Emergent Large Vessel Occlusion Endovascular Rescue Therapy With Underlying Intracranial Stenosis
The study objective is to establish the safety and efficacy of endovascular adjunct stenting for patients undergoing mechanical thrombectomy (MT) that are found to have residual stenosis (70-99%) following attempted clot retrieval with either aspiration catheters or stent retrievers, per device instructions for use and device labeling.
• 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