Endovascular repair after aortic dissection type I or conservative – aortic remodeling enhancement (ERADICARE) trial
| ISRCTN | ISRCTN11964494 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11964494 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 96/31-3-2021 |
| Sponsor | Evangelismos General Hospital |
| Funder | National and Kapodistrian University of Athens |
- 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
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
Scientific
Ypsilantou 45-47
Athens
10676
Greece
 ORCID ID |
0000-0002-3523-4881 |
|---|---|
| Phone | +30 6936820715 |
| nikschizas@med.uoa.gr |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Measured using the RadiAnt app at baseline, 1, 6, 12 months |
| Key secondary outcome measure(s) |
Measured using patient’s medical record, the hospital’s database at the fixed re-examination dates or when the patient’s clinical status requires. |
| Completion date | 01/09/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 30 |
| 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
Athens
10676
Greece
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| 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 | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- 41110 PIS.pdf
- Participant information sheet
Editorial Notes
14/02/2022: Trial's existence confirmed by Bioethics Board of Evangelismos General Hospital
