EnDovascular Therapy Plus Best Medical Treatment (BMT) Versus BMT Alone for MedIum distal VeSsel Occlusion sTroke (DISTAL)
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Publication Date: | 2024 |
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Format: | Article |
Language: | eng |
Source: | Repositórios Científicos de Acesso Aberto de Portugal (RCAAP) |
Download full: | http://hdl.handle.net/10362/167821 |
Summary: | Funding Information: The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The trial is supported by public grants from the Swiss National Science Foundation (SNSF grant number 33IC30_198783) and the Gottfried und Julia Bangerter-Rhyner-Stiftung (Basel, Switzerland) as well as through unrestricted grants from Stryker Neurovascular Inc., Medtronic Inc., Phenox GmbH, Rapid Medical Inc., and Penumbra Inc.. The funders had no role in the design, site selection, planning or conduct of the trial and they will have no role in the analysis of the trial data, the writing of the manuscript or the interpretation of the trial data. Funding Information: Jens Fiehler: Research support: German Ministry of Science and Education (BMBF), German Ministry of Economy and Innovation (BMWi), German Research Foundation (DFG), European Union (EU), Hamburgische Investitions- und F\u00F6rderbank (IFB), Medtronic, Microvention, Route92, Stryker. Consultant for: Acandis, Bayer, Cerenovus, Covidien, Medtronic, Microvention, Penumbra, Phenox, Roche, Stryker, TG Medical. Stockholder: Tegus Medical, Eppdata, Vastrax. Funding Information: Urs Fischer: Research support of the Swiss National Science Foundation and the Swiss Heart Foundation; PI of the ELAN trial, Co-PI of the DISTAL, TECNO, SWIFT DIRECT, SWITCH, ELAPSE and ICARUS trial; research grants from Medtronic (BEYOND SWIFT, SWIFT DIRECT), from Stryker, Rapid medical, Penumbra, Medtronic and Phenox (DISTAL), and from Boehringer Ingelheim (TECNO), whereas all fees were paid to the institution; consultancies for Medtronic, Stryker, and CSL Behring (fees paid to institution); participation in an advisory board for Alexion/Portola, Boehringer Ingelheim, Biogen and Acthera (fees paid to institution); member of a clinical event committee (CEC) of the COATING study (Phenox) and member of the data and safety monitoring committee (DSMB) of the TITAN, LATE_MT and IN EXTREMIS trials; presidency of the Swiss Neurological Society. Funding Information: Marios Psychogios: Grants from the Swiss National Science Foundation (SNF) for the DISTAL trial (33IC30_198783), ICARUS (32003B_220118) and TECNO trial (32003B_204977), Grant from Bangerter-Rhyner Stiftung for the DISTAL trial. Unrestricted Grants for the DISTAL trial from Stryker Neurovascular Inc., Medtronic Inc., Phenox GmbH, Penumbra Inc. and Rapid Medical Inc., Sponsor-PI SPINNERS trial (Funded by a Siemens Healthineers AG Grant), Research agreement with Siemens Healthineers AG, Local PI for the ACT in STROKE, ASSIST, EXCELLENT, TENSION, COATING, SURF and ESCAPE-NEXT trials. Speaker fees: Stryker Neurovascular Inc., Medtronic Inc., Penumbra Inc., Acandis GmbH, Phenox GmbH, Siemens Healthineers AG. Publisher Copyright: © European Stroke Organisation 2024. |
