Plain English Summary
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
Study website
Contact information
Type
Scientific
Contact name
Mr Nikolaos Schizas
ORCID ID
http://orcid.org/0000-0002-3523-4881
Contact details
Ypsilantou 45-47
Athens
10676
Greece
+30 6936820715
nikschizas@med.uoa.gr
Additional identifiers
EudraCT/CTIS number
Nil known
IRAS number
ClinicalTrials.gov number
Nil known
Secondary identifying numbers
96/31-3-2021
Study information
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.
Acronym
ERADICARE
Study hypothesis
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
Study design
Interventional randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Prevention
Patient information sheet
See additional files (in Greek)
Condition
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
Overall study end date
01/09/2023
Reason abandoned (if study stopped)
Eligibility
Participant 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.
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.
Participant 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).
Recruitment start date
01/03/2022
Recruitment end date
01/03/2023
Locations
Countries of recruitment
Greece
Study participating centre
Evangelismos General Hospital
Ypsilantou 45-47
Athens
10676
Greece
Sponsor information
Organisation
Evangelismos General Hospital
Sponsor details
Ypsilantou 45-47
Athens
10676
Greece
+30 2132041575
info@evaggelismos-hosp.gr
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
University/education
Funder name
National and Kapodistrian University of Athens
Alternative name(s)
University of Athens
Funding Body Type
government organisation
Funding Body Subtype
Local government
Location
Greece
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal
Intention to publish date
01/01/2024
Individual participant data (IPD) Intention to share
Yes
IPD sharing plan
The datasets generated during and/or analysed during the current study are/will be available upon request from nikschizas@gmail.com
IPD sharing plan summary
Available on request
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 14/02/2022 | No | Yes |