EffectiveNess and SAfety of Small ANeurysm COiling Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 252
- 试验地点
- 19
- 主要终点
- Procedural failure
研究概览
简要总结
To compare the safety and efficacy of treating small aneurysms with coils specially designed for small aneurysms to historically reported rates of safety and efficacy for the treatment of larger aneurysms.
详细描述
This is a prospective cohort study whereby patients who undergo endovascular treatment with coils for intracranial aneurysms will be studied for initial procedural and 12-18 month post-treatment outcome. The procedural failure rate (defined above) of treating small aneurysms with specially designed coils will be compared to pre-specified historical occurrences. This evaluation will occur within the framework of "non-inferiority" (i.e. comparable success to coiling of large 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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient presenting with a ruptured or un-ruptured cerebral aneurysm appropriate for endovascular treatment as determined by the neurovascular team (neurosurgeon/neurointerventionalist)
- •Patients between (and including) 18 and 90 years of age.
- •Patient HUNT AND HESS Grade 0-
- •Where required, patient has given fully informed consent to endovascular coiling procedure. If patient cannot consent for themselves, appropriate written consent has been sought from their surrogate, or from appropriate power of attorney.
- •Aneurysm < 4mm in maximum diameter.
- •Patient is willing and able to return for clinical evaluation and follow-up imaging evaluation (angiography or MRA) at both 6-months and 12-18 months after endovascular treatment.
- •The aneurysm has not previously been treated (by coiling or clipping).
- •A three-dimensional angiogram has been performed.
- •Placement of at least one "Nano" coil, at, or at least close to the neck of the aneurysm.
排除标准
- •Patient has more than one aneurysm requiring treatment in the current treatment session. If a patient has multiple aneurysms, but only one will be treated at the time of enrollment, they are eligible for the trial. (Additional aneurysms may be treated at a later date, and may be treated with any coil type that the operator chooses).
- •Patient has an H&H score of 4 or 5 after subarachnoid hemorrhage (SAH).
- •Medical or surgical co-morbidity such that the patient's life expectancy is less than 1 year.
- •Less than 80% by length of Stryker endovascular coils are implanted.
结局指标
主要结局
Procedural failure
时间窗: 18 Months
Defined as the composite of technical failure (inability to coil the aneurysm), and complication leading to permanent neurologic injury or death. The second primary outcome relates to the long term effectiveness of the procedure, and is defined as freedom from angiographic recurrence within a period of 12-18 months after the index procedure.
次要结局
未报告次要终点
研究者
Avery Evans, MD
Professor, Department of Radiology
University of Virginia