PERSEVERE- a Trial to Evaluate AMDS in Acute DeBakey Type I Dissection
- Conditions
- Acute Aortic Dissection
- Interventions
- Device: AMDS
- Registration Number
- NCT05174767
- Lead Sponsor
- Artivion Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 115
- ≥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)
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Acute DeBakey Type I Dissection AMDS 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.
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (25)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
University of Southern California
🇺🇸Los Angeles, California, United States
Stanford University
🇺🇸Palo Alto, California, United States
University of Colorado
🇺🇸Aurora, Colorado, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Emory University Medical Center
🇺🇸Atlanta, Georgia, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Washington University in St. Louis
🇺🇸Saint Louis, Missouri, United States
Montefiore Einstein Medical
🇺🇸Bronx, New York, United States
Northwell
🇺🇸New York City, New York, United States
Mount Sinai Hospital
🇺🇸New York, New York, United States
Columbia University Irving Medical Center/New York Presbyterian Hospital
🇺🇸New York, New York, United States
Atrium Health Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Lankenau Medical Center
🇺🇸Wynnewood, Pennsylvania, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Ascension Seton/University of Texas
🇺🇸Austin, Texas, United States
Baylor College of Medicine/ St. Luke's Medical Center
🇺🇸Houston, Texas, United States
Baylor Scott & White The Heart Hospital Plano
🇺🇸Plano, Texas, United States