Scandinavian Trial of Uncomplicated Aortic Dissection Therapy

Recruiting now · Not applicable

Conditions studied: Aortic Dissection

In brief

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 Vascular Surgery. This randomized, open-label, two-armed controlled study directly addresses this question of whether TEVAR alters 5-year survival among patients with an uTBAD. Patients will be randomized to either standard medical therapy (SMT) alone or TEVAR in addition to SMT. The primary outcome is 5-year survival, while secondary outcomes include aortic-related mortality, neurological events, quality of life, costs, re interventions and readmissions. in addition, subgroup analyses based on the extent of treatment. Sample size calculations based on previous reports indicate the need to include approximately 554 patients. Patients will be recruited from multiple centres in Scandinavia. Based on the population (24 million) and incidence of uTBAD (approximately 480 per year), and depending on the total number of participating centres, a conservative estimate of two to three years is required for enrolment.

Key facts

Study ID

NCT05215587

Run by

University of Aarhus

People needed

554

Starts

2023-05-24

Expected to finish

2030-12-31

Last updated by the study team

2025-08-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Aalborg University Hospital — Aalborg, Denmark (enrolling)
• Aarhus University Hospital — Aarhus, Denmark (enrolling)
• Copenhagen University Hospital, Rigshospital — Copenhagen, Denmark (enrolling)
• Odense University Hospital — Odense, Denmark (enrolling)
• Helsinki University Hospital — Helsinki, Finland (enrolling)
• Oslo University Hospital — Oslo, Norway (enrolling)
• University Hospital Nord — Tromsø, Norway (enrolling)
• St Olavs Hospital — Trondheim, Norway (enrolling)
• Sahlgrenska University Hospital — Gothenburg, Sweden (enrolling)
• Linköping University Hospital — Linköping, Sweden (enrolling)
• Skånes University Hospital — Malmö, Sweden (enrolling)
• Karolinska University Hospital — Stockholm, Sweden (enrolling)
• Sodersjukhuset — Stockholm, Sweden (enrolling)
• Uppsala University Hospital — Uppsala, Sweden (enrolling)
• Tampere University Hospital — Tampere, Finland (enrolling)
• Turku University Hospital — Turku, Finland (enrolling)
• Landspitali University Hospital — Reykjavik, Iceland (enrolling)
• Leiden University Medical Center (LUMC) — Leiden, Netherlands (enrolling)
• Haukeland University Hospital — Bergen, Norway (enrolling)
• Kuopio University Hospital — Kuopio, Finland
• Oulu University Hospital — Oulu, Finland
• Radboud University Medical Center (Radboudumc) — Nijmegen, Netherlands
• Erasmus Medical Center (EMC) — Rotterdam, Netherlands
• University Medical Center Utrecht (UMCU) — Utrecht, Netherlands
• Amsterdam University Medical Center (AUMC) — Amsterdam, Netherlands

Full record on ClinicalTrials.gov

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