Mechanical Thrombectomy in the Middle East and North Africa: Interim Results from the MEMENTO Registry
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Functional Independence at 90 Days
研究概览
简要总结
The MEMENTO (MEchanical thrMobectomy NETwork for MENA TOgether) Registry is a multicenter, prospective observational study aiming to evaluate the effectiveness, safety, and cost-effectiveness of mechanical thrombectomy (MT) in patients with acute ischemic stroke (AIS) due to large vessel occlusions (LVO) in the Middle East and North Africa (MENA) region. This interim analysis reports on the first 499 patients enrolled, assessing clinical outcomes, procedural details, and economic implications.
详细描述
Detailed Description Stroke is a leading cause of morbidity and mortality worldwide, with a significant burden in the MENA region due to limited access to advanced stroke care therapies like mechanical thrombectomy (MT). The MEMENTO Registry seeks to collect real-world data on MT practices, outcomes, and accessibility in the MENA region to inform clinical practice and policy. The study includes AIS patients who underwent MT for confirmed LVO or medium vessel occlusion (MeVO), with or without prior intravenous thrombolysis (IV tPA), regardless of age, baseline NIHSS score, or time from symptom onset.
Data collected encompass demographics, clinical characteristics, imaging findings, procedural details, outcomes at discharge and follow-up, complications, and a cost-effectiveness analysis comparing MT to standard medical care (SMC). The primary outcome is functional independence at 90 days post-procedure, defined as a modified Rankin Scale (mRS) score of 0-2.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years and older (no upper age limit). Diagnosed with acute ischemic stroke due to confirmed large vessel occlusion (LVO) or medium vessel occlusion (MeVO).
- •Underwent mechanical thrombectomy (MT) with or without prior intravenous thrombolysis (IV tPA).
- •Pre-stroke modified Rankin Scale (mRS) score of 0-
- •Consent to participate in the registry (by patient or legal representative).
排除标准
- •Absence of confirmed LVO or MeVO. Pre-stroke mRS score of
- •Known severe comorbid conditions precluding MT. Inability to obtain informed consent. Patients not treated with MT.
结局指标
主要结局
Functional Independence at 90 Days
时间窗: 90 days post-procedure
Description: Proportion of patients achieving a modified Rankin Scale (mRS) score of 0-2 at 90 days post-procedure.
次要结局
- Proportion of Patients Achieving TICI Score ≥2b After MT(Immediately post-procedure)
- Improvement in NIHSS Score from Baseline to 24 Hours and at Follow-up(Baseline, 24 hours, and up to 90 days)
- Symptomatic Intracerebral Hemorrhage (sICH) Rate(Within 7 days post-procedure)
- All-Cause Mortality at 90 Days(90 days post-procedure)
- Complication Rate(Immediately post-procedure up to 7 days)
- Incremental Cost-Effectiveness Ratio (ICER) per Quality-Adjusted Life Year (QALY) Gained(From baseline (pre-procedure) through 90 days post-procedure, with economic modeling extended to a lifetime horizon (up to 20 years))