Proximal Internal Carotid Artery Acute Stroke Secondary to Tandem or Local Occlusion Thrombectomy Trial
The primary objective is to establish the efficacy of intra-arterial (IA) mechanical thrombectomy (MT) with extracranial proximal carotid artery acute stenting versus non-stenting approaches in patients with acute ischemic stroke (AIS) from intracranial vessel occlusion (IVO) in the anterior circulation and have a proximal carotid occlusive disease (occlusion or severe stenosis).
• 18 to 79 years of age (before the 80th birthday)
• Presenting with symptoms consistent with AIS
• Imaging evidence of an anterior circulation occlusion of the Internal Carotid Artery (ICA) terminus and/or Middle Cerebral Artery Main Stem (MCA M1), or proximal M2 segment AND extra-cranial proximal carotid occlusion / severe stenosis related to atherosclerosis requiring treatment on non-invasive imaging ≥70%
• NIHSS ≥ 4
• Ability to randomize and start endovascular therapy within 16 hours of stroke onset
• Pre-stroke mRS score 0-2
• Ability to obtain signed informed consent
• ASPECTS Score ≥7 via non-contrast CT or MRI (DWI) for subjects ≤6 hours from stroke onset OR ASPECTS Score ≥7 + infarct core volume \<50 cc quantified by CTP (rCBF\<30%) OR \<25 cc quantified by MRI-DWI (AxBxC/2) for subjects with endovascular therapy starting between \>6h to 16 hours from stroke onset, given the need for antiplatelet therapy.
• Acute Neurological Deficit with Imaging evidence of Tandem Lesion:
• Extracranial carotid occlusion (70% to 100% Using NACET criteria) With or without intracranial vascular occlusion
⁃ Must be ineligible for IV t-PA therapy or have failed IV t-PA therapy