Endovascular repair after aortic dissection type I or conservative – aortic remodeling enhancement (ERADICARE) trial

ISRCTN	ISRCTN11964494
DOI	https://doi.org/10.1186/ISRCTN11964494
Secondary identifying numbers	96/31-3-2021

Submission date: 08/02/2022
Registration date: 15/02/2022
Last edited: 14/02/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
An aortic dissection is a serious condition in which a tear occurs in the inner layer of the body's main artery (aorta) and requires urgent surgery to prevent death.
The aim of this study is the investigation of the long term outcomes of the surgical technique of Transcatheter Endovascular Aortic Repair (TEVAR).

Who can participate?
Adult patients who were submitted to surgery for aortic dissection De Bakey type I restoration 1 to 6 months before re-examination.

What does the study involve?
Patients are followed up after surgery at 1, 6, and 12 months

What are the possible benefits and risks of participating?
None

Where is the study run from?
Evangelismos General Hospital (Greece)

When is the study starting and how long is it expected to run for?
February 2021 to September 2023

Who is funding the study?
National and Kapodistrian University of Athens (Greece)

Who is the main contact?
Nikolaos Schizas, nikschizas@gmail.com

Contact information

Mr Nikolaos Schizas
Scientific

Ypsilantou 45-47
Athens
10676
Greece

ORCID ID	0000-0002-3523-4881
Phone	+30 6936820715
Email	nikschizas@med.uoa.gr

Study information

Study design	Interventional randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Prevention
Participant information sheet	41110 PIS.pdf
Scientific title	Comparative study of aortic remodeling after Transcatheter Endovascular Aortic Repair (TEVAR) versus no intervention in patients previously submitted to surgery due to Aortic dissection type I.
Study acronym	ERADICARE
Study objectives	The basic hypothesis of this study is that the implementation of TEVAR in patients that were previously submitted to surgery for acute aortic dissection type I improves significantly the artic remodeling. Additionally, we estimate that the complications related to residual dissection of the aorta might be reduced. More specifically, we believe that in the intervention group the false lumen will be reduced in a greater degree in benefit of the true lumen of the aorta compared to the control group
Ethics approval(s)	Approved 31/03/2021, Bioethics Board of Evangelismos General Hospital (Ypsilantou 45-47, Athens, Greece, 10676; +30 2132041000; sseh@evaggelismos-hosp.gr), ref: 96/31-3-202
Health condition(s) or problem(s) studied	Investigation of aortic remodeling after Transcatheter Endovascular Aortic Repair (TEVAR) in patients who were previously submitted to surgery for restoration of type I aortic dissection.
Intervention	This is a comparative prospective study which is performed in “Evangelismos” General Hospital of Athens. All patients who are submitted to surgery for aortic type I dissection and are eligible for participation according to the inclusion criteria are randomized through an electronic program into two groups. The control group is constituted from all the patients in whom no further intervention was performed after the initial surgery and the intervention group, in which the patients who were submitted to TEVAR, are included. Patients of both groups are re-examined in 1-6 and 12 months through CT angiography.
Intervention type	Procedure/Surgery
Primary outcome measure	Measured using the RadiAnt app at baseline, 1, 6, 12 months 1. Aortic diameter. 2. Diameter of true lumen. 3. Diameter of false lumen. 4. False lumen thrombosis.
Secondary outcome measures	Measured using patient’s medical record, the hospital’s database at the fixed re-examination dates or when the patient’s clinical status requires. 1. Survival. 2. Need for endovascular repair in the control group (crossover) 3. Days of hospitalization. 4. The impact of anticoagulation or antiplatelet therapy in aortic remodeling. 5. Major complications including: 6. Lethal rupture. 7. Disguised aortic rupture. 8. Clinical manifestations due to aortic dissection progress as splachnic ischemia, renal dysfunction, malperfusion of legs. 9. Manifestations related to TEVAR (etc obstruction of arterial branch) 10. Renal insufficiency related to contrast administration. 11. Stroke. 12. Infections related or not related to the intervention. 13. Neurological complications as paraparesis. 14. Vascular complications related to TEVAR (etc femoral artery injury or ischemia of the leg due to peripheral vessel obstruction). 15. Any clinical manifestation that requires re-admission to hospital.
Overall study start date	01/02/2021
Completion date	01/09/2023

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	The total target number of participants is 30, 15 in each group. This number was defined after Power Analysis of the study.
Key inclusion criteria	1. Patients who were submitted to surgery for aortic dissection De Bakey type I restoration 1 to 6 months before re-examination. 2. Entry point presence in descending thoracic aorta. 3. Greatest diameter of aorta more than 40mm. 4. Greatest diameter of false diameter more than 20mm. 5. Patient’s informed consent. 6. Informed consent for TEVAR.
Key exclusion criteria	1. Findings of severe complicated aortic dissection including neurological complications, renal insufficiency or any severe complication that increases morbidity or mortality. The clinical status is estimated in the first re-examination after discharge. 2. Previous open or endovascular interventions of aorta, major branches or peripheral vessels. 3. Technically not feasible TEVAR. 4. Death within less than 30 days. 5. Intraoperative restoration of aortic arch and descending thoracic aorta (Frozen Elephant Trunk).
Date of first enrolment	01/03/2022
Date of final enrolment	01/03/2023

Locations

Countries of recruitment

Greece

Study participating centre

Evangelismos General Hospital

Ypsilantou 45-47
Athens
10676
Greece

Sponsor information

Evangelismos General Hospital
Hospital/treatment centre

Ypsilantou 45-47
Athens
10676
Greece

Phone	+30 2132041575
Email	info@evaggelismos-hosp.gr
Website	evaggelismos-hosp.gr

Funders

Funder type

University/education

National and Kapodistrian University of Athens
Government organisation / Local government

Alternative name(s): University of Athens
Location: Greece

Results and Publications

Intention to publish date	01/01/2024
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication in a high-impact peer-reviewed journal
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from nikschizas@gmail.com

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet			14/02/2022	No	Yes

Additional files

41110 PIS.pdf

Editorial Notes

14/02/2022: Trial's existence confirmed by Bioethics Board of Evangelismos General Hospital