Early aortic repair in patients needing endovascular/open surgery for type B aortic dissection (EARNEST)

Plain English summary of protocol

Background and study aims
Uncomplicated Type B Aortic Dissection (uTBAD) is a serious condition where the inner layer of the aorta tears, which can lead to long-term complications like aneurysms, aortic rupture, or further dissection. The standard treatment focuses on managing blood pressure, but some patients still face life-threatening issues over time. Thoracic Endovascular Aortic Repair (TEVAR) is a minimally invasive procedure that uses a stent to reinforce the aorta, potentially reducing these risks. The EARNEST trial aims to find out if early TEVAR, done within three months of the initial dissection, improves patient outcomes compared to standard medical management alone.

Who can participate?
Patients with uTBAD who are 5 days to 3 months post-hospital admission for the initial event may be eligible to participate. Participants must be at least 18 years old, have a life expectancy of at least 2 years, and not require high-dependency or critical care treatment. They must also not have received opiate analgesia or similar sedative medication that may impair consciousness or decision-making for at least 48 hours prior to enrolment, and must be willing and able to provide written informed consent.

What does the study involve?
This is a randomised controlled trial, meaning participants are randomly assigned to one of two groups by a computer. One group will receive a stent (TEVAR), while the other will receive standard care. All participants will receive standard UK care, including blood pressure monitoring and medication as needed. Those in the stented group will have the procedure between 5 days and 3 months after dissection. Follow-up visits will occur at 6 weeks, 6 months, and annually, with health assessments and questionnaires. Regular CT or MRI scans will monitor the aorta and any stents.

What are the possible benefits and risks of participating?
Participating in this trial may offer potential benefits, such as better overall outcomes from early TEVAR, though this cannot be guaranteed. The study aims to improve treatment for all patients with dissection in the future. Participants will have regular health check-ups and imaging, and any incidental findings will be reported to their GP.

Risks include procedural risks from TEVAR, such as bleeding, artery narrowing, wound infections, heart attack, pneumonia, blood clots, and reduced blood supply leading to stroke or other issues. Serious complications are rare, but they can occur. Both CT scans and TEVAR use ionising radiation, which carries a very small increased lifetime cancer risk.

Where is the study run from?
The study is run from Imperial College London (UK).

When is the study starting and how long is it expected to run for?
September 2024 to February 2034.

Who is funding the study?
NIHR HTA Programme (UK)

Who is the main contact?
Please contact the EARNEST study team at earnest@imperial.ac.uk.

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• United Kingdom
• England
• Northern Ireland

Study participating centres

Results and Publications

Study outputs

Additional files

ISRCTN30838068_PIS_V2.3_25Feb2026.pdf

Participant information sheet

Editorial Notes

06/10/2026: The following changes were made to the study record:
1. Participant information sheet uploaded.
2. The plain English summary, inclusion and exclusion criteria were updated.
10/09/2025: The following changes were made to the trial record:
1. The date of first enrolment was changed from 01/09/2025 to 14/04/2025.
2. The ethics approval was added.
04/02/2025: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).