Multi-center Non-randomized Clinical Investigation of the Reverse Medical Barrel™ Vascular Reconstruction Device (VRD) for Adjunctive Treatment to Embolic Coils for Wide Neck Intracranial Bifurcation and Branch Aneurysms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Successful aneurysm occlusion with the Barrel™ VRD, as measured by angiography with an aneurysm Raymond Grade Scale of 1 or 2 at 12 months post procedure
研究概览
简要总结
The purpose of this clinical investigation is to evaluate the safety and effectiveness of the Barrel™ VRD when used to facilitate endovascular coiling of wide-neck bifurcating or branch intracranial aneurysms with any approved embolic coils.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Summary Inclusion Criteria:
- •Male or female ≥18 years old.
- •A wide neck, intracranial, bifurcating or branch aneurysm with a neck ≥4 mm or a dome-to-neck ratio <2, including non-de novo aneurysms where no stent was utilized.
- •Subject's aneurysm arises from a parent vessel with a diameter ≥ 2.0 mm and ≤ 4mm, measured by 2D Digital Subtraction Angiography (DSA).
- •Subject responds to anti-coagulation and anti-platelet therapy according to the test used in each study center.
- •Subject is eligible to undergo a procedure with the use of contrast media.
- •Subject is willing to comply with protocol requirements and return to the treatment center for all required clinical evaluations and follow-up.
- •Subject has given written informed consent.
- •Life expectancy > 12 months.
排除标准
- •Subject presents with ruptured aneurysm, unless rupture occurred 30 days or more prior to screening.
- •Subject is currently undergoing radiation therapy.
- •Subject has known allergies to nickel-titanium metal.
- •Subject has known allergies to aspirin, heparin, ticlopidine, or clopidogrel.
- •Subject has a life-threatening allergy to contrast media (unless treatment for allergy can be tolerated).
- •Subject has a known cardiac disorder, likely to be associated with cardio-embolic symptoms such as atrial fibrillation (AFIB).
- •Subject has any condition, which in the opinion of the treating physician, would place the subject at a high risk of embolic stroke.
- •Subject is currently participating in another clinical research study.
- •Subject has had a previous intracranial stenting procedure associated with the target aneurysm.
- •Subject is unable to complete the required follow-up.
- •Subject is pregnant or breastfeeding.(Females of childbearing potential must have a pregnancy test and provide written proof that they are not pregnant prior to inclusion.)
- •Subject has participated in a drug study within the last 30 days.
- •Subject who cannot or is unwilling to take ASA/Clopidogrel for a minimum of at least 3 months following the procedure.
- •Extradural aneurysms.
研究组 & 干预措施
Intracranial Aneurysm Treatment
Barrel™ Vascular Reconstruction Device (VRD) is Intended for use with embolic coils for the treatment of wide-neck bifurcating or branch intracranial aneurysms arising from a parent vessel with a diameter of ≥ 2.0 mm and ≤ 4 mm, measured by 2D Digital Subtraction Angiography (DSA). Wide-neck is defined as having a neck width ≥ 4 mm or a dome-to-neck ratio < 2.
干预措施: Barrel™ Vascular Reconstruction Device (VRD) (Device)
结局指标
主要结局
Successful aneurysm occlusion with the Barrel™ VRD, as measured by angiography with an aneurysm Raymond Grade Scale of 1 or 2 at 12 months post procedure
时间窗: 12 months
Effectiveness measures are successful aneurysm treatment with the Barrel™ VRD, as measured by angiography with an aneurysm Raymond Grade Scale of 1 or 2 at 12 months post procedure in the absence of retreatment, parent artery stenosis (\> 50%), or target aneurysm rupture. Safety measures are the absence of neurological death or major stroke at 12 months post treatment.
次要结局
- Successful delivery of the device measured by technical success.(At implant up to 30 days)