Endovascular treatment of aneurysms and platinum coil caliber: study protocol of a randomized, controlled trial
Autor(a) principal: | |
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Data de Publicação: | 2016 |
Outros Autores: | , , , , , , , , |
Tipo de documento: | Artigo |
Idioma: | por |
Título da fonte: | Repositório Institucional da UFRN |
Texto Completo: | https://repositorio.ufrn.br/handle/123456789/52463 https://doi.org/10.1177/1591019916663471 |
Resumo: | BackgroundEndovascular coil embolization of cerebral aneurysms is an effective treatment for the prevention of aneurysm rebleeding after subarachnoid hemorrhage. It is also often used in unruptured aneurysms, but it is associated with aneurysm remnants and recurrences in up to 20%–33% of patients. We hypothesized that better aneurysm occlusion rates can be achieved with coils of larger caliber. MethodsThe Does Embolization with Larger coils lead to better Treatment of Aneurysms (DELTA) trial is an investigator-initiated, multicenter, prospective, randomized, controlled clinical trial. To test the hypothesis that 15-caliber coiling systems are superior to 10-caliber coils, 564 patients with aneurysms measuring 4–12 mm will be randomized 1:1 to embolization with either 10-caliber coils exclusively (control group) or the highest safely achievable proportion of 15-caliber coils (intervention group). The primary efficacy endpoint of the trial is the occurrence of a major recurrence or a residual aneurysm at one year. A pilot phase of 165 patients will be conducted to verify feasibility of the coiling strategy, compliance to treatment allocation, safety of a 15-caliber platinum coil embolization strategy, recruitment rates, and the capacity to improve packing density. DiscussionThe DELTA trial will test the hypothesis that the use of coils of larger caliber can improve angiographic results of endovascular coiling. |
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Ghostine, JimmyKhoury, NaimCloutier, FrancisKotowski, MarcGentric, Jean-ChristopheBatista, André LimaWeill, AlainRoy, DanielDarsaut, Tim ERaymond, Jean2023-05-17T17:55:53Z2023-05-17T17:55:53Z2016-12BATISTA, André Lima, et al. Endovascular treatment of aneurysms and platinum coil caliber: study protocol of a randomized, controlled trial. Interventional Neuroradiology, [S.L.], v. 22, n. 6, p. 693-699, 20 ago. 2016. SAGE Publications. http://dx.doi.org/10.1177/1591019916663471.https://repositorio.ufrn.br/handle/123456789/52463https://doi.org/10.1177/1591019916663471American Society of Neuroradiologycerebral aneurysmendovascular coil embolizationpacking densityrandomizedcontrolled trialEndovascular treatment of aneurysms and platinum coil caliber: study protocol of a randomized, controlled trialinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleBackgroundEndovascular coil embolization of cerebral aneurysms is an effective treatment for the prevention of aneurysm rebleeding after subarachnoid hemorrhage. It is also often used in unruptured aneurysms, but it is associated with aneurysm remnants and recurrences in up to 20%–33% of patients. We hypothesized that better aneurysm occlusion rates can be achieved with coils of larger caliber. MethodsThe Does Embolization with Larger coils lead to better Treatment of Aneurysms (DELTA) trial is an investigator-initiated, multicenter, prospective, randomized, controlled clinical trial. To test the hypothesis that 15-caliber coiling systems are superior to 10-caliber coils, 564 patients with aneurysms measuring 4–12 mm will be randomized 1:1 to embolization with either 10-caliber coils exclusively (control group) or the highest safely achievable proportion of 15-caliber coils (intervention group). The primary efficacy endpoint of the trial is the occurrence of a major recurrence or a residual aneurysm at one year. A pilot phase of 165 patients will be conducted to verify feasibility of the coiling strategy, compliance to treatment allocation, safety of a 15-caliber platinum coil embolization strategy, recruitment rates, and the capacity to improve packing density. DiscussionThe DELTA trial will test the hypothesis that the use of coils of larger caliber can improve angiographic results of endovascular coiling.porreponame:Repositório Institucional da UFRNinstname:Universidade Federal do Rio Grande do Norte (UFRN)instacron:UFRNinfo:eu-repo/semantics/openAccessLICENSElicense.txtlicense.txttext/plain; charset=utf-81484https://repositorio.ufrn.br/bitstream/123456789/52463/2/license.txte9597aa2854d128fd968be5edc8a28d9MD52123456789/524632023-05-17 14:56:09.63oai:https://repositorio.ufrn.br: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Repositório de PublicaçõesPUBhttp://repositorio.ufrn.br/oai/opendoar:2023-05-17T17:56:09Repositório Institucional da UFRN - Universidade Federal do Rio Grande do Norte (UFRN)false |
dc.title.pt_BR.fl_str_mv |
Endovascular treatment of aneurysms and platinum coil caliber: study protocol of a randomized, controlled trial |
title |
Endovascular treatment of aneurysms and platinum coil caliber: study protocol of a randomized, controlled trial |
spellingShingle |
