A Prospective, Multicenter, Randomized Controlled Trial to Evaluate the Safety and Effectiveness of the SINOMED IAS for the Treatment of Intracranial Aneurysms
概览
- 阶段
- 不适用
- 干预措施
- SINOMED IAS Stent System
- 疾病 / 适应症
- Intracranial Aneurysm
- 发起方
- Sinomed Neurovita Technology Inc.
- 入组人数
- 203
- 试验地点
- 1
- 主要终点
- Success aneurysm occlusion at 6 month post procedure
- 状态
- 已完成
- 最后更新
- 上个月
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 endpoint is the incidence of success aneurysm occlusion at 6-month post procedure. All patients will have clinical follow-up during intraoperative, 30 days, 6 months, 1 year.
研究者
入排标准
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.
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
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
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.
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)