DARTS I: Feasibility, Safety, and Performance Trial

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
• •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
• •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