Albert J Yoo, Serdar Geyik, Michael T Froehler, Christoph Johannes Maurer, Tareq Kass-Hout, Osama O Zaidat, Raul G Nogueira, Ricardo A Hanel, Laurent Pierot, Laurent Spelle, Demetrius Lopes, Ameer Hassan, Audrius Širvinskas, Eugene Lin, Marc Ribo, Jordi Blasco, Muhammad Asif Taqi, Aamir Badruddin, Adnan H Siddiqui, Timothy R Miller, Shazam M Hussain, Diogo C Haussen, Keith Woodward, Christoph Groden, Arturo Consoli, M Imran Chaudry, Christian Ramsey, Alberto Maud, Joshua Bentley, Arsida Bajrami, Maher Sahnoun, Jens Fiehler, Rishi Gupta
{"title":"Primary results from the CLEAR study of a novel stent retriever with drop zone technology.","authors":"Albert J Yoo, Serdar Geyik, Michael T Froehler, Christoph Johannes Maurer, Tareq Kass-Hout, Osama O Zaidat, Raul G Nogueira, Ricardo A Hanel, Laurent Pierot, Laurent Spelle, Demetrius Lopes, Ameer Hassan, Audrius Širvinskas, Eugene Lin, Marc Ribo, Jordi Blasco, Muhammad Asif Taqi, Aamir Badruddin, Adnan H Siddiqui, Timothy R Miller, Shazam M Hussain, Diogo C Haussen, Keith Woodward, Christoph Groden, Arturo Consoli, M Imran Chaudry, Christian Ramsey, Alberto Maud, Joshua Bentley, Arsida Bajrami, Maher Sahnoun, Jens Fiehler, Rishi Gupta","doi":"10.1136/jnis-2023-020960","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Challenges to revascularization of large vessel occlusions (LVOs) persist. Current stent retrievers have limited effectiveness for removing organized thrombi. The NeVa device is a novel stent retriever designed to capture organized thrombi within the scaffold during retrieval.</p><p><strong>Objective: </strong>To evaluate the safety and effectiveness of revascularization of acute LVOs with the NeVa device.</p><p><strong>Methods: </strong>Prospective, international, multicenter, single-arm, Investigational Device Exemption study to evaluate the performance of the NeVa device in recanalizing LVOs including internal carotid artery, M1/M2 middle cerebral artery, and vertebrobasilar arteries, within 8 hours of onset. Primary endpoint was rate of expanded Treatment in Cerebral Ischemia (eTICI) score 2b-3 within 3 NeVa passes, tested for non-inferiority against a performance goal of 72% with a -10% margin. Additional endpoints included first pass success and 90-day modified Rankin Scale (mRS) score 0-2. Primary composite safety endpoint was 90-day mortality and/or 24-hour symptomatic intracranial hemorrhage (sICH).</p><p><strong>Results: </strong>From April 2021 to April 2022, 139 subjects were enrolled at 25 centers. Median National Institutes of Health Stroke Scale (NIHSS) score was 16 (IQR 12-20). In the primary analysis population (n=107), eTICI 2b-3 within 3 NeVa passes occurred in 90.7% (97/107; non-inferiority P<0.0001; post hoc superiority P<0.0001). First pass eTICI 2b-3 was observed in 73.8% (79/107), with first pass eTICI 2b67-3 in 69.2% (74/107) and eTICI 2c-3 in 48.6% (52/107). Median number of passes was 1 (IQR 1-2). Final eTICI 2b-3 rate was 99.1% (106/107); final eTICI 2b67-3 rate was 91.6% (98/107); final eTICI 2c-3 rate was 72.9% (78/107). Good outcome (90-day mRS score 0-2) was seen in 65.1% (69/106). Mortality was 9.4% (13/138) with sICH in 5.0% (7/139).</p><p><strong>Conclusions: </strong>The NeVa device is highly effective and safe for revascularization of LVO strokes and demonstrates superior first pass success compared with a predicate performance goal.</p><p><strong>Trial registration number: </strong>NCT04514562.</p>","PeriodicalId":16411,"journal":{"name":"Journal of NeuroInterventional Surgery","volume":" ","pages":"1220-1227"},"PeriodicalIF":4.5000,"publicationDate":"2024-11-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of NeuroInterventional Surgery","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1136/jnis-2023-020960","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"NEUROIMAGING","Score":null,"Total":0}
引用次数: 0
Abstract
Background: Challenges to revascularization of large vessel occlusions (LVOs) persist. Current stent retrievers have limited effectiveness for removing organized thrombi. The NeVa device is a novel stent retriever designed to capture organized thrombi within the scaffold during retrieval.
Objective: To evaluate the safety and effectiveness of revascularization of acute LVOs with the NeVa device.
Methods: Prospective, international, multicenter, single-arm, Investigational Device Exemption study to evaluate the performance of the NeVa device in recanalizing LVOs including internal carotid artery, M1/M2 middle cerebral artery, and vertebrobasilar arteries, within 8 hours of onset. Primary endpoint was rate of expanded Treatment in Cerebral Ischemia (eTICI) score 2b-3 within 3 NeVa passes, tested for non-inferiority against a performance goal of 72% with a -10% margin. Additional endpoints included first pass success and 90-day modified Rankin Scale (mRS) score 0-2. Primary composite safety endpoint was 90-day mortality and/or 24-hour symptomatic intracranial hemorrhage (sICH).
Results: From April 2021 to April 2022, 139 subjects were enrolled at 25 centers. Median National Institutes of Health Stroke Scale (NIHSS) score was 16 (IQR 12-20). In the primary analysis population (n=107), eTICI 2b-3 within 3 NeVa passes occurred in 90.7% (97/107; non-inferiority P<0.0001; post hoc superiority P<0.0001). First pass eTICI 2b-3 was observed in 73.8% (79/107), with first pass eTICI 2b67-3 in 69.2% (74/107) and eTICI 2c-3 in 48.6% (52/107). Median number of passes was 1 (IQR 1-2). Final eTICI 2b-3 rate was 99.1% (106/107); final eTICI 2b67-3 rate was 91.6% (98/107); final eTICI 2c-3 rate was 72.9% (78/107). Good outcome (90-day mRS score 0-2) was seen in 65.1% (69/106). Mortality was 9.4% (13/138) with sICH in 5.0% (7/139).
Conclusions: The NeVa device is highly effective and safe for revascularization of LVO strokes and demonstrates superior first pass success compared with a predicate performance goal.
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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