ROSSETTI: Registry of Combined vs Single Thrombectomy Techniques
试验速览
- 阶段
- 不适用
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Clinical Outcome
研究概览
简要总结
The ROSSETTI registry is an ongoing investigator-initiated prospective study recruiting deidentified demographic, clinical presentation, site-adjudicated angiographic, procedural, and outcome data in acute ischemic stroke (AIS) consecutive patients treated with mechanical thrombectomy (MT) across 10 Comprehensive Stroke Centers in Spain. The registry started in June 2019 and therefore incorporates the more recent device technology
详细描述
The study inclusion criteria are the following: age ≥18 years; confirmed large vessel occlusion (LVO) in the anterior circulation (intracranial internal carotid artery M1, proximal M2 segments, time from last seen well to treatment (TLSWT) <24 hours, baseline National Institutes of Health Stroke Scale (NIHSS) score ≥2, and premorbid modified Rankin Scale (mRS) score ≤2. All participating centers received institutional review board approval from their respective institutions and patients or representatives signed informed consent. The study data are collected prospectively through an online questionnaire. Type of stent-retriever , as long as European Community approved, is at the discretion of the operator.
The primary clinical outcome is the rate of excellent clinical outcome, defined as mRS score 0-1 at 90 days (no or minor symptoms but no functional limitations).[28] The primary technical outcome is the rate of first pass effect (FPE) defined as achieving near-complete/complete revascularization [modified Thrombolysis in Cerebral Infarction (mTICI 2c-3)] after single-device and single-pass approach
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
- •age ≥18 years;
- •confirmed large vessel occlusion in the anterior circulation (intracranial internal carotid artery, M1segment of middle cerebral artery, proximal M2 segment of middle cerebral artery
- •time from last seen well to treatment (TLSWT) <24 hours,
- •baseline National Institutes of Health Stroke Scale (NIHSS) score ≥2,
- •premorbid modified Rankin Scale (mRS) score ≤2.
排除标准
- •No evidence vessel occlusion.
- •Extra and Intracranial occlusion or severe stenosis.
- •Low platelets (100 x 10000) or impaired function,
- •Contraindication of computed tomography or magnetic resonance
- •Allergy to iodinated contrast non treatable medically,
- •pregnant or breast feeding patient,
- •hemorrhagic stroke on computed tomography or Magnetic Resonance
结局指标
主要结局
Clinical Outcome
时间窗: 3 months after thrombectomy
modified Rankin Score, 0 to 6, higher scores mean a worse outcome
Technical Outcome
时间窗: 1 day, revascularization grade will be assessed
Thrombolysis in Cerebral Infarction Scale, 0 to 3, higher scores mean a better outcome
次要结局
未报告次要终点