A Prospective, Multicenter, Randomized Controlled Trial to Evaluate the Safety and Effectiveness of the SINOMED IAS for the Treatment of Intracranial Aneurysms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 203
- 试验地点
- 14
- 主要终点
- Success aneurysm occlusion at 6 month post procedure
研究概览
简要总结
The primary objective of this trial is to evaluate the safety and efficacy of SINOMED IAS in patients with intracranial aneurysms.
详细描述
This study is a prospective, multicenter, 1:1 randomized clinical trial to evaluate the safety and efficacy of stent system in the treatment of intracranial aneurysms. A total of 204 patients are planned to be included. The primary efficacy endpoint is complete aneurysm occlusion without retreatment or significant parent artery stenosis at 12 months post-procedure. The primary safety endpoint is the incidence of major ipsilateral stroke or neurogenic death within 12 months post-procedure. 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
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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 to 80 years.
- •Wide-necked (Wide-necked is defined as width ≥ 4 mm or a dome-to-neck ratio < 2), saccular, intracranial aneurysms arising from a parent vessel with a diameter of ≥ 2.5 mm and ≤ 5mm.
- •Modified Rankin Scale (mRS) ≤
- •Subject understands the nature of the procedure, provides voluntary written informed consent prior to the treatment, and is willing to comply with specified follow-up evaluation.
- •The investigators judged the use of stent-assisted coil embolization to be appropriate for the treatment of intracranial aneurysm.
排除标准
- •Target aneurysm is an aneurysm requiring staged procedure.
- •Target aneurysm that has been previously treated with vascular embolization or surgery.
- •Target aneurysms are fusiform aneurysms, dissecting aneurysms, pseudoaneurysms, blood blister-like aneurysms, infected aneurysms, aneurysms associated with arteriovenous malformations.
- •Hospitalized surgical treatment within 30 days before operation, or planned hospitalized surgical treatment within 6 months after surgery.
- •Acutely ruptured aneurysm within 14 days of enrollment.
- •Hunt and Hess (H&H) scale ≥
- •Subject who had Moyamoya disease, arteriovenous malformations, arteriovenous fistulae, intracranial tumors, or intracranial mass lated to target aneurysms.
- •Severe stenosis or tortuosity of intracranial arteries or anatomical anomalies that make it difficult to reach the site of the lesion with device.
- •Platelet count <50*103/mm3 (50*109/L) or any known coagulation deficiency, or International normalized ratio (INR)>3.
- •Known hypersensitivity/allergies or contraindication to contrast media, stent components, antiplatelets, anticoagulants.
- •Life expectancy < 1 year, and unable to complete the required follow-ups;
- •Female who was pregnant or breastfeeding, women/men planning to havve children in the next year.
- •Currently enrolled in another investigational device or drug study.
研究组 & 干预措施
SINOMED IAS Stent System
The SINOMED IAS Stent System is intended for use with occlusive devices in the treatment of intracranial aneurysms.
干预措施: SINOMED IAS Stent System (Device)
Neuroform Atlas Stent System
The Neuroform Atlas Stent System is intended for use with occlusive devices in the treatment of intracranial aneurysms.
干预措施: Neuroform Atlas Stent System (Device)
结局指标
主要结局
Success aneurysm occlusion at 6 month post procedure
时间窗: 6 months 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 Success aneurysm occlusion in which class 1 or 2 is achieved on the Raymond Scale at the 6 months follow-up angiographic assessments will be evaluated.
The primary efficacy endpoint is complete aneurysm occlusion without retreatment or significant parent artery stenosis at 12 months post-procedure
时间窗: 12 months 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 12 months.
The primary safety endpoint is the incidence of major ipsilateral stroke or neurogenic death within 12 months post-procedure
时间窗: 12 months 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
- Retreatment Rate at 6 months and 1 year post procedure(6 months, 1 year post procedure)
- Modified Rankin Scale (mRS) at 30 days, 6 months and 1 year post procedure(30 days, 6 months, 1 year post procedure)
- Major ipsilateral stroke at 30 days, 6 months and 1 year post procedure(30 days, 6 months, 1 year post procedure)
- All-cause mortality at 30 days, 6 months and 1 year post procedure(30 days, 180 days and 1 year post procedure)
- Technical success(Intra-procedure)
- In-Stent Stenosis at 6 months post procedure(6 months post procedure)
- Complete aneurysm occlusion without significant parent artery stenosis (≤50%) or retreatment at 6 months post procedure(6 months post procedure)
- In-stent thrombosis at 6 months post procedure(6 months post procedure)
- Rate of Device defect(within 1 year of whole trial)
- Complete aneurysm occlusion at 6 months post procedure(6 months post procedure)
- Incidence of adverse events/serious adverse events during 30 days, 6 months and 1 year post procedure(30 days, 6 months and 1 year post procedure)
- Success aneurysm occlusion immediately after the procedure(Immediately after the procedure)
- Complete aneurysm occlusion or success aneurysm occlusion immediately after the procedure(Immediately after the procedure)
- Success aneurysm occlusion without significant parent artery stenosis (≤50%) or retreatment at 12 months post procedure(12 months post procedure)
- Complete aneurysm occlusion or success aneurysm occlusion at 12 months post procedure(12 months post procedure)
- Retreatment Rate at 6 months and 12 months post procedure(6 months, 12 months post procedure)
- In-Stent Stenosis at 12 months post procedure(12 months post procedure)
- Modified Rankin Scale (mRS) at 30 days, 6 months and 12 months post procedure(30 days, 6 months, 12 months post procedure)
- Major ipsilateral stroke or neurogenic death at 30 days, 6 months post procedure(30 days, 6 months post procedure)
- All-cause mortality at 30 days, 6 months and 12 month post procedure(30 days, 180 days and 12 months post procedure)
- Incidence of adverse events/serious adverse events during 30 days, 6 months and 12 month post procedure(30 days, 6 months and 12 months post procedure)
- In-stent thrombosis at 12 months post procedure(12 months post procedure)
- Rate of Device defect(within 12 months of whole trial)