Endovascular treatment of aneurysms and platinum coil caliber: study protocol of a randomized, controlled trial Ghostine, Jimmy cerebral aneurysm endovascular coil embolization packing density randomized controlled trial |
title_short |
Endovascular treatment of aneurysms and platinum coil caliber: study protocol of a randomized, controlled trial |
title_full |
Endovascular treatment of aneurysms and platinum coil caliber: study protocol of a randomized, controlled trial |
title_fullStr |
Endovascular treatment of aneurysms and platinum coil caliber: study protocol of a randomized, controlled trial |
title_full_unstemmed |
Endovascular treatment of aneurysms and platinum coil caliber: study protocol of a randomized, controlled trial |
title_sort |
Endovascular treatment of aneurysms and platinum coil caliber: study protocol of a randomized, controlled trial |
author |
Ghostine, Jimmy |
author_facet |
Ghostine, Jimmy Khoury, Naim Cloutier, Francis Kotowski, Marc Gentric, Jean-Christophe Batista, André Lima Weill, Alain Roy, Daniel Darsaut, Tim E Raymond, Jean |
author_role |
author |
author2 |
Khoury, Naim Cloutier, Francis Kotowski, Marc Gentric, Jean-Christophe Batista, André Lima Weill, Alain Roy, Daniel Darsaut, Tim E Raymond, Jean |
author2_role |
author author author author author author author author author |
dc.contributor.author.fl_str_mv |
Ghostine, Jimmy Khoury, Naim Cloutier, Francis Kotowski, Marc Gentric, Jean-Christophe Batista, André Lima Weill, Alain Roy, Daniel Darsaut, Tim E Raymond, Jean |
dc.subject.por.fl_str_mv |
cerebral aneurysm endovascular coil embolization packing density randomized controlled trial |
topic |
cerebral aneurysm endovascular coil embolization packing density randomized controlled trial |
description |
BackgroundEndovascular coil embolization of cerebral aneurysms is an effective treatment for the prevention of aneurysm rebleeding after subarachnoid hemorrhage. It is also often used in unruptured aneurysms, but it is associated with aneurysm remnants and recurrences in up to 20%–33% of patients. We hypothesized that better aneurysm occlusion rates can be achieved with coils of larger caliber. MethodsThe Does Embolization with Larger coils lead to better Treatment of Aneurysms (DELTA) trial is an investigator-initiated, multicenter, prospective, randomized, controlled clinical trial. To test the hypothesis that 15-caliber coiling systems are superior to 10-caliber coils, 564 patients with aneurysms measuring 4–12 mm will be randomized 1:1 to embolization with either 10-caliber coils exclusively (control group) or the highest safely achievable proportion of 15-caliber coils (intervention group). The primary efficacy endpoint of the trial is the occurrence of a major recurrence or a residual aneurysm at one year. A pilot phase of 165 patients will be conducted to verify feasibility of the coiling strategy, compliance to treatment allocation, safety of a 15-caliber platinum coil embolization strategy, recruitment rates, and the capacity to improve packing density. DiscussionThe DELTA trial will test the hypothesis that the use of coils of larger caliber can improve angiographic results of endovascular coiling. |
publishDate |
2016 |
dc.date.issued.fl_str_mv |
2016-12 |
dc.date.accessioned.fl_str_mv |
2023-05-17T17:55:53Z |
dc.date.available.fl_str_mv |
2023-05-17T17:55:53Z |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
format |
article |
status_str |
publishedVersion |
dc.identifier.citation.fl_str_mv |
BATISTA, André Lima, et al. Endovascular treatment of aneurysms and platinum coil caliber: study protocol of a randomized, controlled trial. Interventional Neuroradiology, [S.L.], v. 22, n. 6, p. 693-699, 20 ago. 2016. SAGE Publications. http://dx.doi.org/10.1177/1591019916663471. |
dc.identifier.uri.fl_str_mv |
https://repositorio.ufrn.br/handle/123456789/52463 |
dc.identifier.doi.none.fl_str_mv |
https://doi.org/10.1177/1591019916663471 |
identifier_str_mv |
BATISTA, André Lima, et al. Endovascular treatment of aneurysms and platinum coil caliber: study protocol of a randomized, controlled trial. Interventional Neuroradiology, [S.L.], v. 22, n. 6, p. 693-699, 20 ago. 2016. SAGE Publications. http://dx.doi.org/10.1177/1591019916663471. |
url |
https://repositorio.ufrn.br/handle/123456789/52463 https://doi.org/10.1177/1591019916663471 |
dc.language.iso.fl_str_mv |
por |
language |
por |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.publisher.none.fl_str_mv |
American Society of Neuroradiology |
publisher.none.fl_str_mv |
American Society of Neuroradiology |
dc.source.none.fl_str_mv |
reponame:Repositório Institucional da UFRN instname:Universidade Federal do Rio Grande do Norte (UFRN) instacron:UFRN |
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Universidade Federal do Rio Grande do Norte (UFRN) |
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UFRN |
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UFRN |
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Repositório Institucional da UFRN |
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Repositório Institucional da UFRN |
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