Scandinavian trial of uncomplicated aortic dissection therapy:study protocol for a randomized controlled trial
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...
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2023
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Online Access: | https://pure.au.dk/portal/da/publications/scandinavian-trial-of-uncomplicated-aortic-dissection-therapy(bd9228c0-ff01-4b98-aa6f-e4ab1ee5266d).html https://doi.org/10.1186/s13063-023-07255-7 |
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ftuniaarhuspubl:oai:pure.atira.dk:publications/bd9228c0-ff01-4b98-aa6f-e4ab1ee5266d 2023-12-31T10:08:23+01:00 Scandinavian trial of uncomplicated aortic dissection therapy:study protocol for a randomized controlled trial Rudolph, Claudina Lindberg, Beate Rikken Resch, Timothy Mani, Kevin Björkman, Patrick Laxdal, Elín Hanna Støvring, Henrik Beck, Henriette Margrethe Eriksson, Gunnar Budtz-Lilly, Jacob 2023-12 https://pure.au.dk/portal/da/publications/scandinavian-trial-of-uncomplicated-aortic-dissection-therapy(bd9228c0-ff01-4b98-aa6f-e4ab1ee5266d).html https://doi.org/10.1186/s13063-023-07255-7 eng eng https://pure.au.dk/portal/da/publications/scandinavian-trial-of-uncomplicated-aortic-dissection-therapy(bd9228c0-ff01-4b98-aa6f-e4ab1ee5266d).html info:eu-repo/semantics/openAccess 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 . https://doi.org/10.1186/s13063-023-07255-7 Aneurysm Dissecting Aortic dissection Stent graft TEVAR Type B Uncomplicated Blood Vessel Prosthesis Implantation/adverse effects Endovascular Procedures/adverse effects Humans Risk Factors Aortic Dissection/surgery Treatment Outcome Aortic Aneurysm Thoracic/diagnostic imaging Randomized Controlled Trials as Topic Quality of Life Retrospective Studies Stents article 2023 ftuniaarhuspubl https://doi.org/10.1186/s13063-023-07255-7 2023-12-07T00:06:04Z 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. Article in Journal/Newspaper Iceland Aarhus University: Research Trials 24 1 |
institution |
Open Polar |
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Aarhus University: Research |
op_collection_id |
ftuniaarhuspubl |
language |
English |
topic |
Aneurysm Dissecting Aortic dissection Stent graft TEVAR Type B Uncomplicated Blood Vessel Prosthesis Implantation/adverse effects Endovascular Procedures/adverse effects Humans Risk Factors Aortic Dissection/surgery Treatment Outcome Aortic Aneurysm Thoracic/diagnostic imaging Randomized Controlled Trials as Topic Quality of Life Retrospective Studies Stents |
spellingShingle |
Aneurysm Dissecting Aortic dissection Stent graft TEVAR Type B Uncomplicated Blood Vessel Prosthesis Implantation/adverse effects Endovascular Procedures/adverse effects Humans Risk Factors Aortic Dissection/surgery Treatment Outcome Aortic Aneurysm Thoracic/diagnostic imaging Randomized Controlled Trials as Topic Quality of Life Retrospective Studies Stents Rudolph, Claudina Lindberg, Beate Rikken Resch, Timothy Mani, Kevin Björkman, Patrick Laxdal, Elín Hanna Støvring, Henrik Beck, Henriette Margrethe Eriksson, Gunnar Budtz-Lilly, Jacob Scandinavian trial of uncomplicated aortic dissection therapy:study protocol for a randomized controlled trial |
topic_facet |
Aneurysm Dissecting Aortic dissection Stent graft TEVAR Type B Uncomplicated Blood Vessel Prosthesis Implantation/adverse effects Endovascular Procedures/adverse effects Humans Risk Factors Aortic Dissection/surgery Treatment Outcome Aortic Aneurysm Thoracic/diagnostic imaging Randomized Controlled Trials as Topic Quality of Life Retrospective Studies Stents |
description |
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. |
format |
Article in Journal/Newspaper |
author |
Rudolph, Claudina Lindberg, Beate Rikken Resch, Timothy Mani, Kevin Björkman, Patrick Laxdal, Elín Hanna Støvring, Henrik Beck, Henriette Margrethe Eriksson, Gunnar Budtz-Lilly, Jacob |
author_facet |
Rudolph, Claudina Lindberg, Beate Rikken Resch, Timothy Mani, Kevin Björkman, Patrick Laxdal, Elín Hanna Støvring, Henrik Beck, Henriette Margrethe Eriksson, Gunnar Budtz-Lilly, Jacob |
author_sort |
Rudolph, Claudina |
title |
Scandinavian trial of uncomplicated aortic dissection therapy:study protocol for a randomized controlled trial |
title_short |
Scandinavian trial of uncomplicated aortic dissection therapy:study protocol for a randomized controlled trial |
title_full |
Scandinavian trial of uncomplicated aortic dissection therapy:study protocol for a randomized controlled trial |
title_fullStr |
Scandinavian trial of uncomplicated aortic dissection therapy:study protocol for a randomized controlled trial |
title_full_unstemmed |
Scandinavian trial of uncomplicated aortic dissection therapy:study protocol for a randomized controlled trial |
title_sort |
scandinavian trial of uncomplicated aortic dissection therapy:study protocol for a randomized controlled trial |
publishDate |
2023 |
url |
https://pure.au.dk/portal/da/publications/scandinavian-trial-of-uncomplicated-aortic-dissection-therapy(bd9228c0-ff01-4b98-aa6f-e4ab1ee5266d).html https://doi.org/10.1186/s13063-023-07255-7 |
genre |
Iceland |
genre_facet |
Iceland |
op_source |
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 . https://doi.org/10.1186/s13063-023-07255-7 |
op_relation |
https://pure.au.dk/portal/da/publications/scandinavian-trial-of-uncomplicated-aortic-dissection-therapy(bd9228c0-ff01-4b98-aa6f-e4ab1ee5266d).html |
op_rights |
info:eu-repo/semantics/openAccess |
op_doi |
https://doi.org/10.1186/s13063-023-07255-7 |
container_title |
Trials |
container_volume |
24 |
container_issue |
1 |
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1786841090001731584 |