The MAPS 2 (Multicenter Acute Stroke Interventional Study 2) trial is a clinical trial aimed at evaluating the efficacy and safety of endovascular thrombectomy (EVT) as a treatment for acute ischemic stroke (AIS). EVT is a minimally invasive procedure that involves the removal of a blood clot from an obstructed blood vessel in the brain using a catheter-based approach. The trial is designed to select eligible participants based on specific criteria that ensure the safety and efficacy of the intervention. In this answer, we will discuss the criteria for selecting participants in the MAPS 2 trial.
To be eligible for enrollment in the MAPS 2 trial, participants must meet the following inclusion criteria:
Age: Participants must be 18 years or older.
Diagnosis: Participants must have a confirmed diagnosis of acute ischemic stroke with a National Institutes of Health Stroke Scale (NIHSS) score of 6 or higher.
Time of onset: Participants must present within 6 hours of stroke onset. This means that the onset of symptoms must have occurred less than 6 hours before the participant presents at the hospital.
Occlusion location: Participants must have occlusion of the internal carotid artery or middle cerebral artery (M1 or M2 segment).
Imaging criteria: Participants must have imaging evidence of a large vessel occlusion (LVO) on computed tomography angiography (CTA) or magnetic resonance angiography (MRA). The occlusion must be in a vessel that supplies a significant portion of the brain tissue.
Consent: Participants or their legal representatives must provide informed consent for participation in the trial.
The following criteria are used to exclude participants from enrollment in the MAPS 2 trial:
Time of onset: Participants presenting more than 6 hours after stroke onset are excluded.
Pre-existing disability: Participants with a pre-existing modified Rankin Scale (mRS) score of 2 or higher are excluded. The mRS is a scale that measures the degree of disability or dependence in daily activities.
Contraindications for EVT: Participants with contraindications for EVT, such as bleeding disorders or recent surgery, are excluded.
Other medical conditions: Participants with other medical conditions that may affect the outcome of the trial, such as severe liver or kidney disease, are excluded.
Other stroke subtypes: Participants with stroke caused by other etiologies, such as hemorrhagic stroke or subarachnoid hemorrhage, are excluded.
Pregnancy: Pregnant women are excluded from the trial due to the potential risks associated with EVT.
Participation in other trials: Participants currently participating in other interventional trials or who have participated in interventional trials within the past 30 days are excluded.
The selection of participants in the MAPS 2 trial is based on strict criteria aimed at ensuring the safety and efficacy of the EVT intervention. These criteria include age, diagnosis, time of onset, occlusion location, imaging criteria, and consent. Exclusion criteria are also used to exclude participants with pre-existing disabilities, contraindications for EVT, other medical conditions, pregnancy, and participation in other trials. The criteria used for participant selection in the MAPS 2 trial are essential for ensuring the reliability of the study results and the safety of the participants.