William Mack, Reade Andrew De Leacy, Jonathan A Grossberg, Shahram Majidi, Robert Dana Tomalty, Maxim Mokin, Jan Vargas, Brett L Cucchiara, Kenneth V Snyder, Justin Mascitelli, Victoria Parada, Hakeem J Shakir, David Rosenbaum-Halevi, Amin Aghaebrahim, Daniel Hoit, Benjamin Yim, Matthew S Tenser, Alhamza R Al-Bayati, James M Milburn, Shahid M Nimjee, Neil Haranhalli, Michael Nahhas, Darryn Shaff, Kennith F Layton, Narlin Beaty, Robert M Starke, Harris Hawk, Diogo C Haussen, Aqueel Pabaney, Christopher Paul Kellner, Raul G Nogueira
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引用次数: 0
Abstract
Background: Mechanical thrombectomy is the standard of care for large vessel occlusion (LVO) stroke, yet most device trials focus on individual technologies rather than complete systems.
Objective: To evaluate the safety and efficacy of the Zoom Reperfusion System compared with performance goals derived from a meta-analysis of trials using established thrombectomy technologies.
Methods: Prospective, multicenter, non-randomized, investigational device exemption trial conducted across 26 United States centers from October 2021 to March 2024. Adults with anterior circulation LVO stroke within 8 hours of onset were treated using the Zoom System, which includes aspiration catheters ranging from 0.035″ to 0.071″, and a novel 0.088″ intracranial guide/aspiration catheter. The primary efficacy endpoint was successful reperfusion (modified Thrombolysis in Cerebral Infarction (mTICI) 2b-3) within three passes using Zoom-only components, adjudicated by an independent core laboratory. The primary safety endpoint was symptomatic intracranial hemorrhage (sICH). Secondary outcomes included final reperfusion, first-pass success, time to reperfusion, 90-day modified Rankin Scale (mRS), and mortality.
Results: Among 260 patients (median age 68 years; median National Institutes of Health Stroke Scale (NIHSS) 15), successful reperfusion within three passes was achieved in 83% (216/259; 95% CI: 78% to 89%), exceeding the performance goal (p<0.001). Final reperfusion was 92%, with 5.5% requiring rescue devices. First-pass mTICI 2b-3 success was 57%. Median puncture-to-reperfusion time was 19 min. At 90 days, 55% achieved mRS 0-2. The sICH rate was 1.9%, and 90-day mortality was 12.7%.
Conclusions: The Zoom Reperfusion System demonstrated a safety and efficacy profile exceeding prespecified contemporary performance metrics with potential to significantly shorten reperfusion times and reduce the need for rescue therapy.
期刊介绍：
The Journal of NeuroInterventional Surgery (JNIS) is a leading peer review journal for scientific research and literature pertaining to the field of neurointerventional surgery. The journal launch follows growing professional interest in neurointerventional techniques for the treatment of a range of neurological and vascular problems including stroke, aneurysms, brain tumors, and spinal compression.The journal is owned by SNIS and is also the official journal of the Interventional Chapter of the Australian and New Zealand Society of Neuroradiology (ANZSNR), the Canadian Interventional Neuro Group, the Hong Kong Neurological Society (HKNS) and the Neuroradiological Society of Taiwan.
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