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


Trial ID: NCT05174767


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.

Official Title

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

Stanford Investigator(s)

Amelia Claire Watkins
Amelia Claire Watkins

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

   - 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

   - 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

   - 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,

   - 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


Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305