Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-25 @ 2:45 AM
NCT ID:
NCT02816333
Eligibility Criteria:
Inclusion Criteria:
1. a) In case of acute Type B dissection (14 days from first dissection)
* Maximum aortic diameter \>40 mm or
* Increase in aortic diameter \>2 mm from baseline b) In case of subacute (15\~90 days) or chronic (90 days \~ 1 year) Type B
* Maximum aortic diameter \>55 mm or
* Increase in aortic diameter \>4 mm from baseline
2. Age 19-80 years.
3. Aorta anatomy appropriate for stent graft therapy,
1. Proximal landing zone (diameters between 23 and 42 mm) is not aneurysmal, dissected or significantly thrombosed.
2. Proximal landing zone length \>20 mm (length from the left subclavian artery origin to the primary intima tear or length from the left common carotid artery origin to the primary intima tear when the left subclavian artery is embolized and possibly revascularized), as measured from the outer curve of the aorta.
4. Declaration of voluntary participation in the study with signed informed consent form.
Exclusion Criteria:
1. Endorgan ischemia or evidence of malperfusion due to aortic dissection
2. Aortic rupture or impeding rupture due to aortic dissection
3. Renal dysfunction with serum Cr level \>2.0 mg/dL
4. Marfan syndrome, Loeys-Diets, Ehlers-Danlos syndrome, or other connective tissue diseases
5. Uncontrolled active infection or active vasculitis.
6. Recent myocardial infarction or cerebrovascular accident within 4 weeks prior to study enrollment.
7. Previous thoracic aorta surgery or stent-graft implantation
8. Planned concomitant surgical procedures (other than left subclavian artery transposition or bypass) or major surgery within 30 days of study enrolment.
9. Women with positive pregnancy test or at child bearing age
10. Life expectancy \<1 year due to comorbidity
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
79 Years
Study:
NCT02816333
Study Brief:
Protocol Section:
NCT02816333