Emergent Large Vessel Occlusion Endovascular Rescue Therapy With Underlying Intracranial Stenosis

Prior treatment

• Intracranial tumors other than small meningioma, that do not require surgery for at least one year post randomization. Small meningioma is defined as a lesion measuring ≤20mm in maximum diameter or ≤4cm3 in volume, with no associated mass effect, peritumoral edema, or progressive neurological symptoms
• Life expectancy less than one year prior to stroke onset

Other illness

• Known severe allergy (more than a rash) to contrast media uncontrolled by medications.
• CT evidence of the following conditions:
  • Midline shift or herniation
  • Evidence of intracranial hemorrhage
  • Mass effect with effacement of the ventricles
• Any other condition (in the opinion of the site investigator) that precludes an endovascular procedure or poses a significant hazard to the patient if an endovascular procedure was performed
• New diagnosis of atrial fibrillation or a history of atrial fibrillation

Lab values

• Females who are pregnant, or those of child-bearing potential with positive urine or serum beta Human Chorionic Gonadotropin (HCG) test
• Known hemorrhagic diathesis, coagulation factor deficiency, or on anticoagulant therapy with an International Normalized Ratio (INR) of \>3.0 or Partial Thromboplastin Time (PTT) \>3 times of normal
• Baseline platelet count \<80,000 per microliter (µl)

Other

• Acute bilateral strokes
• Contraindication to antiplatelet (aspirin, clopidogrel, ticagrelor, cangrelor) or contrast agents
• Participation in another randomized clinical trial that could confound the evaluation of the study outcomes.
• Suspected device-induced vasospasm defined as smooth transient narrowing of the target vessel
• Vessel dissection including any of the following: presence of dissection flap, false lumen, contrast stagnation in the vessel wall, and/or improving stenosis
  • \-

• 18 to 80 years of age
• Presenting with symptoms consistent with AIS
• Imaging evidence of an anterior occlusion of the Internal Carotid Artery (ICA) or Middle Cerebral Artery Main Stem (MCA M1), or proximal M2 segment AND residual 70-99% stenosis of the index artery following attempted clot retrieval with either aspiration catheters or stent retrievers, per device instructions for use and device labeling
• NIHSS ≥ 6
• Ability to randomize within 24 hours of stroke onset.
• Pre-stroke mRS score 0-2
• Ability to obtain signed informed consent.
• ASPECTS Score ≥ 6 by non-contrast CT scan
• Score-ICAD score of ≥11 points at screening and/or persistent stenotic occlusion of ≥70% after MT
• If indicated, thrombolytic therapy shall be initiated per the institution's usual care and the most recent version of the AHA/ASA Guidelines. Subjects eligible for IV thrombolysis should receive it without delay.
• For subjects presenting \>6 hours from stroke onset, infarct core volume \<50 cc quantified by CTP