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EnDovascular Therapy Plus Best Medical Treatment (BMT) Versus BMT Alone for MedIum distal VeSsel Occlusion sTroke (DISTAL)An international, multicentre, randomized-controlled, two-arm, assessor-blinded trialdistal vessel occlusionendovascular therapyIschemic strokemechanical thrombectomymedium vessel occlusionClinical NeurologyCardiology and Cardiovascular MedicineFunding Information: The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The trial is supported by public grants from the Swiss National Science Foundation (SNSF grant number 33IC30_198783) and the Gottfried und Julia Bangerter-Rhyner-Stiftung (Basel, Switzerland) as well as through unrestricted grants from Stryker Neurovascular Inc., Medtronic Inc., Phenox GmbH, Rapid Medical Inc., and Penumbra Inc.. The funders had no role in the design, site selection, planning or conduct of the trial and they will have no role in the analysis of the trial data, the writing of the manuscript or the interpretation of the trial data. Funding Information: Jens Fiehler: Research support: German Ministry of Science and Education (BMBF), German Ministry of Economy and Innovation (BMWi), German Research Foundation (DFG), European Union (EU), Hamburgische Investitions- und F\u00F6rderbank (IFB), Medtronic, Microvention, Route92, Stryker. Consultant for: Acandis, Bayer, Cerenovus, Covidien, Medtronic, Microvention, Penumbra, Phenox, Roche, Stryker, TG Medical. Stockholder: Tegus Medical, Eppdata, Vastrax. Funding Information: Urs Fischer: Research support of the Swiss National Science Foundation and the Swiss Heart Foundation; PI of the ELAN trial, Co-PI of the DISTAL, TECNO, SWIFT DIRECT, SWITCH, ELAPSE and ICARUS trial; research grants from Medtronic (BEYOND SWIFT, SWIFT DIRECT), from Stryker, Rapid medical, Penumbra, Medtronic and Phenox (DISTAL), and from Boehringer Ingelheim (TECNO), whereas all fees were paid to the institution; consultancies for Medtronic, Stryker, and CSL Behring (fees paid to institution); participation in an advisory board for Alexion/Portola, Boehringer Ingelheim, Biogen and Acthera (fees paid to institution); member of a clinical event committee (CEC) of the COATING study (Phenox) and member of the data and safety monitoring committee (DSMB) of the TITAN, LATE_MT and IN EXTREMIS trials; presidency of the Swiss Neurological Society. Funding Information: Marios Psychogios: Grants from the Swiss National Science Foundation (SNF) for the DISTAL trial (33IC30_198783), ICARUS (32003B_220118) and TECNO trial (32003B_204977), Grant from Bangerter-Rhyner Stiftung for the DISTAL trial. Unrestricted Grants for the DISTAL trial from Stryker Neurovascular Inc., Medtronic Inc., Phenox GmbH, Penumbra Inc. and Rapid Medical Inc., Sponsor-PI SPINNERS trial (Funded by a Siemens Healthineers AG Grant), Research agreement with Siemens Healthineers AG, Local PI for the ACT in STROKE, ASSIST, EXCELLENT, TENSION, COATING, SURF and ESCAPE-NEXT trials. Speaker fees: Stryker Neurovascular Inc., Medtronic Inc., Penumbra Inc., Acandis GmbH, Phenox GmbH, Siemens Healthineers AG. Publisher Copyright: © European Stroke Organisation 2024.Rationale: Whether endovascular therapy (EVT) in addition to best medical treatment (BMT) in people with acute ischemic stroke (AIS) due to a medium distal vessel occlusion (MDVO) is beneficial remains unclear. Aim: To determine if people experiencing an AIS due to an isolated MDVO (defined as the co- or non-dominant M2 segment, the M3 or M4 segment of the middle cerebral artery, the A1, A2, or A3 segment of the anterior cerebral artery or the P1, P2 or P3 segment of the posterior cerebral artery) will have superior outcome if treated with EVT in addition to BMT compared to BMT alone. Sample size: To randomize 526 participants 1:1 to EVT plus BMT or BMT alone. Methods and design: A multicentre, international, prospective, randomized, open-label, blinded-endpoint (PROBE) superiority trial. Outcomes: The primary efficacy endpoint is the distribution of disability levels on the modified Rankin Scale at 90 days. Secondary clinical efficacy outcomes include normalized change in National