Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Artivion Inc.
With
Syneos Health
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
≥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)
You may not be if
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
Clareo Health | PERSEVERE- A Trial to Evaluate AMDS in Acute DeBakey Type I Dissection
