study. The trial is anticipated to last from March 2023 to January 2025 with 143 subjects recruited in around 10 China centers. The population for this study is subjects with wide-necked intracranial aneurysms who are suitable candidates for flow diverter implantation. Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be enrolled after offering informed consent form. The study consists of six visits including preoperative screening, operation date, 7days or at discharge, 30 days, 180 days, and 1 year. The primary endpoint was successful aneurysm occlusion at one year post-procedure.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years to 75 years, male or non-pregnant female.
- •Unruptured wide-necked cerebral aneurysms confirmed by preoperative imaging (Wide-necked is defined as width ≥ 4 mm or a dome-to-neck ratio < 2).
- •Parent vessel with a diameter range of 1.75-6.0 mm.
- •Those who voluntarily participate in the study and sign informed consent form.
排除标准
- •Subject with target aneurysms are blood blister-like aneurysms, pseudoaneurysms, arteriovenous malformation, moyamoya disease-related aneurysm, or multiple aneurysms that cannot be treated with a single stent.
- •Severe arteriosclerosis or tortuosity of intracranial artery, and the device is difficult to reach the target vessel.
- •Subject with target aneurysm previously treated with craniotomy or other endovascular interventional therapy.
- •Known sensitivity to antiplatelet medications, anticoagulant medications, radiographic contrast agents, anesthetic, nickel, platinum-tungsten alloy, platinum-iridium alloy, and poly-N-[Tris(hydroxymethyl)methyl] acrylamide (poly-NTMA).
- •Severe respiratory system, liver and kidney diseases (such as creatinine ≥ 3.0 mg/dL (except dialysis)) or blood coagulation disorders before operation.
- •Platelet count is less than 100×109/L, international normalized ratio (INR) is more than 1.
- •Hospitalized surgical treatment within the previous 30 days or planned within the next 180 days after operation.
- •Severe neurological deficit that renders the patient incapable of living independently (modified Rankin score ≥3).
- •The survival expectation is less than 1 year.
- •All subjects who are participating in other drug/medical device clinical trials and have not completed the programme requirements
- •Inapplicable for this study at the investigators' viewpoints.
研究组 & 干预措施
Cerebral flow diverter
The cerebral flow diverter in the endovascular treatment of wide-necked cerebral aneurysms
干预措施: Cerebral flow diverter (Device)
结局指标
主要结局
Successful aneurysm occlusion at 1 year post procedure
时间窗: 1 year post procedure
The Raymond-Roy occlusion classification (RROC) is an angiographic classification scheme for grading the occlusion of flow diverter treated cerebral aneurysms (class I: complete obliteration, class II: residual neck, class III: residual aneurysm). Higher class represent a worse outcome. The percentage of Successful aneurysm occlusion in which class 1 or 2 is achieved on the Raymond Scale at one year follow-up angiographic assessments will be evaluated.
Complete aneurysm occlusion without significant parent artery stenosis (≤50%) or retreatment at 1 year post procedure
时间窗: 1 year post procedure
Proportion of subjects with complete occlusion of the target aneurysm, ≤50% stenosis of the parent artery at the target cerebral aneurysms at 1 year as assessed by angiography, and in whom an unplanned alternative treatment of the target cerebral aneurysms had not been performed within 1 year.
Major stroke in the territory supplied by the treated artery or neurological death at 1 year post procedure
时间窗: 1 year post procedure
National Institute of Health Stroke Scale (NIHSS) was used to assess patients after stroke in an 11-item scale with potential scores ranging from 0 to 42. Higher values represent a worse outcome. A major stroke is defined as a new neurological event which is ipsilateral and in the vascular distribution territory of the stenting procedure and that results in an increase of ≥ 4 on the NIHSS as compared to baseline.
次要结局
- Immediate procedural success rate(Intra-procedure)
- Ischemic cerebrovascular events caused by thromboembolism at 180 days and 1 year post procedure(180 days and 1 year post procedure)
- Complete aneurysm occlusion rate at 180 days and 1 year post procedure(180 days, 1 year post procedure)
- All-cause mortality at 30 days, 180 days and 1 year post procedure(30 days, 180 days and 1 year post procedure)
- Any stroke at 30 days, 180 days and 1 year post procedure(30 days, 180 days and 1 year post procedure)
- Incidence of operation or device-related adverse events/serious adverse events during hospitalization, 30 days, 180 days and 1 year post procedure(hospitalization, 30 days, 180 days and 1 year post procedure)
- Rate of Device defect(within 1 year of whole trial)
- Target aneurysmal hemorrhage at 180 days and 1 year post procedure(180 days and 1 year post procedure)
- Major stroke in the territory supplied by the treated artery or neurological death at 180 days and 1 year post procedure(180 days and 1 year post procedure)
- Successful aneurysm occlusion at 180 days post procedure(180 days post procedure)
- Complete aneurysm occlusion without significant parent artery stenosis (≤50%) or retreatment at 180 days and 1 year post procedure(180 days and 1 year post procedure)
- Success aneurysm occlusion at 180 days and 1 year post procedure(180 days and 1 year post procedure)
- Complete aneurysm occlusion without significant parent artery stenosis (≤50%) or retreatment at 180 days post procedure(180 days post procedure)
- Major stroke in the territory supplied by the treated artery or neurological death at 180 days post procedure(180 days post procedure)