Scandinavian Trial of Uncomplicated Aortic Dissection Therapy

Launched by UNIVERSITY OF AARHUS · Jan 17, 2022

Keywords

ClinConnect Summary

The Scandinavian Trial of Uncomplicated Aortic Dissection Therapy is studying whether a specific procedure called thoracic endovascular aortic repair (TEVAR) can improve survival rates for patients with uncomplicated type B aortic dissections (uTBAD). TEVAR is a minimally invasive surgery that provides treatment for issues with the thoracic aorta, which is the large blood vessel running from the heart down to the abdomen. In this trial, patients will be randomly assigned to receive either standard medical treatment or standard treatment plus TEVAR. The primary goal of the study is to see how many patients survive after five years, while other important factors like quality of life and related health issues will also be monitored.

To participate in the trial, individuals must be 18 years or older and diagnosed with uTBAD that is less than four weeks old. Some people may not be eligible, such as those with more complicated aortic dissections, previous aortic surgeries, or certain health conditions like severe connective tissue diseases. The trial is currently recruiting participants from various medical centers in Scandinavia and aims to enroll around 554 patients over the next two to three years. If you or a loved one are considering participation, you'll receive detailed information about what to expect, including the potential benefits and risks of the treatments being studied.

Gender

ALL

Eligibility 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.