Frequently Asked Questions
What is an Aortic Dissection?
An aortic dissection is a tear in the aorta, the main artery that carries blood from the heart to the body (Figure 1). It causes severe back pain, but sometimes in the chest or abdomen.
Medical evaluation and treatment are essential. Depending on test results, immediate surgery may be needed, or doctors may opt for monitoring. A dissection is “complicated” if it is life-threatening or causes severe symptoms, while "uncomplicated" means it is not immediately dangerous but still requires careful management.
Treatment Options
Aortic dissections are managed with medications and, in some cases, surgery. The main surgical procedure, TEVAR (Thoracic Endovascular Aortic Repair), involves placing a stent in the aorta to cover the tear, relieve pain, and prevent further damage. (Figure 2)
What is a TEVAR?
As mentioned above, a TEVAR is a type of stent with a covering fabric that can be placed in the aorta to cover the tear. See Figures 1 and 2 for a graphical representation. TEVAR stands for Thoracic Endovascular Aortic Repair.
What is a Randomized Controlled Trial?
A randomized controlled trial (RCT) compares different treatments or approaches in a fairand unbiased way. It ensures that patients receive safe, standard care while allowing researchers to determine the best treatment strategy.
The SUNDAY Trial (Scandinavian trial of UNcomplicateD AorticDissection TherapY)
This study investigates whether early surgical intervention improves survival for patients with uncomplicated aortic dissection. Since the best treatment approach is uncertain, this trial will compare early surgery with regular medical monitoring. It will also evaluate quality of life, safety, costs, and the need for additional procedures.
This is not an Experimental Treatment
This trial does not introduce new medications or devices. It follows all international treatment guidelines and strictly tests whether early surgery is beneficial.
Where is the Trial Conducted?
The trial was initiated by the Nordic countries, and it is expanding to major aortic centers across Europe and Australasia.
Timeline
Recruitment will take about three to five years, with follow-up up to 5 years after all patients are included. Final results are expected within 8-10 years.
Voluntary Participation
Participation is entirely voluntary. Before joining, you will have a discussion with a medical team and need to provide written consent. You can withdraw at any time or choose to participate in only certain aspects.
Privacy and Data Security
Your personal data is stored securely at the local hospital and a protected database at Aarhus University, Denmark. Your identity is kept confidential, and strict privacy regulations are enforced.
Benefits and Risks
There are no direct financial or healthcare benefits for participants, but the trial helps improve future treatment.
To date, either an intervention in the form of a TEVAR (a stent in your aorta) or medical and conservative therapy are considered as equivalent. Randomization ensures that all participants receive safe and accepted treatment options.
Does the trial involve any new or extra examinations for me as a patient?
All trial participants receive a blood pressure monitoring device to check their blood pressure at home and report this to the trial nurse. Trial participants are also asked to fill out health related questionnaires at certain intervals. Participation in the trial does not require any extra examinations in addition to this.
What is the trial-specific contacts for individuals participating in the trial?
Individuals included in the trial have contact with the trial coordinators at inclusion,
intervention (if randomized to TEVAR), 3 months, 1 year, 3 years and 5 years (Figure 3).
This is the minimum requirement, and obviously more follow-up may be necessary, depending on what you and your medical team decide.
Eligibility
Some health conditions may automatically disqualify you from the trial. If you have questions about your eligibility, contact the nearest center.
Ethical Approval and Safety
The trial is approved by ethical committees in all participating countries, and a special safety committee monitors patient well-being. National health authorities also have the opportunity to evaluate and intervene at any point.
If Issues Arise
If you experience any problems, speak with your medical team, family doctor, or a member of the steering committee.
Access to Results
Preliminary findings will be posted on the trial’s website. If you requested to receive updates when joining the trial, your preference will be honored. For any other questions, contact your nearest center or a steering committee member.
Do you want to know more about the SUNDAY Trial?
Click below to read more about our team and our fully investigator-initiated approach
Figures
Figure 3
After enrollment into the study, follow-up information will be asked from participants, including
questionnaires, blood pressure, medication list, and adverse events at 3 months, 1, 3, and 5 years.
Figure 1
Image of the affected portion of the aorta. The tear in the aortic wall results in the separation of the wall layers, and a “true” (bright red) and “false” (dark red) lumen develops. It can lead to aortic rupture, or compression of vessels, which support the vital organs such as bowels and kidneys.
This tear can be covered by a stent, which helps in maintaining the flow in the true lumen.
Figure 2
Sometimes, to achieve adequate treatment of the affected aortic segment, coverage of the left subclavian artery may be necessary. This artery supports the left arm with blood. Coverage of the artery can be performed with or without maintaining direct blood flow from the aorta to the arm
based on the patient’s anatomical characteristics.