Abstract P486: Mechanical Embolectomy Using a Novel Telescopic System Featuring a Specialized Delivery and 0.088” Aspiration Catheter for the Treatment of Acute Ischemic Stroke: Preliminary Results of the SUMMIT NZ Trial

Abstract

Background: The treatment approach of aspiration rather than use of a stent retriever as first-line therapy is increasingly regarded as standard of care for acute ischemic stroke. Continued technological advances include the ongoing development of aspiration embolectomy catheters that are larger in bore, guided by delivery catheters that are more maneuverable through the tortuous neurovasculature. Methods: SUMMIT NZ (ACTRN12619000890134p) was designed as a prospective, single-arm, open label clinical trial at two sites in New Zealand. Eligible participants were patients presenting with acute ischemic stroke from either anterior or posterior circulation large-vessel occlusion within 24 hours of onset, a National Institutes of Health Stroke Scale Score ≥ 6 and a pre-stroke modified Rankin Score of ≤ 2. A novel tapered tip delivery catheter was specifically designed to deliver 0.070” and 0.088” aspiration catheters telescoped through a specialized 8F 90 cm introducer sheath (Route 92 Medical, Inc. San Mateo, CA). The primary effectiveness endpoint was arterial revascularization as measured by a modified Thrombosis in Cerebrovascular Infarction (mTICI) score of 2b or greater at the end of angiography after all endovascular treatments as adjudicated by an independent core laboratory. The primary safety endpoints were device-related peri-procedural complications such as dissection or perforation, symptomatic Intracranial Cerebral Hemorrhage (SICH) at 24 hours and embolization to a previously uninvolved territory. Results: From September 27, 2019 to June 23, 2020, 18 subjects (mean age 69.5, NIHSSS 15.2, time last known well 6.2 hours) were enrolled with a diagnosis of acute ischemic stroke. Acute occlusion was located in the middle cerebral artery (78%, 14/18) and internal carotid artery (22%, 4/18). Successful revascularization was achieved in 94% (17/18) of subjects. No serious adverse device effects have been reported. Conclusions: Preliminary findings suggest that aspiration first mechanical embolectomy using a novel telescoping system including an 0.088” inner diameter aspiration catheter achieves a high rate of arterial revascularization with an acceptable safety profile. A full report on enrollment and results are to be presented.