DARTS I: Feasibility, Safety, and Performance Trial

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 7

Inclusion 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

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with treatment-related mortality;Number of participants with treatment-related neurological deficit;Number of patients with aortic injury associated with the implantation of the device;Aortic arch branch vessel patency

Secondary Outcome Measures

Name	Time	Method
Number of participants with treatment-related mortality;Number of participants with treatment-related neurological deficit;Number of patients with aortic injury associated with the implantation of the device;Aortic arch branch vessel patency