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

ID#: NCT05174767

Age: 18 - 80 years

Gender: All

Healthy Subjects: No

Study Phase: N/A

Recruitment Status: Recruiting

Start Date: May 27, 2022

End Date: March 01, 2028

Contact Information:
Erin Adams, BSc, MSPH
(770) 419-3355
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.

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