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

Early Aortic Repair in patients Needing Endovascular/open Surgery for Type B Aortic Dissection (EARNEST): A randomised trial to assess the clinical and cost-effectiveness of thoracic endovascular aortic repair in the subacute phase after uncomplicated type B aortic dissection.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN30838068

Enrollment

470

Registered

2025-02-04

Start date

2025-04-14

Completion date

Unknown

Last updated

2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uncomplicated type B aortic dissection Surgery

Interventions

Study Design and Randomisation EARNEST is a multicentre, open-label, superiority randomised controlled trial (RCT) designed to assess the effectiveness of early intervention with Thoracic Endovascular

however, endpoint adjudication will be carried out by an independent expert panel • Study Arms 1. TEVAR + BMT + SURV Group (Intervention Arm) • Treatment: Participants undergo Thoracic Endovascular

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with uTBAD, 10 days-3 months after the day of admission with acute uTBAD to hospital (the date of the index event) 2. Age =18 years 3. Life expectancy =2 years

Exclusion criteria

Exclusion criteria: 1. Complicated TBAD (ruptured aorta, aortic dilatation >5cm or visceral/limb/spinal malperfusion, persistent pain or uncontrolled BP). 2. Previous TBAD. 3. Type A dissection 4. At significant risk from complications (either from condition related to the dissection or not – rephrase) during TEVAR

Design outcomes

Primary

Measure	Time frame
Time to first of aortic-related mortality AND/OR severe permanent neurological deficit AND/OR severe permanent cardiorespiratory failure measured using patient records throughout follow up from randomisation until the first composite event. Patients censored if there is a competing event (non-aortic-related death, patient withdrawal or end of the study). Reported when all patients are five years after randomisation	—

Measure

Time frame

Time to first of aortic-related mortality AND/OR severe permanent neurological deficit AND/OR severe permanent cardiorespiratory failure measured using patient records throughout follow up from randomisation until the first composite event. Patients censored if there is a competing event (non-aortic-related death, patient withdrawal or end of the study). Reported when all patients are five years after randomisation

—

Secondary

Measure	Time frame
1. Aortic-related mortality is measured using patient records at one year for the TEVAR group and five years after randomisation for all patients 2. All-cause mortality is measured using patient records at one year for the TEVAR group and five years after randomisation for all patients 3. Complications including stroke, paraplegia, and cardiorespiratory failure are measured using patient records throughout follow up and reported at one year for the TEVAR group and five years after randomisation for all patients 4. Reinterventions are measured using patient records throughout follow up and reported at one and five years after randomisation 5. Quality of Life (QoL) is measured using EQ-5D-5L questionnaires at baseline, 6 weeks, 6 months, 12 months, and then annually from randomisation until the end of follow up 6. Aortic remodelling is measured using CT/MRI scans assessed using a specific CT analysis protocol from the core lab at one year after TEVAR in the intervention group and at five years 7. Costs are measured using health resource use and cost data at 6 weeks, 6 months, 12 months, and then annually from randomisation and analysed at 5 years 8. Cost-effectiveness is measured using health resource use and cost data at 6 weeks, 6 months, 12 months, and then annually from randomisation and analysed at 5 years 9. Controlled blood pressure is measured using blood pressure recordings at baseline, 6 weeks, 6 months, 12 months, and then annually from randomisation until the end of follow up and analysed at 5 years	—

Measure

Time frame

1. Aortic-related mortality is measured using patient records at one year for the TEVAR group and five years after randomisation for all patients 2. All-cause mortality is measured using patient records at one year for the TEVAR group and five years after randomisation for all patients 3. Complications including stroke, paraplegia, and cardiorespiratory failure are measured using patient records throughout follow up and reported at one year for the TEVAR group and five years after randomisation for all patients 4. Reinterventions are measured using patient records throughout follow up and reported at one and five years after randomisation 5. Quality of Life (QoL) is measured using EQ-5D-5L questionnaires at baseline, 6 weeks, 6 months, 12 months, and then annually from randomisation until the end of follow up 6. Aortic remodelling is measured using CT/MRI scans assessed using a specific CT analysis protocol from the core lab at one year after TEVAR in the intervention group and at five years 7. Costs are measured using health resource use and cost data at 6 weeks, 6 months, 12 months, and then annually from randomisation and analysed at 5 years 8. Cost-effectiveness is measured using health resource use and cost data at 6 weeks, 6 months, 12 months, and then annually from randomisation and analysed at 5 years 9. Controlled blood pressure is measured using blood pressure recordings at baseline, 6 weeks, 6 months, 12 months, and then annually from randomisation until the end of follow up and analysed at 5 years

—

Countries

England, Northern Ireland, United Kingdom

Contacts

Public ContactRowan Dulson

earnest@imperial.ac.uk+44 207 594 6017

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026