PERSEVERE- a Trial to Evaluate AMDS in Acute DeBakey Type I Dissection

Inclusion Criteria:

• ≥18 years of age or ≤80 years of age (male or female) at time of surgery

• Acute DeBakey type I dissection based on computed tomography angiography (CTA) anddiagnosed ≤14 days from of the index event

• Presence of malperfusion (cerebral, visceral, renal, spinal cord, and/or peripheral)

Exclusion Criteria:

• Other medical condition that is associated with limited life expectancy <2 years (e.g., cancer, congestive heart failure)

• Pregnant or breastfeeding.

• Unwilling to comply with the follow-up schedule

• Institutionalized due to administrative or judicial order

• Unwilling to accept blood transfusions for any reason

• Coronary malperfusion

• In circulatory shock (i.e., systolic blood pressure <90 mmHg) at time of screening

• In extreme hemodynamic compromise requiring cardiopulmonary resuscitation at time ofscreening

• Suspicion of bowel necrosis (as determined by the implanting physician based onimaging observations, peritoneal signs, surgical exploration, elevated serum lactatelevels, low pH, and/or acidosis)

• Clinical or radiographic signs of bowel infarction or gastrointestinal hemorrhage

• Base deficit > -10 mmol/L or -10 mEq/L

• American Society of Anesthesiologists risk class V (i.e., moribund patient notexpected to live 24 hours with or without operation) or class VI (a declared braindead patient whose organs are being removed for donor purposes)

• Previous placement of a thoracic endovascular graft

• Interventional and/or open surgical procedures 30 days prior to the dissectionrepair

• Planned major interventional and/or open surgical procedures 30 days post thedissection repair

• Systemic infection

• Uncontrollable anaphylaxis to iodinated contrast (patients with allergy to iodinatedcontrast but not anaphylaxis may be eligible with appropriate pre-medication, asdeemed suitable by the Investigator)

• Known allergy(ies) to nitinol and/or polytetrafluoroethylene

• Inability to obtain CT angiograms for follow-up

• Previously diagnosed with Marfan syndrome, Ehlers-Danlos syndrome, or Loeys-Dietzsyndrome based on laboratory genetic testing

• Diagnosed with acute myocardial infarction in the 30 days prior to the dissectiondiagnosis

• Diagnosed with severe and catastrophic neurological complications in the 30 daysprior to the dissection diagnosis (namely, obtundation or coma)

• Current Stage 5 end stage chronic kidney disease (eGFR ≤ 15 mL/min)

• History of bleeding disorder (i.e. hemophilia)

• A primary entry tear that extends into the arch or distal to the left subclavianartery

• Need for a total aortic arch replacement and/or repair, or reconstruction, of anypart of the arch, and branch vessels (including extra-anatomic bypass of the branchvessels), for any reason as deemed necessary by the Investigator

• Any pathology of mycotic origin

• Aortic fistulous communication with non-vascular structure (e.g., esophagus,bronchial)

• Extensive thrombus or calcifications in the aortic arch, as defined by CTA

• Excessive tortuosity precluding safe passage of the AMDS, as defined by CTA

• Descending thoracic aneurysm involving the proximal third (one-third) of thedescending aorta and measuring >45 mm in diameter

• Aortic arch aneurysm >50 mm in diameter