DARTS I: Feasibility, Safety, and Performance Trial

AMDS is designed to complement the replacement of the ascending aorta with conventional surgical technique utilizing a conventional polyester graft. AMDS is constructed of an uncovered Nitinol wire braided stent attached proximally to a polytetrafluoroethylene (PTFE) felt graft component. The PFTE felt graft component excludes the FL at the distal aortic anastomosis and the wire stent re-expands the dissection flap within the arch and descending aorta, which aims to treat malperfusion and promote positive remodeling of the aorta.

The DARTS I Feasibility, Safety and Performance trial is a prospective, non-randomized, non-blinded, single-arm, multi-institutional Canadian study evaluating the feasibility and safety of the AMDS graft. A goal of 30 subjects will be enrolled at 1 site in Germany.

The enrollment period will span a minimum of 3 months from Institutional Review Board (IRB) approval and site activation. Candidates for this study are adults who require repair of an acute DeBakey type I aorta dissection and/or intramural hematoma (IMH). Patients will be consented pre-operatively and enrolled patients will be followed for approximately 5 years after their AMDS implantation date. Data will be collected at 10 time points: baseline (pre-operatively), discharge, 1 month post-operatively, 3 months post-operatively, and 6 months post-operatively, 1 year post-operatively and thereafter, annually, for a total of 5 years.

Inclusion criteria

• Informed Consent obtained
• ≥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:

• Acute DeBakey I dissection or
• 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:

• Less than 18 years of age or over 80 years of age
• Life expectancy less than 2 years
• Pregnant or breastfeeding or planning on becoming pregnant within 60 months
• Unwilling to comply with the follow-up schedule
• Refusal to give informed consent
• Institutionalized individualized due to administrative or judicial order
• 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:

• Uncontrolled systemic infection
• Uncontrollable anaphylaxis to iodinated contrast
• Known allergy(ies) to Nitinol and/or PTFE
• Patient in extreme hemodynamic compromise requiring cardiopulmonary resuscitation (CPR)
• Inability to obtain CT angiograms for follow-up
• 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

• Any pathology of mycotic origin
• Subacute or chronic dissection of the ascending aorta and aortic arch (>14 days after the index event)
• Aortic fistulous communication with non-vascular structure (e.g. esophagus, bronchial)
• Extensive thrombus or calcifications in the aortic arch as defined by CT angiography
• Excessive tortuosity precluding safe passage of the AMDS as defined by CT angiography
• Descending thoracic aneurysm involving the proximal third (1/3) of the descending aorta and measuring > 45mm in diameter
• Aortic arch aneurysm > 45mm in diameter