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.

IF 1.7 4区 医学 Q3 Medicine Interventional Neuroradiology Pub Date : 2024-09-09 DOI:10.1177/15910199241270711
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
{"title":"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.","authors":"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","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":14380,"journal":{"name":"Interventional Neuroradiology","volume":" ","pages":"15910199241270711"},"PeriodicalIF":1.7000,"publicationDate":"2024-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Interventional Neuroradiology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/15910199241270711","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"Medicine","Score":null,"Total":0}
引用次数: 0

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.

查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
一项前瞻性、随机对照、介入性临床试验,旨在评估用于急性缺血性脑卒中患者抽吸血栓切除术的医用单点再灌注系统(SUMMIT MAX)的安全性和有效性:试验原理与设计。
背景:与单纯药物治疗相比,使用机械血栓切除术结合或不结合静脉溶栓治疗大血管闭塞(LVO)的疗效更好。最近推出了大口径抽吸导管。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,将把大口径 Monopoint Reperfusion 系统(Route 92 Medical,加利福尼亚州圣马特奥市)的有效性和安全性与目前最大的经 FDA 批准的抽吸血栓切除设备 AXS Vecta 抽吸系统(Stryker Neurovascular,加利福尼亚州弗里蒙特市)进行比较。该研究是一项多中心、前瞻性、随机对照、介入性、开放标签临床试验。研究假设:以再通率(改良的脑血管梗塞溶栓治疗--mTICI)衡量的医用单点再灌注系统的有效性和以症状性颅内出血率(sICH)衡量的安全性均不劣于 AXS Vecta 抽吸系统:结果:多达250名受试者被纳入研究,其中至少50%的受试者由美国研究机构纳入。主要有效性终点是成功的动脉血管再通,定义为使用指定设备后由独立核心实验室裁定的 mTICI 评分≥2b。主要安全性终点定义为术后 24 小时(-8/+24)内的 sICH。次要终点包括:成功的动脉血管再通,即在使用或不使用辅助疗法的情况下,使用指定器械后 mTICI 评分≥2b;与器械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;首次通过效果率,即使用指定器械首次通过后 mTICI 评分≥2b,按年龄分层(≤85,≥86):SUMMIT MAX 是一项随机对照试验,比较了新型大口径抽吸器械与目前美国食品药品管理局批准的最大抽吸器械的有效性和安全性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 去求助
来源期刊
CiteScore
2.80
自引率
11.80%
发文量
192
审稿时长
6-12 weeks
期刊介绍: Interventional Neuroradiology (INR) is a peer-reviewed clinical practice journal documenting the current state of interventional neuroradiology worldwide. INR publishes original clinical observations, descriptions of new techniques or procedures, case reports, and articles on the ethical and social aspects of related health care. Original research published in INR is related to the practice of interventional neuroradiology...
期刊最新文献
Balloon angioplasty for cerebral vasospasm in preschool children. Transradial versus transfemoral access for mechanical thrombectomy: A single institution experience. Validity of Woven EndoBridge sizing based on the device-to-aneurysm volume ratio. Accelerated aspiration with Q™ catheter: An in vitro study. High mechanical thrombectomy procedural volume is not a reliable predictor of improved thrombectomy outcomes in patients with acute ischemic stroke in the United States.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1