Hydrogel Balloon Assisted Intracranial Aneurysm Coiling Registry
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Aneurysm recurrence rate
研究概览
简要总结
The objective of the GELATIN registry is to prospectively evaluate intracranial aneurysm occlusion and retreatment rates as well as adverse event rates in patients undergoing balloon-assisted coiling using the MicroVention Scepter Occlusion Balloon Catheter and second-generation MicroVention hydrogel coils for treatment of previously treated or untreated ruptured and unruptured intracranial aneurysms.
详细描述
This is a prospective, single arm, single center study of patients with ruptured or unruptured saccular aneurysms that are embolized using MicroVention second-generation hydrogel coils and undergo balloon remodeling with the MicroVention Scepter Occlusion Balloon Catheter. Data for each patient will be collected 6 ± 3 months post-procedure for the study.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is 18-80 years of age.
- •Patient has a documented, previously treated or untreated saccular intracranial aneurysm, 4- 20 mm unruptured or ruptured, suitable for treatment with balloon assisted coil embolization.
- •Target aneurysm has a neck ≥4mm or the largest diameter to neck ratio of 2 or less.
- •Patient has a Hunt and Hess Score of 3 or less.
- •Patient has a premorbid mRS of 3 or less.
- •Patient or patient's legally authorized representative has provided written informed consent.
- •Patient is willing to and can comply with study follow-up requirements.
排除标准
- •Inability to obtain informed consent.
- •Patient is <18 or >80 years of age.
- •Target aneurysm is dissecting, fusiform, mycotic, or arteriovenous malformation-related.
- •Aneurysm that was treated previously with stent-assisted coiling.
- •Implantation of the stent after the balloon-assisted coiling or combined stent and balloon assisted coiling.
- •Target aneurysm is deemed unsuitable for balloon-assisted coiling by the treating physician prior to the procedure.
- •Target aneurysm will be treated with a total coil length comprised of less than 80% second generation MicroVention Hydrogel Coils.
- •Balloon-assisted coiling will be performed using a balloon catheter other than the MicroVention Scepter balloon (Scepter C, Scepter XC, any future Scepter configurations).
- •Patients in which the target aneurysm is planned not to be coiled in one procedure (i.e. staged procedure).
- •Patients with more than one aneurysm that requires treatment. (However, a second small low risk aneurysm that does not require therapy may be allowed.)
- •Patients with a life expectancy of ≤ 9 months.
结局指标
主要结局
Aneurysm recurrence rate
时间窗: 3-9 month follow-up
次要结局
- Number of coils used(At end of study procedure (Day 1))
- Aneurysm re-treatment rate(3-9 month follow-up)
- Modified Rankin Score(At baseline (Day 1) and hospital discharge (Day 3) and 3-9 month follow-up)
- Occlusion Rate(At immediate post-procedure (Day 1) and 3-9 month follow-up)
- Total coil length used(At immediate post-procedure (Day 1))
- Device-related serious adverse events(From the study procedure (Day 1) until 3-9 month follow up)
- Aneurysm Bleed and Re-bleed Rate(3-9 month follow-up)
- Time of fluoroscopic exposure(At immediate post-procedure (Day 1))