DARTS I Feasibility Study

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 40

Inclusion Criteria

Inclusion Criteria: Subject must have one of the following diagnosed, based on CT angiography, within 0-14 days: 1. Acute DeBakey type I dissection or 2. Acute DeBakey type 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 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.

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with device-related mortality;Number of participants with device-related mortality;Number of participants with device-related mortality;Number of participants with neurological complications (TIA, stroke);Number of participants with neurological complications (TIA, stroke);Number of participants with neurological complications (TIA, stroke)

Secondary Outcome Measures

Name	Time	Method
Thrombosis of the false lumen within the confines of the device;Assess need for stent removal;Successful reattachment of the intimal flap within the arch;Successful device deployment, and radiographic evidence of false lumen exclusion within the confines of the device