NCT05544045终止不适用
Endovascular Treatment of Patients in China With the Surpass Streamline Flow Diverter for Unruptured Large and Giant Saccular Wide-Neck or Fusiform Intracranial Aneurysms in the Internal Carotid Artery
Stryker Neurovascular15 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2022年6月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 11
- 试验地点
- 15
- 主要终点
- Primary Efficacy Endpoint. Percentage of subjects with 100% occlusion (Raymond Class 1) without clinically significant stenosis defined as >50% stenosis of the parent artery
研究概览
简要总结
A multi-center, prospective, single-arm, non-randomized, post-market, observational study.
The primary objective of this study is to evaluate the long-term safety and efficacy of the Surpass Streamline Flow Diverter System (FDS) in the treatment of unruptured large and giant (≥ 10 mm) saccular wide-neck (neck width ≥ 4 mm) or fusiform intracranial aneurysms in the internal carotid artery from the petrous segment to the terminus arising from a parent vessel with a diameter ≥ 2.5 mm to ≤ 5.3 mm.
详细描述
The Surpass Streamline FDS is indicated for use in the endovascular treatment of adults (age 18 years or older) with unruptured large (≥ 10 mm) saccular, wide-neck (neck width ≥ 4 mm or dome/neck ratio < 2 mm) or fusiform intracranial aneurysms in the internal carotid artery from the petrous segment to the terminus arising from a parent vessel with a diameter ≥ 2.5 mm to ≤ 5.3 mm.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Subject age ≥ 18 and ≤ 80 years
- •Subject or legal authorized representative is willing and able to give informed consent
- •Subject has a single targeted intracranial aneurysm that:
- •Is located in the internal carotid artery (ICA) distribution from petrous segment up to the terminus
- •Is able to be crossed with a standard 0.014" guide wire
- •Has unruptured saccular wide-neck (neck width ≥ 4 mm or dome-to-neck ratio < 2) or fusiform intracranial aneurysms size ≥10 mm
- •Has a vessel diameter ≥ 2.5 mm to ≤ 5.3 mm at both the proximal and distal segments where the implant will be placed
- •Subject is willing to comply with all scheduled follow-up visits and examinations per institutional standard of care
排除标准
- •Subject has a major surgery within previous 30 days or planned in the next 120 days after enrollment date
- •Previous intracranial implant associated with the symptomatic distribution within the past 12 weeks prior to treatment date
- •Subject has a non-target aneurysm treated within 30 days prior to study enrollment and a non-target aneurysm that requires treatment within 12 months.
- •Subject has a planned treatment of a non-target aneurysm in the same vascular territory during participation in the study.
- •Stenting, angioplasty, or endarterectomy of an extracranial (carotid or vertebral artery) or intracranial artery within 30 days prior to treatment date
- •Any previous coiling where it would interfere with the placement and proper apposition of the device
- •More than one intracranial aneurysm that requires treatment within 12 months
- •Contraindication to CT or MRI scans
- •Subject has severe neurological deficit (mRS score ≥ 3) that renders the subject incapable of living independently
- •Dementia or psychiatric problem that prevents the subject from completing required follow-up
- •Co-morbid conditions that may limit survival to less than 24 months
- •Other known serious concurrent medical conditions such as heart disease (e.g., atrial fibrillation/pacemaker, recent myocardial infarction, symptomatic congestive heart failure, and significant carotid artery disease), pulmonary disease, uncontrolled diabetes, progressive neurologic disorders, vasculitis, or subjects using immunosuppressants including corticosteroids.
- •Female subjects who are pregnant or planning to become pregnant within the study period (all females of childbearing age must take a pregnancy test within 24 hours of treatment) and who are unwilling or unable to take adequate method of contraception for at least until the 12-month study follow-up*
- •*If the subject becomes pregnant during her participation, the physician will have to evaluate the risk associated to her continuing participation to the rest of the study.
- •Subject does not meet criteria or has any other contraindications listed in the DFU
- •Extra-cranial stenosis or parent vessel with stenosis >50% in the area proximal to the aneurysm
- •Subject with an intracranial mass (tumor, except meningioma, abscess, or other infection), or is undergoing radiation therapy for carcinoma or sarcoma of the head or neck region
- •Subject had a subarachnoid hemorrhage within 30 days prior to the enrollment date
- •Subject has a non-treated arterio-venous malformation (AVM) in the territory of the target aneurysm
- •Inability to understand the study or a history of non-compliance with medical advice
- •Current use of illicit substance
- •Enrollment in another trial involving an investigational product
结局指标
主要结局
Primary Efficacy Endpoint. Percentage of subjects with 100% occlusion (Raymond Class 1) without clinically significant stenosis defined as >50% stenosis of the parent artery
时间窗: 12 months
Subjects with 100% occlusion (Raymond Class 1) without clinically significant stenosis defined as \>50% stenosis of the parent artery based on independent angiographic core laboratory evaluation of 12-month follow-up angiograms and having no retreatment of the target aneurysm through the 12 month follow-up visit timepoint.
Primary Safety Endpoint. Percentage of subjects experiencing neurological death or major ipsilateral stroke in the treated vascular territory
时间窗: 12 months
Subjects experiencing neurological death or major ipsilateral stroke in the treated vascular territory through 12 months as adjudicated by an independent Clinical Events Committee (CEC).
次要结局
- Secondary Safety Endpoints. Percent of subjects experiencing one or more SAEs(60 months post-index procedure)
- Secondary Efficacy Endpoints. Surpass Streamline FDS technical success. The proportion of subjects in whom the Surpass Streamline implant(s) was delivered to cover the aneurysm neck.(Intraoperation)
- Secondary Efficacy Endpoints. Surpass Streamline FDS system success. The proportion of implants successfully delivered to the target location.(Intraoperation)
- Secondary Efficacy Endpoints. Re-sheathing performance. The percent and number of Surpass devices that are successfully re-sheathed will be reported.(Intraoperation)
- Secondary Efficacy Endpoints. Incidence of retreatment through 60 months. The percent and number of mITT subjects who require retreatment, either with the Surpass Streamline Flow Diverter system or with another approach.(60 months post-procedure)
- Secondary Efficacy Endpoints. The percent and number of mITT subjects who are recorded as having >50% stenosis of the parent artery at the target aneurysm location(60 months)
- Secondary Efficacy Endpoints. Functional status: change in the modified Rankin Scale (mRs) score compared to baseline. Percent of subjects who at follow-up exhibit improvement, worsening, or no change in their modified Rankin score compared to baseline.(60 months)
- Secondary Efficacy Endpoints.Proportion of subjects with Raymond Class 1, 2 and 3 occlusions.The percent and number of mITT subjects in each Raymond class level at 12 and 36 months will be reported.(12 and 36 months)
- Secondary Efficacy Endpoints. The percent and number of mITT subject who are recorded as having >50% stenosis of their flow diverter(60 months)
- Secondary Efficacy Endpoints.The percent and number of mITT subject with any contrast opacification within the treated and previously fully occluded aneurysm on a subsequent angiographic study(60 months post-procedure)
研究者
研究点 (15)
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