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

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 of screening
• •Suspicion of bowel necrosis (as determined by the implanting physician based on imaging observations, peritoneal signs, surgical exploration, elevated serum lactate levels, 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 not expected to live 24 hours with or without operation) or class VI (a declared brain dead 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 dissection repair
• •Planned major interventional and/or open surgical procedures 30 days post the dissection repair
• •Systemic infection
• •Uncontrollable anaphylaxis to iodinated contrast (patients with allergy to iodinated contrast but not anaphylaxis may be eligible with appropriate pre-medication, as deemed 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-Dietz syndrome based on laboratory genetic testing
• •Diagnosed with acute myocardial infarction in the 30 days prior to the dissection diagnosis
• •Diagnosed with severe and catastrophic neurological complications in the 30 days prior 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 subclavian artery
• •Need for a total aortic arch replacement and/or repair, or reconstruction, of any part of the arch, and branch vessels (including extra-anatomic bypass of the branch vessels), 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 the descending aorta and measuring \>45 mm in diameter
• •Aortic arch aneurysm \>50 mm in diameter