Abstract 001: Aspiration with super‐large bore 0.088 ID catheters in patients with acute ischemic stroke: The final results of an FDA‐approved trial

• Published in: Stroke: vascular and interventional neurology Vol. 4; no. S1
• Main Authors: Mokin, M, Grossberg, J A, Tomalty, D, Majidi, S, Vargas, J, Cucchiara, B L, Snyder, K V, Mascitelli, J R, Parada, V, Shakir, H J, Rosenbaum-Halevi, D, Aghaebrahim, N, Hoit, D, Yim, B, Tenser, M S, Al-Bayati, A R, Milburn, J M, Singer, J A, Nimjee, S M, Haranhalli, N, Sheth, S A, Shaff, D I, Layton, K F, Beaty, N B, Starke, R M, Hawk, H, Haussen, D C, Pabaney, A, Kellner, C P, De Leacy, R A, Nogueira, R G, Mack, W J
• Format: Journal Article
• Language: English
• Published: Phoenix Wiley Subscription Services, Inc 01.11.2024
• Subjects: Catheters; FDA approval; Ischemia; Mortality
• ISSN: 2694-5746; 2694-5746
• DOI: 10.1161/SVIN.04.suppl_1.001

IntroductionAspiration thrombectomy is a well‐established treatment for patients with acute ischemic stroke (AIS) due to large vessel occlusion (LVO). However, the safety and efficacy of aspiration using super‐large bore catheters (0.088” ID) have not been well studied.MethodsWe conducted an FDA‐approved Investigational Device Exemption study across 26 institutions in the United States to evaluate the clinical performance of the Zoom Reperfusion System, including the use of 0.088” ID super‐large bore aspiration catheters (Imperative Care, Inc., Campbell, California). Patients who met the study's inclusion and exclusion criteria were prospectively consented and treated between October 2021 and March 2024. Analysis was prespecified to be performed on the modified intent‐to‐treat population. The primary efficacy endpoint was achieving core lab adjudicated mTICI ≥2b, using the primary treatment modality (Zoom System only) within ≤3 passes, without additional therapies. The primary safety endpoint, adjudicated by the core lab and an Independent Safety Board (ISB), was the rate of symptomatic intracranial hemorrhage (sICH), per the ECASS III definition. The secondary safety endpoint was all‐cause mortality at 90 days. Performance goals were established in collaboration with the FDA. Covariate analyses were conducted to evaluate reperfusion success when aspiration with the 0.088” ID catheters was performed intracranially vs extracranially and at the clot versus not at the clot. Pre‐specified FDA analyses were performed by an independent statistician.ResultsThe modified intent‐to‐treat population includes 260 evaluable subjects. Core lab adjudicated successful reperfusion (mTICI ≥2b) within ≤3 passes without alternative devices was 83% (216/259), 95% CI 78%‐88%. After all passes with the Zoom system, successful reperfusion was 86% (224/259), 95% CI 82%‐90%. Successful reperfusion at the end of the procedure was 92% (238/259), 95% CI 88%‐95%. Core lab and ISB adjudicated sICH rate was 1.9% (5/260), 95% CI 0.6%‐4.4%. 90‐day all‐cause mortality was 12.7% (33/260); when imputing the worst‐case scenario for seven patients with unknown living status mortality was potentially 15.4% (40/260). Median time from groin puncture to mTICI ≥2b, mTICI ≥2c and procedure completion was 19 minutes (IQR 13‐30), 21 minutes (IQR 14‐35) and 23 minutes (IQR 15‐40), respectively. Numerically higher rates of reperfusion success after all Zoom passes were observed with intracranial 0.088” ID aspiration (87% vs. 83% extracranial) and 0.088” ID aspiration at the clot (90% vs. 83% not at clot).ConclusionThese data suggest the Zoom Reperfusion System, including 0.088” ID aspiration, is safe and effective in achieving reperfusion in patients with AIS due to LVO. All three pre‐specified performance goals were met. Performing more distal 0.088” aspiration may improve reperfusion rates.