Institutes of Health Stroke Scale score from baseline to day 1, cognitive outcome at 90 days, and health-related quality of life at 90 days. Safety outcomes include all serious adverse events, symptomatic intracranial hemorrhage within 24 h, and all-cause mortality up to 90 days. Secondary imaging outcomes include successful reperfusion at end of EVT procedure and recanalization of target artery at 24 h. Discussion: DISTAL will inform physicians whether EVT in addition to BMT in people with AIS due to a MDVO is more efficacious than BMT alone.NOVA Medical School|Faculdade de Ciências Médicas (NMS|FCM)RUNMarios-Nikos, PsychogiosAlex, BrehmJens, FiehlerIsabel, FragataJan, GrallaMira, KatanRonen, LekerPaolo, MachiMarc, RiboJeffrey L, SaverDaniel, StrbianAdriaan, van EsClaus, ZimmerNikki, RommersLuzia, BalmerUrs, Fischer2024-05-25T00:37:31Z2024-122024-12-01T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfhttp://hdl.handle.net/10362/167821eng2396-9873PURE: 91396528https://doi.org/10.1177/23969873241250212info:eu-repo/semantics/openAccessreponame:Repositórios Científicos de Acesso Aberto de Portugal (RCAAP)instname:FCCN, serviços digitais da FCT – Fundação para a Ciência e a Tecnologiainstacron:RCAAP2025-01-13T01:40:08Zoai:run.unl.pt:10362/167821Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireinfo@rcaap.ptopendoar:https://opendoar.ac.uk/repository/71602025-05-28T17:52:30.750590Repositórios Científicos de Acesso Aberto de Portugal (RCAAP) - FCCN, serviços digitais da FCT – Fundação para a Ciência e a Tecnologiafalse |
dc.title.none.fl_str_mv |
EnDovascular Therapy Plus Best Medical Treatment (BMT) Versus BMT Alone for MedIum distal VeSsel Occlusion sTroke (DISTAL) An international, multicentre, randomized-controlled, two-arm, assessor-blinded trial |
title |
EnDovascular Therapy Plus Best Medical Treatment (BMT) Versus BMT Alone for MedIum distal VeSsel Occlusion sTroke (DISTAL) |
spellingShingle |
EnDovascular Therapy Plus Best Medical Treatment (BMT) Versus BMT Alone for MedIum distal VeSsel Occlusion sTroke (DISTAL) Marios-Nikos, Psychogios distal vessel occlusion endovascular therapy Ischemic stroke mechanical thrombectomy medium vessel occlusion Clinical Neurology Cardiology and Cardiovascular Medicine |
title_short |
EnDovascular Therapy Plus Best Medical Treatment (BMT) Versus BMT Alone for MedIum distal VeSsel Occlusion sTroke (DISTAL) |
title_full |
EnDovascular Therapy Plus Best Medical Treatment (BMT) Versus BMT Alone for MedIum distal VeSsel Occlusion sTroke (DISTAL) |
title_fullStr |
EnDovascular Therapy Plus Best Medical Treatment (BMT) Versus BMT Alone for MedIum distal VeSsel Occlusion sTroke (DISTAL) |
title_full_unstemmed |
EnDovascular Therapy Plus Best Medical Treatment (BMT) Versus BMT Alone for MedIum distal VeSsel Occlusion sTroke (DISTAL) |
title_sort |
EnDovascular Therapy Plus Best Medical Treatment (BMT) Versus BMT Alone for MedIum distal VeSsel Occlusion sTroke (DISTAL) |
author |
Marios-Nikos, Psychogios |
author_facet |
Marios-Nikos, Psychogios Alex, Brehm Jens, Fiehler Isabel, Fragata Jan, Gralla Mira, Katan Ronen, Leker Paolo, Machi Marc, Ribo Jeffrey L, Saver Daniel, Strbian Adriaan, van Es Claus, Zimmer Nikki, Rommers Luzia, Balmer Urs, Fischer |
author_role |
author |
author2 |
Alex, Brehm Jens, Fiehler Isabel, Fragata Jan, Gralla Mira, Katan Ronen, Leker Paolo, Machi Marc, Ribo Jeffrey L, Saver Daniel, Strbian Adriaan, van Es Claus, Zimmer Nikki, Rommers Luzia, Balmer Urs, Fischer |
author2_role |
author author author author author author author author author author author author author author author |
dc.contributor.none.fl_str_mv |
NOVA Medical School|Faculdade de Ciências Médicas (NMS|FCM) RUN |
