PERSEVERE- A Trial to Evaluate AMDS in Acute DeBakey Type I Dissection
Study Phase: N/A
Recruitment Status: Recruiting
Start Date: May 27, 2022
End Date: March 01, 2028
PERSEVERE Study Team
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
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Conditions:
- Aortic Dissection