PERSEVERE- a Trial to Evaluate AMDS in Acute DeBakey Type I Dissection (PERSEVERE)

A ProspEctive, Single ARm, Multi-center Clinical InveStigation to EValuatE the Safety and Effectiveness of AMDS in the TREatment of Acute DeBakey Type I Dissection: PERSEVERE

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Acute Aortic Dissection
• Intervention / Treatment: Device: AMDS

• Study Type: Interventional
• Enrollment (Actual): 115
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
  • California
    • Los Angeles, California, United States, 90033
      • University of Southern California
    • Palo Alto, California, United States, 94035
      • Stanford University
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • Hartford Hospital
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Massachusetts General Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • Missouri
    • Saint Louis, Missouri, United States, 63130
      • Washington University in St. Louis
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Einstein Medical
    • New York, New York, United States, 10029
      • Mount Sinai Hospital
    • New York, New York, United States, 10032
      • Columbia University Irving Medical Center/New York Presbyterian Hospital
    • New York City, New York, United States, 10075
      • Northwell
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Atrium Health Carolinas Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • University of Pittsburgh Medical Center
    • Wynnewood, Pennsylvania, United States, 19096
      • Lankenau Medical Center
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Texas
    • Austin, Texas, United States, 78723
      • Ascension Seton/University of Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine/ St. Luke's Medical Center
    • Plano, Texas, United States, 75093
      • Baylor Scott & White The Heart Hospital Plano

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

Device: AMDS; AMDS Implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Endpoint to Assess Incidence of Major Adverse Events	Patients experiencing at least one of the following MAEs: All-cause mortality (ACM); New disabling stroke; New onset renal failure requiring dialysis; Myocardial infarction (MI)	Through 30 days
Primary Endpoint to Assess Distal Anastomotic New Entry (DANE) tears	Patients experiencing Distal Anastomotic New Entry (DANE) tears	Through 30 days

Collaborators and Investigators

• Sponsor: Artivion Inc.
• Collaborators: Syneos Health
• Investigators: Principal Investigator: Wilson Szeto, MD, University of Pennsylvania

Publications and helpful links

General Publications

• Szeto WY, Fukuhara S, Fleischman F, Sultan I, Brinkman W, Arnaoutakis G, Takayama H, Eudailey K, Brinster D, Jassar A, DeRose J, Brown C, Farrington W, Moon MC. A novel hybrid prosthesis for open repair of acute DeBakey type I dissection with malperfusion: Early results from the PERSEVERE trial. J Thorac Cardiovasc Surg. 2024 Aug 6:S0022-5223(24)00677-9. doi: 10.1016/j.jtcvs.2024.07.059. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2022
• Primary Completion (Actual): December 11, 2023
• Study Completion (Estimated): December 6, 2029

Study Registration Dates

• First Submitted: December 13, 2021
• First Submitted That Met QC Criteria: December 13, 2021
• First Posted (Actual): January 3, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 13, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Cardiovascular Diseases; Malperfusion; Acute; Aortic Dissection; Aortic Diseases; Aortic Remodeling; Acute Aortic Dissection
• Additional Relevant MeSH Terms: Dissection, Blood Vessel; Acute Aortic Syndrome; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aneurysm; Aortic Dissection
• Other Study ID Numbers: AMDS2101.000-C (02/21)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No