Acute Aortic Dissection
Conditions
Keywords
Aortic Diseases, Cardiovascular Diseases, Aortic Dissection, Aortic Remodeling, Malperfusion, Acute, Acute Aortic Dissection
Brief 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.
Interventions
DEVICEAMDS
AMDS Implantation
Sponsors
Syneos Health
Artivion Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Primary Cohort (n=93) and Continued Access (n=40)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Endpoint to Assess Incidence of Major Adverse Events | Through 30 days | Patients experiencing at least one of the following MAEs: 1. All-cause mortality (ACM) 2. New disabling stroke 3. New onset renal failure requiring dialysis 4. Myocardial infarction (MI) |
| Primary Endpoint to Assess Distal Anastomotic New Entry (DANE) tears | Through 30 days | Patients experiencing Distal Anastomotic New Entry (DANE) tears |
Countries
United States
Outcome results
None listed