Emergent Microsurgical Intervention in Acute Stroke Patients After Mechanical Thrombectomy Failure Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Clinical status at 3 month measured using modified Rankin score
研究概览
简要总结
With all of the gains that have been achieved with endovascular mechanical thrombectomy revascularization and intravenous thrombolysis logistics, there is still a subgroup of patients with salvageable brain tissue for whom persistent emergent large vessel occlusion (ELVO) portends a catastrophic outcome. Study aims to test the safety and efficacy of emergent microsurgical intervention in acute ischemic stroke patients with symptomatic middle cerebral artery occlusion after failure of mechanical thrombectomy.
详细描述
Randomization: Patients after mechanical thrombectomy failure at the first Comprehensive Stroke center (Center 1) will be randomly allocated to the microsurgery group (MSIG) or standard of care Control group 1 (CG1) with 1 : 1 randomization ratio. All consecutive patients with standard stroke care and recanalization failure after mechanical thrombectomy without any subsequent surgical interventions at the second Comprehensive Stroke center (Center 2) will be included in the Control group 2 (CG2) to support reproducibility and eliminate bias in patient selection for MSI - case-control.
Demographics (age, sex) and medical history (arterial hypertension; diabetes mellitus; hyperlipidemia; body mass index; previous stroke or transient ischemic attack; ischemic heart disease; atrial fibrillation; smoking; alcohol abuse; previous use of antithrombotics, anticoagulants, and statins; glucose and cholesterol level at admission; and blood pressure at admission) data will be collected in all patients at admission.
The neurological status will be assessed using the National Institute of Health Stroke Scale (NIHSS) score at admission and 24 h and seven days after stroke onset.
Collected data for clinical outcomes include modified Rankin score (mRS) 24 h and 90 days after stroke onset, 7- and 90-day mortality, and incidence of symptomatic intracerebral hemorrhage (SICH).
SICH is defined as type 2 parenchymal hematoma and clinical worsening with an NIHSS score of ≥ 4.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •age of ≥ 18 years;
- •indication for MT according to valid guidelines;
- •modified Rankin score (mRS) of ≤ 2 before stroke onset;
- •baseline Alberta Stroke Program Early CT Score (ASPECTS) of ≥ 6;
- •MCA occlusion in M1 or M2 segment with or without intracranial ICA occlusion;
- •estimated onset-to-skin cut time of ≤6 h or core/penumbra mismatch in cases with wake-up stroke or stroke with unknown onset;
- •MT failure with TICI score of 0-1 declared by an interventional neuroradiologist and expectation to achieve recanalization within 24 h from stroke onset.
排除标准
- •indication for MT according to valid guidelines;
- •thrombocyte count of ≤ 100,000/µL;
- •contraindication for general anesthesia
结局指标
主要结局
Clinical status at 3 month measured using modified Rankin score
时间窗: 90 days after randomization
modified Rankin score range: 0-6; favourable clinical outcome: modified Rankin score 0-2; percentage of patients with favourable clinical outcome
次要结局
- Mortality(90 days after randomization)
- Clinical status at 24 hours measured using modified Rankin score(24 hours after randomization)
- Percentage of patients with symptomatic intracerebral hemorrhage(24 hours after randomization)