Endovascular repair after aortic dissection type I or conservative – aortic remodeling enhancement (ERADICARE) trial
- Conditions
- 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.Surgery
- Registration Number
- ISRCTN11964494
- Lead Sponsor
- Evangelismos General Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 30
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.
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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Measured using the RadiAnt app at baseline, 1, 6, 12 months<br> 1. Aortic diameter.<br> 2. Diameter of true lumen.<br> 3. Diameter of false lumen.<br> 4. False lumen thrombosis.<br>
- Secondary Outcome Measures
Name Time Method