PERSEVERE- A Trial to Evaluate AMDS in Acute DeBakey Type I Dissection
Purpose
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.
Condition
- Acute Aortic Dissection
Eligibility
- Eligible Ages
- Between 18 Years and 80 Years
- Eligible Genders
- All
- Accepts 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- Primary Cohort (n=93) and Continued Access (n=40)
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Acute DeBakey Type I Dissection |
In eligible patients, the ascending aorta is transected and removed in a routine standard of care manner utilizing hypothermic circulatory arrest; the operator will leave at least 10 mm (1.0 cm) aortic tissue proximal to the innominate artery. AMDS is pre-loaded onto the delivery system and is delivered into the true lumen through the open distal aorta and implanted according to the instructions for use. |
|
Recruiting Locations
University of Alabama at Birmingham
Birmingham, Alabama 35294
Birmingham, Alabama 35294
Contact:
Dorothy Neithers
Dorothy Neithers
More Details
- Status
- Recruiting
- Sponsor
- Artivion Inc.