Abstract 015: Evaluation of the CEREGLIDE 92 Catheter, a Novel Super‐Bore Aspiration Catheter: SPLENDID Trial Methods

Introduction/Purpose Mechanical thrombectomy (MT) with a direct aspiration first pass technique (ADAPT) has demonstrated similar reperfusion rates and clinical outcomes as MT using stent retrievers. Super bore catheters have larger inner diameters (ID) that are more closely matched to the vessel ID to provide more suction capability when compared to existing large bore aspiration catheters. The purpose of the SPLENDID study is to evaluate the safety and effectiveness of CEREGLIDE 92 Catheter (largest 8F catheter designed for intracranial access) in the treatment of patients with acute ischemic stroke (AIS) due to large vessel occlusion (LVO) within the internal carotid, middle cerebral‐M1 segment, basilar, and vertebral arteries up to 24hrs. Methods SPLENDID is a prospective, multicenter, single arm, IDE trial that will enroll up to 140 subjects at up to 25 sites. CEREGLIDE 92 will be used for direct aspiration as the first attempted MT device/technique. Follow‐up will occur at 24 hours, 7 days (or discharge), and 90 days post‐procedure. An Imaging Core Lab, blinded independent evaluation of 90‐day modified Rankin Scale (mRS), Clinical Events Committee (CEC) and Data Monitoring Committee (DMC) will be used. Results The primary effectiveness endpoint will be first pass reperfusion (eTICI≥2b50 without additional therapy) per the Imaging Core Lab. Secondary effectiveness endpoints will be 90‐day mRS 0‐2, time to reperfusion, first pass reperfusion (eTICI≥2c without additional therapy), final procedural reperfusion (eTICI≥2c), final procedural reperfusion (eTICI 3), and embolization in new territory. Secondary safety endpoints will include 90‐day all‐cause mortality, 24‐hour symptomatic intracranial hemorrhage per CEC, and serious adverse device effects through 30 days per CEC. Health value endpoints will include hospitalization length of stay, healthcare resource utilization, and 90‐day patient‐reported Quality of Life using the PROMIS‐10. Conclusion SPLENDID will prospectively evaluate the clinical impact of super large bore aspiration using the CEREGLIDE 92 Catheter for direct aspiration as the first attempted MT technique and is the first IDE (investigational device exemption) study to use first‐pass effect as the primary endpoint.