NCT04870047进行中（未招募）不适用
Coating to Optimize Aneurysm Treatment In The New Flow Diverter Generation
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Phenox GmbH
- 入组人数
- 171
- 试验地点
- 34
- 主要终点
- Number of DWI lesions
研究概览
简要总结
To assess safety and efficacy of p64 MW HPC Flow Modulation Device under single antiplatelet therapy compared to p64 MW Flow Modulation Device under dual antiplatelet therapy.
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
- None
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
- •At least 18 years of age.
- •Subject has a saccular, unruptured or recanalized intracranial aneurysm. The subject may also have a previous ruptured aneurysm, provided rupture of this aneurysm 30 days from the index procedure.
- •Subject is intended to be treated for only one target aneurysm during the index procedure except for segmental disease (multiple aneurysms located on the same arterial segment aimed to be treated with one investigational device or investigational telescopic devices).
- •Subject has already been selected for flow diversion therapy as the appropriate treatment.
- •Subject has a mRS ≤ 2 before the procedure, as determined by a certified assessor independent of the index procedure.
- •Subject is able to understand the patient information and provides written informed consent verifying the use of his/her data (according to data protection laws).
排除标准
- •Subject who is currently prescribed under any long lasting antiplatelet and/or anticoagulation medication.
- •Subject has undergone a surgery including endovascular procedures in the last 30 days prior to the study procedure.
- •Subject has had an Intracranial hemorrhage and/or subarachnoid hemorrhage in the past 30 days prior to the study procedure.
- •Subject with target aneurysm previously treated with a stent or flow diverter.
- •Subject is expected to be treated for another aneurysm during the 30 days following the index procedure.
- •Subject with a confirmed stenosis in parent artery.
- •Subject with a blister-like aneurysm, fusiform aneurysm, dissecting aneurysm or aneurysm associated with a brain arteriovenous malformation (AVM).
- •Subject has a pre-procedure mRS >
- •Any known contraindication to treatment with the p64 MW HPC Flow Modulation Device in accordance with device IFU.
- •Subject who has undergone stenting of the ipsilateral carotid artery within 3 months of the index procedure.
- •Known serious sensitivity to radiographic contrast agents.
- •Known sensitivity to nickel, titanium metals, or their alloys.
- •Subject already enrolled in other clinical trials (including COATING study) that would interfere with study endpoints.
- •Known renal failure as defined by a serum creatinine > 2.5 mg/dl (or 220 μmol/l) or glomerular filtration rate (GFR) <
- •Subject who has a contraindication to MRI or angiography for whatever reason.
- •Subject with a comorbid disease or condition that would confound the neurological and functional evaluations or compromise survival or ability to complete follow-up assessments.
- •Subject with any known allergy to heparin, ASA or other antiplatelet medications.
- •Subject with coagulation disorder
- •Pregnant woman or breast feeding.
- •Adults who lack the capacity to provide informed consent, and all those persons deprived of their liberty in prisons or other places of detention.
研究组 & 干预措施
p64 MW HPC Flow Diverter + SAPT
Experimental
干预措施: Endovascular treatment of unruptured aneurysms with p64 MW HPC Flow Modulation Device (Device)
p64 MW Flow Diverter + DAPT
Experimental
干预措施: Endovascular treatment of unruptured aneurysms with p64 MW HPC Flow Modulation Device (Device)
结局指标
主要结局
Number of DWI lesions
时间窗: 48 hours (± 24 hours)
Number of diffusion-weighted imaging (DWI) lesions within 48 hours (+/- 24 hours) of the index procedure visualized via MRI.
次要结局
- Rate of subjects with dissusion-weighted imaging (DWI) lesions(48 hours (± 24 hours))
- Short-term morbi-mortality rate(30 days (± 7 days))
- Long-term morbi-mortality rate(180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure)
- Delayed aneurysm rupture(180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure)
- Delayed intraparenchymal hemorrhage(180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure)
- Rate of intrastent stenosis and/or thrombosis at the target site(180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure)
- Mean length of hospital stay(From admission up to discharge, assessed up to 456 days)
- Rate of neurological death or major stroke(180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure)
- Rate of peripheral bleeding(Any event reported from discharge to 365 days (335 - 456 days) post procedure)
- Rate of device deployment at the target site without technical complications(During intervention)
- Rate of complete aneurysm occlusion(180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure)
- Rate of target aneurysm retreatment(180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure)
- Rate of target aneurysm recurrence(180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure)
研究者
研究点 (34)
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