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Recruiting
Trial ID: NCT05174767
A ProspEctive, Single ARm, Multi-center Clinical InveStigation to EValuatE the Safety and Effectiveness of AMDS in the TREatment of Acute DeBakey Type I Dissection: PERSEVERE
Clinical Assistant Professor, Cardiothoracic Surgery
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
device: AMDS
Recruiting
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305