dc.contributor.author.fl_str_mv |
Marios-Nikos, Psychogios Alex, Brehm Jens, Fiehler Isabel, Fragata Jan, Gralla Mira, Katan Ronen, Leker Paolo, Machi Marc, Ribo Jeffrey L, Saver Daniel, Strbian Adriaan, van Es Claus, Zimmer Nikki, Rommers Luzia, Balmer Urs, Fischer |
dc.subject.por.fl_str_mv |
distal vessel occlusion endovascular therapy Ischemic stroke mechanical thrombectomy medium vessel occlusion Clinical Neurology Cardiology and Cardiovascular Medicine |
topic |
distal vessel occlusion endovascular therapy Ischemic stroke mechanical thrombectomy medium vessel occlusion Clinical Neurology Cardiology and Cardiovascular Medicine |
description |
Funding Information: The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The trial is supported by public grants from the Swiss National Science Foundation (SNSF grant number 33IC30_198783) and the Gottfried und Julia Bangerter-Rhyner-Stiftung (Basel, Switzerland) as well as through unrestricted grants from Stryker Neurovascular Inc., Medtronic Inc., Phenox GmbH, Rapid Medical Inc., and Penumbra Inc.. The funders had no role in the design, site selection, planning or conduct of the trial and they will have no role in the analysis of the trial data, the writing of the manuscript or the interpretation of the trial data. Funding Information: Jens Fiehler: Research support: German Ministry of Science and Education (BMBF), German Ministry of Economy and Innovation (BMWi), German Research Foundation (DFG), European Union (EU), Hamburgische Investitions- und F\u00F6rderbank (IFB), Medtronic, Microvention, Route92, Stryker. Consultant for: Acandis, Bayer, Cerenovus, Covidien, Medtronic, Microvention, Penumbra, Phenox, Roche, Stryker, TG Medical. Stockholder: Tegus Medical, Eppdata, Vastrax. Funding Information: Urs Fischer: Research support of the Swiss National Science Foundation and the Swiss Heart Foundation; PI of the ELAN trial, Co-PI of the DISTAL, TECNO, SWIFT DIRECT, SWITCH, ELAPSE and ICARUS trial; research grants from Medtronic (BEYOND SWIFT, SWIFT DIRECT), from Stryker, Rapid medical, Penumbra, Medtronic and Phenox (DISTAL), and from Boehringer Ingelheim (TECNO), whereas all fees were paid to the institution; consultancies for Medtronic, Stryker, and CSL Behring (fees paid to institution); participation in an advisory board for Alexion/Portola, Boehringer Ingelheim, Biogen and Acthera (fees paid to institution); member of a clinical event committee (CEC) of the COATING study (Phenox) and member of the data and safety monitoring committee (DSMB) of the TITAN, LATE_MT and IN EXTREMIS trials; presidency of the Swiss Neurological Society. Funding Information: Marios Psychogios: Grants from the Swiss National Science Foundation (SNF) for the DISTAL trial (33IC30_198783), ICARUS (32003B_220118) and TECNO trial (32003B_204977), Grant from Bangerter-Rhyner Stiftung for the DISTAL trial. Unrestricted Grants for the DISTAL trial from Stryker Neurovascular Inc., Medtronic Inc., Phenox GmbH, Penumbra Inc. and Rapid Medical Inc., Sponsor-PI SPINNERS trial (Funded by a Siemens Healthineers AG Grant), Research agreement with Siemens Healthineers AG, Local PI for the ACT in STROKE, ASSIST, EXCELLENT, TENSION, COATING, SURF and ESCAPE-NEXT trials. Speaker fees: Stryker Neurovascular Inc., Medtronic Inc., Penumbra Inc., Acandis GmbH, Phenox GmbH, Siemens Healthineers AG. Publisher Copyright: © European Stroke Organisation 2024. |
publishDate |
2024 |
dc.date.none.fl_str_mv |
2024-05-25T00:37:31Z 2024-12 2024-12-01T00:00:00Z |
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info:eu-repo/semantics/publishedVersion |
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