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:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-24 @ 11:42 PM
NCT ID:
NCT03397251
Eligibility Criteria:
Inclusion Criteria:
1. Informed Consent obtained
2. ≥18 years of age or ≤80 years of age (male or female)
Subject must have one of the following diagnosed, based on CT angiography, within 0-14 days:
3. Acute DeBakey I dissection or
4. Acute DeBakey I intramural hematoma (IMH)
Exclusion Criteria:
General Exclusion Criteria
Patients must be excluded from the study if any of the following conditions are true:
1. Less than 18 years of age or over 80 years of age
2. Life expectancy less than 2 years
3. Pregnant or breastfeeding or planning on becoming pregnant within 60 months
4. Unwilling to comply with the follow-up schedule
5. Refusal to give informed consent
6. Institutionalized individualized due to administrative or judicial order
7. Individuals with a dependent relationship to the sponsor or investigator
Medical Exclusion Criteria
Patients must be excluded from the study if any of the following conditions are true:
1. Uncontrolled systemic infection
2. Uncontrollable anaphylaxis to iodinated contrast
3. Known allergy(ies) to Nitinol and/or PTFE
4. Patient in extreme hemodynamic compromise requiring cardiopulmonary resuscitation (CPR)
5. Inability to obtain CT angiograms for follow-up
6. Previously diagnosed with Marfan syndrome, Loeys- Dietz syndrome or Ehlers- Danlos syndrome with confirmed laboratory genetic testing on a date prior to the diagnosis of the dissection
Anatomical Exclusion Criteria
1. Any pathology of mycotic origin
2. Subacute or chronic dissection of the ascending aorta and aortic arch (\>14 days after the index event)
3. Aortic fistulous communication with non-vascular structure (e.g. esophagus, bronchial)
4. Extensive thrombus or calcifications in the aortic arch as defined by CT angiography
5. Excessive tortuosity precluding safe passage of the AMDS as defined by CT angiography
6. Descending thoracic aneurysm involving the proximal third (1/3) of the descending aorta and measuring \> 45mm in diameter
7. Aortic arch aneurysm \> 45mm in diameter
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03397251
Study Brief:
Protocol Section:
NCT03397251