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.
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
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.
- Conditions
- Stroke, Stroke Acute, Endovascular Procedures, Large Vessel Occlusion
- 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.
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)
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
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
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
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
Complication Rate
Incidence of procedure-related complications (e.g., arterial dissection, vessel perforation).
Measured: Immediately post-procedure up to 7 days
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.
- First posted25 Nov 2024
- Study start11 Mar 2022
- Primary completion11 Apr 2025 (estimated)
- Study completion11 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Middle East North Africa Stroke and Interventional Neurotherapies Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ossama yassin MANSOUR, MD, PhD,, Principal investigator, Alexandria Universityfarouk Hassan, MD,Phd, Principal investigator, cairo university, EgyptAtila Oscan Ozdimar, MD, PhD, Principal investigator, Eskisehir Osmangazi UniversitySyed Irteza Hussain, MD, Principal investigator, Cleveland Clinic Abu DhabiFaisal Alghamdi, MD, Principal investigator, King Abdullah Medical CityNadia Hammami, MD, Principal investigator, institut National de Neurologie
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanical Thrombectomy in the Middle East and North Africa: Interim Results from the MEMENTO Registry
- ClinicalTrials.gov ID
- NCT06702787
- Acronym / sponsor ID
- MEMENTO Regist / MENASINO1002
- Conditions
- Stroke, Stroke Acute, Endovascular Procedures, Large Vessel Occlusion
- Keywords
- Mechanical Thrombectomy, Acute Ischemic, Stroke Large Vessel Occlusion, Middle East and North Africa MENA Region, Endovascular Treatment, Cerebral Infarction, Brain Ischemia, Stroke Management
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Middle East North Africa Stroke and Interventional Neurotherapies OrganizationUniversity, hospital or other
- Study start
- 11 Mar 2022 (actual)
- Primary completion
- 11 Apr 2025 (estimated)
- Study completion
- 11 Sep 2025 (estimated)
- First posted
- 25 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
6 secondary outcomes
Proportion of Patients Achieving TICI Score ≥2b After MT
Time frame: Immediately post-procedure
Improvement in NIHSS Score from Baseline to 24 Hours and at Follow-up
Time frame: Baseline, 24 hours, and up to 90 days
Symptomatic Intracerebral Hemorrhage (sICH) Rate
Time frame: Within 7 days post-procedure
All-Cause Mortality at 90 Days
Time frame: 90 days post-procedure
Complication Rate
Time frame: Immediately post-procedure up to 7 days
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ossama yassin MANSOUR, MD, PhD, principal investigator
Alexandria University
farouk Hassan, MD,Phd principal investigator
cairo university, Egypt
Atila Oscan Ozdimar, MD, PhD principal investigator
Eskisehir Osmangazi University
1 site in 1 country: see every site and its status.
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.