Clinical trial NCT06702787: Mechanical Thrombectomy in the Middle East and North Africa: Interim Results from the MEMENTO Registry
Official title: Mechanical Thrombectomy in the Middle East and North Africa: Interim Results from the MEMENTO Registry
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
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
Lead sponsor: Middle East North Africa Stroke and Interventional Neurotherapies Organization
Sponsor class: OTHER
First posted: 2024-11-25
Enrollment: 1500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Functional Independence at 90 Days
timeFrame: 90 days post-procedure
Secondary outcomes:
measure: Proportion of Patients Achieving TICI Score ≥2b After MT
timeFrame: Immediately post-procedure
measure: Improvement in NIHSS Score from Baseline to 24 Hours and at Follow-up
timeFrame: Baseline, 24 hours, and up to 90 days
measure: Symptomatic Intracerebral Hemorrhage (sICH) Rate
timeFrame: Within 7 days post-procedure
measure: All-Cause Mortality at 90 Days
timeFrame: 90 days post-procedure
measure: Complication Rate
timeFrame: Immediately post-procedure up to 7 days
measure: Incremental Cost-Effectiveness Ratio (ICER) per Quality-Adjusted Life Year (QALY) Gained
timeFrame: From baseline (pre-procedure) through 90 days post-procedure, with economic modeling extended to a lifetime horizon (up to 20 years)
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria University Stroke network
Study officials:
affiliation: Alexandria University
name: ossama yassin MANSOUR, MD, PhD,
role: PRINCIPAL_INVESTIGATOR
affiliation: cairo university, Egypt
name: farouk Hassan, MD,Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Eskisehir Osmangazi University
name: Atila Oscan Ozdimar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cleveland Clinic Abu Dhabi
name: Syed Irteza Hussain, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: King Abdullah Medical City
name: Faisal Alghamdi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: institut National de Neurologie
name: Nadia Hammami, MD
role: PRINCIPAL_INVESTIGATOR
References: