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

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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN11964494

Enrollment

Registered

2022-02-15

Start date

2022-03-01

Completion date

Unknown

Last updated

2026-03-16

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

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

Interventions

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 par

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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).

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Greece

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 20, 2026