A prospective, randomized, controlled, interventional clinical trial to evaluate the safety and efficacy of the medical monopoint reperfusion system for aspiration thrombectomy in acute ischemic stroke patients (SUMMIT MAX): Trial rationale and design

Guilherme Dabus; Ajit S Puri; Ben McGuinness; Ryan A Priest; Ansaar T Rai; Bradley A Gross; Osama O Zaidat; Ricardo A Hanel; M Shazam Hussain; Hamza A Shaikh; Joey D English; Thanh N Nguyen

doi:10.1177/15910199241270711

A prospective, randomized, controlled, interventional clinical trial to evaluate the safety and efficacy of the medical monopoint reperfusion system for aspiration thrombectomy in acute ischemic stroke patients (SUMMIT MAX): Trial rationale and design

Interv Neuroradiol. 2024 Sep 9:15910199241270711. doi: 10.1177/15910199241270711. Online ahead of print.

Authors

Affiliations

¹ Miami Neuroscience Institute and Miami Cardiac & Vascular Institute, Baptist Health South Florida, Miami, FL, USA.
² University of Massachusetts, Worcester, MA, USA.
³ Auckland City Hospital, Auckland, New Zealand.
⁴ Dotter Interventional Institute, Oregon Health & Science University, Portland, OR, USA.
⁵ Rockefeller Neuroscience Institute, West Virginia University, Morgantown, WV, USA.
⁶ University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
⁷ Mercy St Vicent Medical Center, Toledo, OH, USA.
⁸ Baptist Medical Center, Jacksonville, FL, USA.
⁹ Cleveland Clinic, Cleveland, OH, USA.
¹⁰ Cooper University, Camden, NJ, USA.
¹¹ Sutter Health, San Francisco, CA, USA.
¹² Boston Medical Center, Boston University Chobanian and Avedisian School of Medicine, Boston, MA, USA.

Abstract

Background: Treatment of large vessel occlusion (LVO) using mechanical thrombectomy with or without intravenous thrombolysis has demonstrated better outcomes compared to medical treatment alone. Large-bore aspiration catheters have been recently introduced. Their effectiveness and safety have not been demonstrated in a randomized trial. The SUMMIT MAX study is designed to address this question.

Methods: SUMMIT MAX is a randomized controlled trial where the effectiveness and safety of the large-bore Monopoint Reperfusion system (Route 92 Medical, San Mateo, CA), will be compared to the currently largest available FDA-cleared aspiration thrombectomy device the AXS Vecta Aspiration system (Stryker Neurovascular, Fremont, CA). The study is a multi-center, prospective, randomized, controlled, interventional, open label clinical trial. The hypothesis is that the effectiveness measured by the recanalization rate (modified thrombolysis in cerebrovascular infarction - mTICI) and safety measured by symptomatic intracranial hemorrhage rate (sICH) of the medical monopoint reperfusion system is non-inferior to the AXS Vecta Aspiration system.

Results: Up to 250 subjects are enrolled with at least 50% of subjects enrolled by US sites. The primary effectiveness endpoint is successful arterial revascularization defined as an mTICI score ≥ 2b after use of the assigned device adjudicated by an independent core lab. The primary safety endpoint is defined as sICH within 24 h (-8/+24) post-procedure. Secondary endpoints include successful arterial revascularization defined as a mTICI score ≥ 2b after use of the assigned device with or without adjunctive therapy; device-related serious adverse events; all asymptomatic hemorrhages; time from groin puncture to final angiogram; and rate of first pass effect defined as mTICI 2b after first pass with the assigned device stratified by age (≤85, ≥ 86).

Conclusion: SUMMIT MAX is a randomized controlled trial comparing the effectiveness and safety of a new large bore class of aspiration devices to the currently largest FDA-cleared aspiration device available.

Keywords: Stroke; aspiration catheter; endovascular therapy; randomized trial; thrombectomy; trial protocol.