Clinical Evaluation of the p64 MW HPC and the p48 MW HPC Flow Diverters in an Observational Registry
试验速览
- 阶段
- 不适用
- 发起方
- Phenox GmbH
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Safety endpoint
研究概览
简要总结
The purpose of this study is to assess safety and effectiveness of the p64 MW HPC or p48 MW HPC Flow Modulation Device under Dual Antiplatelet Medication.
详细描述
Title: Observational Registry With p64 MW HPC and p48 MW HPC in Unruptured Anterior Circulation Aneurysms Under Dual Antiplatelet Medication.
Purpose: To assess safety and effectiveness of p64 MW HPC or p48 MW HPC under Dual Antiplatelet Medication in consecutive patients with unruptured anterior circulation aneurysms.
Follow-up intervals: Independent follow-ups (after 3 to 6 months and after 12 months and after 24 months) according to site specific standard.
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
- •At least one unruptured sidewall aneurysm in the anterior circulation
- •No implant (e.g., stent) in the target vessel segment
- •Age >18 years and <80 years
- •Not pregnant and in women of childbearing age, on oral contraception for two years following the procedure
- •No participation in another trial
- •No concomitant disease limiting the life expectancy to <2 years
- •No allergy to non-ionic contrast medium or to ASA and P2Y12 receptor antagonists
- •No other neurovascular disorder in the same vascular territory requiring treatment in the foreseeable future
- •Ability and willingness to comply with the medication requirements within the study,
- •Ability to understand the goal and risks of this study.
排除标准
- •Intracranial aneurysm considered not suitable for FD using p64 MW HPC or p48 MW HPC.
- •Aneurysm previously treated with a device in the parent vessel (e.g., stent, flow diverter).
- •Another intracranial procedure scheduled for the following 6 months.
- •Age < 18 years and > 80 years.
- •Pregnancy possible or confirmed. Patient not able or willing to arrange contraception for 12 months after treatment.
- •Patient not able or willing to adhere to the study protocol.
- •Patient not able or willing to undergo the scheduled follow-up examinations.
结局指标
主要结局
Safety endpoint
时间窗: Within 30 days after the intervention
Occurence of ischemic or hemorrhagic stroke. Incidence of ischemic or hemorrhagic stroke in the territory supplied by the treated artery.
次要结局
- Safety endpoint(Within the first 12 months after the intervention)