persevere- a trial to evaluate amds in acute debakey type i dissection

Conditions: Acute Aortic Dissection

Summary: prospective, non-randomized, multicenter clinical investigation to assess the safety and effectiveness of amds in the treatment of patients with acute debakey type i dissection, with evidence of malperfusion, through open surgical repair.


Eligibility criteria:
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) and diagnosed ≤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 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

Keywords: aortic diseases cardiovascular diseases aortic dissection aortic remodeling malperfusion acute acute aortic dissection