Status:
RECRUITING
Scandinavian Trial of Uncomplicated Aortic Dissection Therapy
Lead Sponsor:
University of Aarhus
Collaborating Sponsors:
The Swedish Research Council
Swedish Heart Lung Foundation
Conditions:
Aortic Dissection
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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" TBA...
Detailed Description
This randomized, open-label, two-armed controlled study addresses the question of whether thoracic endovascular aortic repair (TEVAR) alters 5-year survival among patients with an uncomplicated Stanfo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 24 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
554 Patients enrolled
Trial Details
Trial ID
NCT05215587
Start Date
May 24 2023
End Date
December 31 2030
Last Update
August 11 2025
Active Locations (28)
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1
Aalborg University Hospital
Aalborg, Denmark
2
Aarhus University Hospital
Aarhus, Denmark, 8200
3
Copenhagen University Hospital, Rigshospital
Copenhagen, Denmark
4
Odense University Hospital
Odense, Denmark