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Scandinavian trial of uncomplicated aortic dissection therapy : study protocol for a randomized controlled trial

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dc.contributor.author Rudolph, Claudina
dc.contributor.author Lindberg, Beate Rikken
dc.contributor.author Resch, Timothy
dc.contributor.author Mani, Kevin
dc.contributor.author Björkman, Patrick
dc.contributor.author Laxdal, Elín Hanna
dc.contributor.author Støvring, Henrik
dc.contributor.author Beck, Henriette Margrethe
dc.contributor.author Eriksson, Gunnar
dc.contributor.author Budtz-Lilly, Jacob
dc.date.accessioned 2023-04-06T01:04:50Z
dc.date.available 2023-04-06T01:04:50Z
dc.date.issued 2023-03-23
dc.identifier.citation Rudolph , C , Lindberg , B R , Resch , T , Mani , K , Björkman , P , Laxdal , E H , Støvring , H , Beck , H M , Eriksson , G & Budtz-Lilly , J 2023 , ' Scandinavian trial of uncomplicated aortic dissection therapy : study protocol for a randomized controlled trial ' , Trials , vol. 24 , no. 1 , 217 , pp. 217 . https://doi.org/10.1186/s13063-023-07255-7
dc.identifier.issn 1745-6215
dc.identifier.other PURE: 114012016
dc.identifier.other PURE UUID: 82a5985c-da77-4f58-9f69-51a294fc3004
dc.identifier.other Scopus: 85150790204
dc.identifier.other unpaywall: 10.1186/s13063-023-07255-7
dc.identifier.uri https://hdl.handle.net/20.500.11815/4138
dc.description Publisher Copyright: © 2023, The Author(s).
dc.description.abstract BACKGROUND: Contemporary management of uncomplicated type B aortic dissections (uTBAD) is based on the acuity and various morphological features. Medical therapy is mandatory, while the risks of early thoracic endovascular aortic repair (TEVAR) are balanced against the potential for rupture, complex surgery, and death. Improved aortic morphology following TEVAR is documented, but evidence for improved overall survival is lacking. The costs and impact on quality of life are also needed. METHODS: The trial is a randomized, open-label, superiority clinical trial with parallel assignment of subjects at 23 clinical sites in Denmark, Norway, Sweden, Finland, and Iceland. Eligibility includes patients aged ≥ 18 with uTBAD of < 4 weeks duration. Recruited subjects will be randomized to either standard medical therapy (SMT) or SMT + TEVAR, where TEVAR must be performed between 2-12 weeks from the onset of symptoms. DISCUSSION: This trial will evaluate the primary question of whether early TEVAR improves survival at 5 years among uTBAD patients. Moreover, the costs and the impact on quality of life should provide sorely needed data on other factors that play a role in treatment strategy decisions. The common Nordic healthcare model, with inclusion of all aortic centers, provides a favorable setting for carrying out this trial, while the robust healthcare registries ensure data validity. TRIAL REGISTRATION: ClinicalTrials.gov NCT05215587. Registered on January 31, 2022.
dc.format.extent 217
dc.language.iso en
dc.relation.ispartofseries Trials; 24(1)
dc.rights info:eu-repo/semantics/openAccess
dc.subject Æðaskurðlæknisfræði
dc.subject Aneurysm, Dissecting
dc.subject Aortic dissection
dc.subject Stent graft
dc.subject TEVAR
dc.subject Type B
dc.subject Uncomplicated
dc.subject Blood Vessel Prosthesis Implantation/adverse effects
dc.subject Humans
dc.subject Endovascular Procedures/adverse effects
dc.subject Risk Factors
dc.subject Aortic Dissection/surgery
dc.subject Treatment Outcome
dc.subject Aortic Aneurysm, Thoracic/diagnostic imaging
dc.subject Randomized Controlled Trials as Topic
dc.subject Quality of Life
dc.subject Retrospective Studies
dc.subject Stents
dc.subject Pharmacology (medical)
dc.subject Medicine (miscellaneous)
dc.title Scandinavian trial of uncomplicated aortic dissection therapy : study protocol for a randomized controlled trial
dc.type /dk/atira/pure/researchoutput/researchoutputtypes/contributiontojournal/article
dc.description.version Peer reviewed
dc.identifier.pmid 36949478
dc.identifier.doi https://doi.org/10.1186/s13063-023-07255-7
dc.relation.url http://www.scopus.com/inward/record.url?scp=85150790204&partnerID=8YFLogxK
dc.contributor.department Other departments

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