Prospective, Multi-Center, Single-Arm Study of Reverse Medical Barrel™ Vascular Reconstruction Device for Adjunctive Treatment to Embolic Coils in Wide-Neck, Intracranial, Bifurcating Aneurysms of Middle Cerebral and Basilar Arteries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 138
- 试验地点
- 6
- 主要终点
- Number of Participants With Neurologic Death or Major Ipsilateral Stroke Within 12 Month Follow-up Period.
研究概览
简要总结
Single arm study to evaluate the outcomes of treatment with the Barrel VRD device as an adjunctive treatment to coiling for wide neck, intracranial, bifurcating/branching aneurysms in the middle cerebral and basilar arteries.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female between 18 and 85 years old.
- •A wide-neck de novo or non-de novo aneurysm.
- •Appropriate informed consent obtainable as determined by local IRB.
- •Life expectancy > 24 months.
排除标准
- •Aneurysm rupture within 30 days of enrollment.
- •Bifurcating aneurysms not treatable with coiling.
- •Subject has platelet count of <70,
- •Subject has known allergies to nickel-titanium metal.
- •Subject has known allergies to aspirin or heparin.
- •Subject has a life-threatening allergy to contrast (unless treatment for allergy can be tolerated).
- •Subject is currently participating in another clinical research study.
- •Subject is pregnant or breastfeeding.
- •Subject has participated in a drug study within the last 30 days.
- •Subject is unable or unwilling to comply with protocol requirements and obtain required clinical evaluations and follow-up.
研究组 & 干预措施
BARREL VRD
The Barrel VRD was implanted as adjunctive to embolic coils in subjects with wide necked bifurcating aneurysms within the Middle Cerebral and Basilar Arteries.
干预措施: BARREL VRD (Device)
结局指标
主要结局
Number of Participants With Neurologic Death or Major Ipsilateral Stroke Within 12 Month Follow-up Period.
时间窗: 12 months, after device implant
The primary safety endpoint was the number of participants reported with a neurological death or major ipsilateral stroke (National Institute of Stroke Scale (NIHSS) increase of ≥ 4 for \> 24 hours) at any time during the follow-up period. The NIHSS is a tool used to quantify neurological impairment caused by stroke. The scale interpretation is as follows: 0: No stroke symptoms 1-4: Minor stroke symptoms 5-15: Moderate stroke 16-20: Moderate to severe stroke 21-42: Severe strokeThe National Institutes of Health Stroke Scale
Number of Participants With Raymond Grade I ( 100%) Occlusion of the Aneurysms for Participants Treated With the Barrel VRD at 12 Months in the Absence of Retreatment, Parent Artery Stenosis, or Target Aneurysm Rupture
时间窗: 12 months, after device implant
The primary effectiveness endpoint was the count of participants achieving Raymond Grade I (100% occlusion) of the aneurysm treated with the Barrel VRD at 12 months ± 8 weeks in the absence of retreatment, parent artery stenosis (\>50%), or target aneurysm rupture The Raymond Grade Classification definitions evaluated by an independent core laboratory are as follows: Class 1: Complete occlusion - complete obliteration of the aneurysm. Class 2: Residual neck - persistence of any portion of the original defect of the arterial wall as seen on any single projection, but without opacification of the aneurysmal sac. Class 3: Residual aneurysm - opacification of the aneurysmal sac
次要结局
- Number of Participants With Successfully Deployed Barrel VRD(Index Procedure, Day 0)
- Number of Participants With Raymond Grade I (100% Complete Occlusion) and Raymond Grade II (Residual Neck) for Participants Treated With the Barrel VRD, in the Absence of Retreatment, Parent Artery Stenosis (>50%), or Target Aneurysm Rupture at 12 Months(12 months, after device implant)
- Number of Participants With Angiographic Evidence of In-stent Stenosis at 12 Months +/- 8 Weeks Reported According to the Following Ordinal Groups: <25%, 25-50%, 51-75%, >75%(At 12 Months +/- 8 weeks)
- Number of Participants With Modified Rankin Score of 0-2 or no Change From Baseline(12 months, after device implant)
- Number of Participants With Any Cause of Death Within 30 Days or Neurological Death Within 12 Months +/- 8 Weeks(30 Days and 12 months +/- 8 weeks)