NCT02554708已完成不适用
pToWin pCONus Treatment of Wide Neck Intracranial Aneurysms
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Phenox GmbH
- 入组人数
- 116
- 试验地点
- 10
- 主要终点
- Effectiveness Aneurysm occlusion (complete or neck remnant)
研究概览
简要总结
To assess safety and efficacy of pCONus for the treatment of wide neck bifurcation aneurysms.
详细描述
Title: pCONus Treatment of Wide Neck Intracranial Aneurysms
Acronym: pToWin
Device: pCONus Bifurcation Aneurysm Implant
Study design: Prospective, multicenter, single-arm clinical investigation
Purpose: To assess safety and efficacy of pCONus for the treatment of wide neck bifurcation aneurysms
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
- •Aneurysm status:
- •Unruptured aneurysm or
- •Ruptured aneurysm with a Hunt and Hess grade of I - III.
- •Age ≥18 and ≤ 80 years.
- •The patient or legal representative provides written informed consent.
- •The patient shows general compliance to follow the medical regimen and to attend follow-up examinations.
- •The target aneurysm is located at one of the following cerebral vessel bifurcations: ICA terminus, AcomA, MCA or BA.
- •Bifurcation wide neck aneurysm.
- •The dome height should allow for safe deployment of the device crown. The fundus of the aneurysm should offer enough space for the crown of the pCONus to deploy.
排除标准
- •Vessel tortuosity precluding safe access and device deployment.
- •Stenosis within the vascular access or target vessel ≥ 50 %.
- •The target aneurysm has been previously treated with a stent or an intraaneurysmal implant beside coils.
- •The treatment plan for the target aneurysm includes the use of additional intra- and/or extraaneurysmal temporary or permanent implants other than coils.
- •More than one intracerebral aneurysm requires the treatment within the following 6 months.
- •Imaging evidence of an arteriovenous cerebrovascular malformation or a dural fistula.
- •Any physical, medical or psychiatric condition of the patient interfering with the adherence of the requirements and follow-up regimen of the study.
- •Any neurological disorder with progressive neurological symptoms, except attributable to a compressive effect of the target aneurysm.
- •Current involvement in another study or trial.
- •Women of child bearing potential or breast-feeding who cannot provide a negative pregnancy test.
- •Known allergy to the components of device, study medication or contrast media that cannot be controlled medically.
- •A medical condition interfering with a dual antiplatelet treatment.
- •Known coagulopathy.
- •Intracranial hemorrhage in the past 30 days apart from the target aneurysm.
- •Ischemic stroke in the past 30 days.
- •Myocardial infarction in the past 30 days.
- •Major surgery in the past 30 days.
- •Evidence of active infection at time of treatment.
- •Co -morbidities or conditions with a life expectancy less than 12 months.
- •Additional Exclusion criteria for ruptured aneurysm at the acute phase:
- •The patient is clinically severely affected (Hunt and Hess grade IV and V).
- •Severe vasospasm is proven during angiography.
- •Proven parenchymal hemorrhage by CT or MRI.
- •Proven subdural hematoma by CT or MRI.
结局指标
主要结局
Effectiveness Aneurysm occlusion (complete or neck remnant)
时间窗: Change from post-procedure to 3-6 and to 7-12 months
Safety Major stroke (ischemic or hemorrhagic) or neurological death related to the treatment of the target aneurysm
时间窗: within 12 months
次要结局
- Safety Intra-Procedural Complications(at the time of the procedure)
- Safety Post-Procedural Complications(Change 1day post procedure up to 12months)
- Effectiveness(at the time of the procedure)
研究者
研究点 (10)
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