Dabus Guilherme, Puri Ajit S, McGuinness Ben, Priest Ryan A, Rai Ansaar T, Gross Bradley A, Zaidat Osama O, Hanel Ricardo A, Shazam Hussain M, Shaikh Hamza A, English Joey D, Nguyen Thanh N
Miami Neuroscience Institute and Miami Cardiac & Vascular Institute, Baptist Health South Florida, Miami, FL, USA.
University of Massachusetts, Worcester, MA, USA.
Interv Neuroradiol. 2024 Sep 9:15910199241270711. doi: 10.1177/15910199241270711.
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.
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.
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).
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.
与单纯药物治疗相比，采用机械取栓联合或不联合静脉溶栓治疗大血管闭塞（LVO）已显示出更好的疗效。大口径抽吸导管最近已被引入。其有效性和安全性尚未在随机试验中得到证实。SUMMIT MAX研究旨在解决这一问题。
SUMMIT MAX是一项随机对照试验，将大口径单点再灌注系统（Route 92 Medical，加利福尼亚州圣马特奥）的有效性和安全性与目前美国食品药品监督管理局（FDA）批准的最大的抽吸取栓装置AXS Vecta抽吸系统（Stryker Neurovascular，加利福尼亚州弗里蒙特）进行比较。该研究是一项多中心、前瞻性、随机、对照、干预性、开放标签的临床试验。假设是通过再通率（改良的脑血管梗死溶栓 - mTICI）衡量的医疗单点再灌注系统的有效性以及通过症状性颅内出血率（sICH）衡量的安全性不劣于AXS Vecta抽吸系统。
招募了多达250名受试者，其中至少50%的受试者由美国的研究点招募。主要有效性终点是成功的动脉血管再通，定义为在使用指定装置后由独立核心实验室判定的mTICI评分≥2b。主要安全性终点定义为术后24小时内（-8/+24）发生的sICH。次要终点包括在使用指定装置联合或不联合辅助治疗后定义为mTICI评分≥2b的成功动脉血管再通；与装置相关的严重不良事件；所有无症状出血；从腹股沟穿刺到最终血管造影的时间；以及首次通过效应率，定义为使用指定装置首次通过后mTICI 2b，并按年龄分层（≤85岁，≥86岁）。
SUMMIT MAX是一项随机对照试验，比较了一种新型大口径抽吸装置与目前FDA批准的最大抽吸装置的有效性和安全性。
