Scandinavian Trial of Uncomplicated Aortic Dissection Therapy

Status: Recruiting
Location: See all (28) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Denmark
Aalborg University Hospital
RECRUITING
Aalborg
Aarhus University Hospital
RECRUITING
Aarhus
Copenhagen University Hospital, Rigshospital
RECRUITING
Copenhagen
Odense University Hospital
RECRUITING
Odense
Finland
Helsinki University Hospital
RECRUITING
Helsinki
Kuopio University Hospital
NOT_YET_RECRUITING
Kuopio
Oulu University Hospital
NOT_YET_RECRUITING
Oulu
Tampere University Hospital
RECRUITING
Tampere
Turku University Hospital
RECRUITING
Turku
Iceland
Landspitali University Hospital
RECRUITING
Reykjavik
Netherlands
Amsterdam University Medical Center (AUMC)
NOT_YET_RECRUITING
Amsterdam
University Medical Center Groningen (UMCG)
NOT_YET_RECRUITING
Groningen
Leiden University Medical Center (LUMC)
RECRUITING
Leiden
Maastricht University Medical Center (MUMC)
NOT_YET_RECRUITING
Maastricht
Radboud University Medical Center (Radboudumc)
NOT_YET_RECRUITING
Nijmegen
Erasmus Medical Center (EMC)
NOT_YET_RECRUITING
Rotterdam
University Medical Center Utrecht (UMCU)
NOT_YET_RECRUITING
Utrecht
Norway
Haukeland University Hospital
RECRUITING
Bergen
Oslo University Hospital
RECRUITING
Oslo
University Hospital Nord
RECRUITING
Tromsø
St Olavs Hospital
RECRUITING
Trondheim
Sweden
Sahlgrenska University Hospital
RECRUITING
Gothenburg
Linköping University Hospital
RECRUITING
Linköping
Skånes University Hospital
RECRUITING
Malmo
Örebro University Hospital
ACTIVE_NOT_RECRUITING
Örebro
Karolinska University Hospital
RECRUITING
Stockholm
Sodersjukhuset
RECRUITING
Stockholm
Uppsala University Hospital
RECRUITING
Uppsala
Contact Information
Primary
Jacob W Budtz-Lilly, MD PhD
jacoblilly@clin.au.dk
45 28147705
Time Frame
Start Date: 2023-05-24
Estimated Completion Date: 2030-12-31
Participants
Target number of participants: 554
Treatments
No_intervention: Medical Therapy
Patients will be treated with standard medical therapy, i.e., antihypertensives, pulse-rate regulators, and pain medication.
Active_comparator: Stent Therapy
Patients will be treated with both standard medical therapy, in addition to placement of a thoracic endovascular aortic repair stent graft.
Related Therapeutic Areas
Sponsors
Leads: University of Aarhus
Collaborators: Swedish Heart Lung Foundation, The Swedish Research Council

This content was sourced from clinicaltrials.gov