Table 1.
Eligibility Criteria
Inclusion Criteria | Exclusion Criteria |
---|---|
New focal disabling neurologic deficit consistent with acute cerebral ischemia (NIHSS ≥ 6 with at least six points attributed to current stroke) | NIHSS ≥ 30 |
Age ≥ 18 ≤ 85 | Acute intracranial hemorrhage |
Clot retrieval procedure can be initiated within 8 hours from onset | Coma |
Large vessel proximal anterior circulation occlusion on MR or CT angiography (internal carotid, M1 or M2 MCA) | Rapidly improving neurological signs prior to randomization |
Signed informed consent obtained from the patient or patient’s legally authorized representative (or via waiver of consent if IRB/FDA approved for enrollment under waiver) | Pre-existing medical, neurological or psychiatric disease that would confound the neurological, functional, or imaging evaluations |
Pretreatment multimodal MRI or CT performed according to MR RESCUE protocol | Pregnancy |
Premorbid modified Rankin score of 0–2 | Known allergy to iodine previously refractory to pretreatment medications |
Allowed but not required: patients treated with IV tPA up to 4.5 hours from symptom onset with persistent target occlusion on post-treatment MR RESCUE MR or CT protocol performed at the completion of drug infusion | Current participation in another experimental treatment protocol |
Contrast-Enhanced Neck MRA or CTA suggests proximal ICA occlusion, proximal carotid stenosis > 67%, or dissection | |
INR > 3.0 | |
PTT > 3 × Normal | |
Imaging data cannot be processed by MR RESCUE computer | |
Renal failure: serum creatinine > 2.0 or GFR < 30 | |
MRI*: contraindication to MRI | |
CT*: contraindication to iodinated contrast |
Baseline imaging modality