SELECT2: A Randomized Controlled Trial to Optimize Patient's Selection for Endovascular Treatment in Acute Ischemic Stroke
SELECT 2 evaluates the efficacy and safety of endovascular thrombectomy compared to medical management alone in acute ischemic stroke patients due to a large vessel occlusion in the distal ICA and MCA M1 who have large core on either CT (ASPECTS: 3-5) or advanced perfusion imaging ([rCBF<30%] on CTP or [ADC<620] on MRI: ≥50cc) or both and are treated within 0-24 hours from last known well.
⁃ Adults (18-85 years) with the final diagnosis of an acute ischemic stroke
⁃ NIH Stroke Scale Score (NIHSS) ≥ 6
⁃ Last known well to groin puncture or medical management between 0 to 24 hours
⁃ Pre-stroke modified Rankin Scale score (mRS) of 0-1
⁃ Eligible for thrombectomy or medical management
⁃ Signed Informed Consent obtained
⁃ Subject willing to comply with the protocol follow-up requirements
⁃ Anticipated life expectancy of at least 3 months
⁃ Specific Neuroimaging Inclusion Criteria:
⁃ Proven large vessel occlusion in ICA or MCA-M1 occlusion (carotid occlusions can be cervical or intracranial, with or without tandem MCA lesions) determined by MRA or CTA
⁃ Large infarct-core lesion on at least one of the following:
• 1. Non-Contrast CT (ASPECTS of 3-5),
• 2. CT perfusion (rCBF<30% ≥50cc),
• 3. MRI-DWI (ADC<620 ≥50cc)