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Enrolling by Invitation

NCT Number: NCT06702787

Mechanical Thrombectomy in the Middle East and North Africa: Interim Results from the MEMENTO Registry

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.

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Key information

Conditions

Stroke Brain Diseases Brain Infarction Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebral Infarction Cerebrovascular Disorders Endovascular Procedures Infarction Ischemia Large Vessel Occlusion Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Acute Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Alexandria University Stroke network

Alexandria, Alexandria Governorate, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 0-5. Consent to participate in the registry (by patient or legal representative).

Exclusion criteria

Absence of confirmed LVO or MeVO. Pre-stroke mRS score of 6. Known severe comorbid conditions precluding MT. Inability to obtain informed consent. Patients not treated with MT.

Treatment and study plan

Primary outcomes

  1. Functional Independence at 90 Days

    Time frame: 90 days post-procedure

    Description: Proportion of patients achieving a modified Rankin Scale (mRS) score of 0-2 at 90 days post-procedure.

Secondary outcomes

  1. Proportion of Patients Achieving TICI Score ≥2b After MT

    Time frame: Immediately post-procedure

    Proportion of patients achieving Thrombolysis in Cerebral Infarction (TICI) score ≥2b after MT.

    Scale Title: Thrombolysis in Cerebral Infarction (TICI) score Scale Range: 0 to 3 Outcome Interpretation: Higher scores indicate better outcomes, with a score of ≥2b representing successful reperfusion.

  2. Improvement in NIHSS Score from Baseline to 24 Hours and at Follow-up

    Time frame: Baseline, 24 hours, and up to 90 days

    Improvement in National Institutes of Health Stroke Scale (NIHSS) score from baseline to 24 hours and at follow-up.

    Scale Title: National Institutes of Health Stroke Scale (NIHSS) Scale Range: 0 to 42 Outcome Interpretation: Lower scores indicate better outcomes, with a decrease in score representing improvement in stroke symptoms.

  3. Symptomatic Intracerebral Hemorrhage (sICH) Rate

    Time frame: Within 7 days post-procedure

    Incidence of symptomatic intracerebral hemorrhage (sICH) in patients post-mechanical thrombectomy (MT), defined according to the European Cooperative Acute Stroke Study III (ECASS III) criteria. sICH is identified when there is:

    Imaging Evidence: Any intracerebral hemorrhage (ICH) detected on neuroimaging (computed tomography [CT] scan or magnetic resonance imaging [MRI]).

    Clinical Deterioration: A neurological worsening characterized by an increase of ≥4 points in the National Institutes of Health Stroke Scale (NIHSS) score from baseline or leading to death.

  4. All-Cause Mortality at 90 Days

    Time frame: 90 days post-procedure

    Proportion of patients who have died from any cause by 90 days post-procedure.

  5. Complication Rate

    Time frame: Immediately post-procedure up to 7 days

    Incidence of procedure-related complications (e.g., arterial dissection, vessel perforation).

  6. Incremental Cost-Effectiveness Ratio (ICER) per Quality-Adjusted Life Year (QALY) Gained

    Time frame: From baseline (pre-procedure) through 90 days post-procedure, with economic modeling extended to a lifetime horizon (up to 20 years)

    The cost-effectiveness of mechanical thrombectomy (MT) compared to standard medical care (SMC) will be assessed by calculating the Incremental Cost-Effectiveness Ratio (ICER). This involves measuring both costs and health outcomes:

    Costs: Using hospital billing records and resource utilization data. Effectiveness: Measuring QALYs using the EQ-5D-5L questionnaire, a standardized instrument for measuring health outcomes.

    ICER Calculation: Explaining that the ICER will be calculated by dividing incremental costs by incremental QALYs.

Sponsors and collaborators

Lead sponsor

Middle East North Africa Stroke and Interventional Neurotherapies Organization

Other

Registry information

Acronym: MEMENTO Regist

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Nov 25, 2024
Registry last updated
Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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