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

Running, not enrolling · Not applicable

Conditions studied: Acute Aortic Dissection

In brief

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.

Key facts

Study ID

NCT05174767

Run by

Artivion Inc.

People needed

115

Starts

2022-05-27

Expected to finish

2029-12-06

Last updated by the study team

2025-01-15

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥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)

You may not qualify if…

• 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

Where it is running

• 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 — St Louis, Missouri, 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
• Northwell — New York, New York, United States
• Montefiore Einstein Medical — The Bronx, 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

Full record on ClinicalTrials.gov

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