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StrokeMEMENTO RegistNCT06702787

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

An observational study of Stroke and Stroke Acute, run by Middle East North Africa Stroke and Interventional Neurotherapies Organization at 1 site in Egypt.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Any age
Conditions the study is for
Stroke, Stroke Acute, Endovascular Procedures
How many people
1,500 participants
Where
1 siteEgypt
Study dates
11 Mar 2022to 11 Sep 2025
How long will I take part?
90 Days
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Consecutive patients presenting with acute ischemic stroke due to LVO or MeVO at participating centers in the MENA region, who received MT as part of standard clinical practice.

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Egypt1 site
  • Alexandria University Stroke network

    Alexandria, Alexandria Governorate

Other trials in Egypt

About this study

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.

Read the detailed description

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.

Keywords
Mechanical Thrombectomy, Acute Ischemic, Stroke Large Vessel Occlusion, Middle East and North Africa MENA Region, Endovascular Treatment, Cerebral Infarction, Brain Ischemia, Stroke Management, Reperfusion Therapy, Neurointervention Cerebrovascular
Medical subject headings
Stroke, Cerebral Infarction, Brain Ischemia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Functional Independence at 90 Days

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

    Measured: 90 days post-procedure

Secondary outcomes (6)
  1. Proportion of Patients Achieving TICI Score ≥2b After MT

    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.

    Measured: Immediately post-procedure

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

    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.

    Measured: Baseline, 24 hours, and up to 90 days

  3. Symptomatic Intracerebral Hemorrhage (sICH) Rate

    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.

    Measured: Within 7 days post-procedure

  4. All-Cause Mortality at 90 Days

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

    Measured: 90 days post-procedure

  5. Complication Rate

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

    Measured: Immediately post-procedure up to 7 days

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

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2024
  2. Study start11 Mar 2022
  3. Primary completion11 Apr 2025 (estimated)
  4. Study completion11 Sep 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,500 participants (estimated)
Target duration
90 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT06702787
Sponsor's protocol ID
MENASINO1002
Acronym
MEMENTO Regist
Status last verified
Nov 2024
First submitted
14 Nov 2024
Last updated
25 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke and Stroke Acute, run by Middle East North Africa Stroke and Interventional Neurotherapies Organization at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional Independence at 90 Days (time frame: 90 days post-procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.

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