RECANALISATION THERAPY IN ISCHEMIC STROKE DUE TO BASILAR ARTERY OCCLUSION IN PEOPLE 115 HOSPITAL, VIETNAM
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- favourable outcome
研究概览
简要总结
Rationale: Recently, two prospective multicenter RCT reported a potential beneficial effect of endovascular thrombectomy (EVT) in patients with an acute symptomatic basilar artery occlusion (BAO). However, the high rate of crossover in BEST study and the long-term of recruitment in BASICS study influenced the validity of the results.
Objective: To assess the outcomes and prognostic factors of recanalization therapy in patients with BAO, caused by a CTA/MRA/DSA confirmed occlusion of the basilar artery.
Study design: This is a prospective observational study. Study population: Patients with acute ischemic stroke and a confirmed basilar artery occlusion by CTA/MRA/DSA.
Main study parameters/outcomes: Favorable outcome at day 90 defined as a modified Rankin Score (mRS - functional scale) of 0-3. The estimate will be adjusted for the known prognostic variables age, time from onset to treatment, stroke severity (NIHSS), PC ASPECT and collateral flow and adjusted and unadjusted estimates with corresponding 95% confidence intervals will be reported.
详细描述
Acute basilar artery thrombosis is associated with a poor prognosis. Prevalence of basilar artery occlusion are not known in Vietnam.Various treatments were tried in groups of patients with acute ischemic stroke due to basilar artery occlusion, but evidence based was not cleared previous studies. Therefore, we conduct this study to evaluate the efficacy and safety of recanalization therapies, which included intravenous thrombosis alone, endovascular alone, or bridging IVT and endovascular, in basilar artery occlusion stroke patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptoms and signs compatible with ischemia in the basilar artery territory.
- •Basilar artery occlusion (BAO) confirmed by CTA or MRA or DSA.
- •Age 18 years or older
- •Patients were treated with one of these among therapies IVT alone, bridging IVT and thrombectomy or thrombectomy alone..
排除标准
- •Patients did not agree to enroll.
- •Imaging exclusion criteria:
- •High-density lesion consistent with hemorrhage of any degree
- •Significant cerebellar mass effect or acute hydrocephalus
结局指标
主要结局
favourable outcome
时间窗: 90 (± 14 days) after procedure
a modified Rankin Score of 0-3
次要结局
- Any intracerebral hemorrhage(within 72 hours after procedure)
- Symptomatic intracerebral hemorrhage (sICH)(within 72 hours after procedure)
- Dichotomized mRS score(90 (± 14 days) after procedure)
- Procedural related complications(Perioperative period)
- good outcome(90 (± 14 days) after procedure)
- mortality(90 (± 14 days) after procedure)
研究者
NGUYEN THI BICH HUONG
Investigator
115 People's Hospital