SELECT2: A Randomized Controlled Trial to Optimize Patient's Selection for Endovascular Treatment in Acute Ischemic Stroke

Prior treatment

• Treatment with thrombolytic agent beyond 4.5 hours from last known well
• Treated with thrombolytic agent 3-4.5 hours after last known well AND any of the following:
  • 1\) age \>80,
  • 2\) current anticoagulant use,
  • 3\) history of diabetes AND prior stroke,
  • 4\) NIHSS \>25,
  • 5\) ischemic involvement of \> 1/3 MCA territory
• Current participation in another investigational drug or device study.
  • Neuroimaging Exclusion Criteria

Other illness

• Inability to undergo CT angiography and/or CT perfusion imaging (e.g., renal insufficiency, iodine/contrast allergy)
• Co-morbid psychiatric or medical illnesses that would confound the neurological assessments
• Evidence of intracranial tumor (except small meningioma), acute intracranial hemorrhage, neoplasm, or arteriovenous malformation

Other

• Patients who have both ASPECTS of 6-10 on non-contrast CT AND core volume \<50 cc on perfusion imaging
• Patients with very large core on non-contrast CT i.e. ASPECTS ≤ 2
• A significant mass effect with midline shift
• Evidence of internal carotid artery dissection that is flow limiting or aortic dissection
• Intracranial stent implanted in the same vascular territory that precludes the safe deployment/removal of the neurothrombectomy device
• Acute symptomatic arterial occlusions in more than one vascular territory confirmed on CTA/MRA (e.g., bilateral MCA occlusions, or an MCA and a basilar artery occlusion).
• Signs of established infarct and large area of cerebral edema on non-contrast CT

• 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:
  • 2.1. Non-Contrast CT (ASPECTS of 3-5),
  • 2.2. CT perfusion (rCBF\<30% ≥50cc),
  • 2.3. MRI-DWI (ADC\<620 ≥50cc)