SUMMIT MAX: A Randomized Trial of the Super Large Bore HiPoint Reperfusion System Versus Vecta System for Aspiration Thrombectomy

作者：Thanh N. Nguyen, Guilherme Dabus, Ben McGuinness, J. Caldwell, Ryan Priest, Ansaar Rai, Osama O. Zaidat, Bradley A. Gross, Ricardó A. Hanel, Shane S Lee, Muhammad Shazam Hussain, Hamza Shaikh, Mohamad Abdalkader, Ronald F. Budzik, Craig Kilburg, Keith Woodward, Marco Colasurdo, Jesse Liu, Albert J. Yoo, Priyank Khandelwal, SoHyun Boo, Phong Vu, Eugene Lin, Mohammad Almajali, Jasmeet Singh, Alhamza R Al‐Bayati, Michael J. Lang, Michael Abraham, Ameer E Hassan, Peter Pema, Coleman Martin, Ramesh Grandhi, Daniel A. Tonetti, H Hixson, Amin Aghaebrahim, Eric Sauvageau, Santiago Ortega‐Gutiérrez, Dileep R. Yavagal, Esteban Cheng‐Ching, Jane Khalife, Italo Linfante, Volodymyr Vulkanov, Jazba Soomro, Johanna T Fifi, Lucien Maidan, Alexander Copelan, Clemens M. Schirmer, Mark Bain, Gábor Tóth, Mahesh Jayaraman, Roberta Novakovic‐White, Sudhakar R Satti, Nicolas W. Villelli, Pascal Jabbour, Matthew P. Page, Davina McAllister, Robert Araujo‐Contreras, Edgar A. Samaniego, David S. Liebeskind, Steven W. Hetts, Raul G. Nogueira, Joey English, Ajit S. Puri · 发表于：Stroke · 年份：2025 · DOI：10.1161/strokeaha.125.051742 · 被引用次数：23 · 研究领域：Acute Ischemic Stroke Management、Cerebrovascular and Carotid Artery Diseases、Intracranial Aneurysms: Treatment and Complications

BACKGROUND: Rapid and complete recanalization is a primary goal in the endovascular treatment of large vessel occlusion stroke. The effectiveness and safety of super large bore aspiration catheters (0.088″ inner diameter) for the treatment of large vessel occlusion stroke have not been demonstrated in a randomized trial. METHODS: SUMMIT MAX (A Prospective, Randomized, Controlled, Interventional Clinical Trial to Evaluate the Safety and Effectiveness of the Route 92 Medical MonoPoint Reperfusion System for Aspiration Embolectomy in Acute Ischemic Stroke Patients) was a prospective, randomized, controlled, open-label clinical trial of patients with internal carotid artery and middle cerebral artery M1 occlusions, comparing the super large bore HiPoint Reperfusion system (Route 92 Medical) to the Vecta Aspiration system (Stryker Neurovascular). We hypothesized that the effectiveness and safety of the HiPoint reperfusion system were noninferior (12.5% noninferiority margin) to the Vecta Aspiration system. The primary effectiveness end point was successful reperfusion, defined as modified Treatment in Cerebral Infarction≥2b as adjudicated by an independent core lab, using only the assigned study device, with any use of a nonstudy device before or after the use of study device defined as failure. The primary safety end point was symptomatic intracranial hemorrhage within 24 hours (−8/+24) post-procedure. RESULTS: There were 250 patients enrolled of whom 166 met the criteria for the...