Evaluating TEVAR for uncomplicated aortic dissection
Scandinavian Trial of Uncomplicated Aortic Dissection Therapy
This study is testing if adding a special procedure called TEVAR to standard treatment can help people with uncomplicated aortic dissection live longer and have better health outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 554 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Aarhus Academic / other |
| Locations | 28 sites (Aalborg and 27 other locations) |
| Trial ID | NCT05215587 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of thoracic endovascular aortic repair (TEVAR) in improving 5-year survival rates for patients with uncomplicated Stanford type-B aortic dissection (uTBAD). Participants will be randomly assigned to receive either standard medical therapy alone or standard medical therapy combined with TEVAR. The study aims to provide robust evidence regarding the potential benefits of TEVAR, addressing uncertainties in its use for uncomplicated cases. Secondary outcomes will assess aortic-related mortality, neurological events, quality of life, and healthcare costs.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older with an uncomplicated Stanford type-B aortic dissection diagnosed within the last four weeks.
Not a fit: Patients with complicated aortic dissections, pre-existing aortic conditions requiring intervention, or significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide evidence that TEVAR improves survival and quality of life for patients with uncomplicated aortic dissections.
How similar studies have performed: While there have been analyses suggesting potential benefits of TEVAR, this specific approach for uncomplicated dissections is novel and has not been extensively tested in randomized trials.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Aalborg and 27 other locations
- Aalborg University Hospital — Aalborg, Denmark (Recruiting)
- Aarhus University Hospital — Aarhus, Denmark (Recruiting)
- Copenhagen University Hospital, Rigshospital — Copenhagen, Denmark (Recruiting)
- Odense University Hospital — Odense, Denmark (Recruiting)
- Helsinki University Hospital — Helsinki, Finland (Recruiting)
- Kuopio University Hospital — Kuopio, Finland (Not_yet_recruiting)
- Oulu University Hospital — Oulu, Finland (Not_yet_recruiting)
- Tampere University Hospital — Tampere, Finland (Recruiting)
- Turku University Hospital — Turku, Finland (Recruiting)
- Landspitali University Hospital — Reykjavik, Iceland (Recruiting)
- Amsterdam University Medical Center (AUMC) — Amsterdam, Netherlands (Not_yet_recruiting)
- University Medical Center Groningen (UMCG) — Groningen, Netherlands (Not_yet_recruiting)
- Leiden University Medical Center (LUMC) — Leiden, Netherlands (Recruiting)
- Maastricht University Medical Center (MUMC) — Maastricht, Netherlands (Not_yet_recruiting)
- Radboud University Medical Center (Radboudumc) — Nijmegen, Netherlands (Not_yet_recruiting)
- Erasmus Medical Center (EMC) — Rotterdam, Netherlands (Not_yet_recruiting)
- University Medical Center Utrecht (UMCU) — Utrecht, Netherlands (Not_yet_recruiting)
- Haukeland University Hospital — Bergen, Norway (Recruiting)
- Oslo University Hospital — Oslo, Norway (Recruiting)
- University Hospital Nord — Tromsø, Norway (Recruiting)
- St Olavs Hospital — Trondheim, Norway (Recruiting)
- Sahlgrenska University Hospital — Gothenburg, Sweden (Recruiting)
- Linköping University Hospital — Linköping, Sweden (Recruiting)
- Skånes University Hospital — Malmö, Sweden (Recruiting)
- Örebro University Hospital — Örebro, Sweden (Active_not_recruiting)
- Karolinska University Hospital — Stockholm, Sweden (Recruiting)
- Sodersjukhuset — Stockholm, Sweden (Recruiting)
- Uppsala University Hospital — Uppsala, Sweden (Recruiting)
Study contacts
- Principal investigator: Jacob W Budtz-Lilly, MD PhD — Aarhus University Hospital
- Study coordinator: Jacob W Budtz-Lilly, MD PhD
- Email: jacoblilly@clin.au.dk
- Phone: 45 28147705
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.