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Scandinavian Trial of Uncomplicated Aortic Dissection Therapy

RecruitingNAAges 18 Years - anyAllUniversity of Aarhus
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In plain words

What the trial is, and whether it could suit you

The introduction of thoracic endovascular aortic repair (TEVAR) in 1994 has radically changed the treatment of thoracic aortic pathology, and TEVAR is now the recommended therapy for "complicated" TBADs and other thoracic aorta diseases. To date, the use of TEVAR in the treatment of "uncomplicated" dissections (uTBAD) is uncertain, although it is presumed that a prophylactic procedure can prevent later complex surgery and early death. Several analyses have found that TEVAR confers improved aortic remodeling and possibly survival, although these were underpowered for this specific outcome. In addition, there are several reports regarding the uncertain benefit or harm of this intervention in the vascular surgery community. Put another way, there is equipoise, and the need for robust evidence in the form of a randomized clinical trial has been clearly iterated by the European Society of Vas

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: All subjects, aged 18 or greater at the time of informed consent, admitted or referred to the participating vascular surgery site with an uTBAD of less than four weeks duration. Exclusion Criteria: * Subjects with no signed informed consent. * Subjects presenting with a complicated type B aortic dissection according to the above definition. * Subjects previously treated in their descending aorta, either open surgery or TEVAR. * Subjects with pre-existing thoracoabdominal aortic aneurysm. * Subjects with other aortic pathology with an indication for intervention that requires TEVAR. * Subjects with traumatic aortic dissections. * Subjects with an established connective tissue disease at the time of randomization, including but not limited to Marfans and Loeys-Dietz syndrome. * Subjects with a clinically estimated life expectancy \< 2 years. * Subjects with dementia. * Pregnant or nursing subjects. * Subjects with current sepsis. * Subjects currently participating in other clinical interventional trials.
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What it tests

  • TEVAR
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Where

28 sites
Aalborg University Hospital
Aalborg, Denmark
Aarhus University Hospital
Aarhus, Denmark
Copenhagen University Hospital, Rigshospital
Copenhagen, Denmark
Odense University Hospital
Odense, Denmark
Helsinki University Hospital
Helsinki, Finland
Kuopio University Hospital
Kuopio, Finland
Oulu University Hospital
Oulu, Finland
Tampere University Hospital
Tampere, Finland

โ€ฆand 20 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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