Post-Approval Study - Post-Market Surveillance Study to Evaluate the Long-Term Safety and Effectiveness of the LVIS® Device
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Transient Ischemic Attack
研究概览
简要总结
The proposed study is a multi-center single arm retrospective and prospective data collection, of patients treated with the LVIS device of specific sizes of 3.5mm, 4.0mm, 4.5mm, 5.5mm with up to 5 years follow-up. Information collected during the study will be standardized across centers to include pre-treatment baseline characteristics of patients including aneurysm(s) symptoms, procedural information, prespecified clinical safety events of interest, and follow-up imaging, clinical visits or telephone calls.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The following criteria match the FDA-approved indications for use per PMA (P170013)
- •Subjects treated with the LVIS® Device in accordance with currently approved indications for use;
- •Treatment of wide-necked (neck ≥ 4mm or dome to neck ratio < 2) intracranial saccular aneurysm arising from a parent vessel with a diameter ≥ 2.0 mm and ≤ 4.5 mm who underwent treatment with LVIS device of researched sizes within the last 5 years.
- •(Device models: 212517-LVIS, 212525-LVIS, 213015-LVIS, 213025-LVIS, 213041-LVIS, 214035-LVIS, 214049-LVIS; 212912-LVIS, 212917-LVIS, 212922-LVIS, 212928-LVIS, and 212931-LVIS);
- •Availability of Medical Health Records;
- •Subject whose age is ≥ 18;
- •Appropriate or Waived Consent:
- •For retrospective review: Local Institutional Review Board approves the research as exempt, allowing an all-inclusive retrospective examination of medical records documenting treatments using the study devices and available clinical and imaging follow up;
- •For prospective follow up: Subject or his/her Legally Authorized Representative consents to participation in the study follow up visits up to 5 years, and provides a signed informed consent form as applicable;.
排除标准
- •Subjects not treated according to the currently approved indications for use
结局指标
主要结局
Transient Ischemic Attack
时间窗: 5 year
Determined by adverse event adjudication by the clinical events committee
Cerebral vasospasm
时间窗: 5 year
Presented by the subject medical records
Intracranial hemorrhage including SAH and IPH
时间窗: 5 year
Determined by adverse event adjudication by the clinical events committee
Neurological deaths
时间窗: 5 year
Determined by adverse event adjudication by the clinical events committee
Complete or Stable Raymond Roy II
时间窗: 5 year
The Raymond-Roy occlusion classification (RROC) is an angiographic classification scheme for grading the occlusion of endovascularly treated intracranial aneurysms. It is also known as the Raymond class, Montreal scale or the Raymond Montreal scale
All ischemic and hemorrhagic stroke
时间窗: 5 year
Determined by adverse event adjudication by the clinical events committee
In-stent stenosis
时间窗: 5 year
Determined by the corelab adjudication of images
Parent artery patency
时间窗: 5 year
Determined by the corelab adjudication of images
Target aneurysm retreatment
时间窗: 5 year
Presented by the subject medical records
次要结局
未报告次要终点