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

NCT ID: NCT05174767

Last Updated: 2025-01-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-27
• Study Completion Date: 2029-12-06

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.

Conditions

Acute Aortic Dissection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

AMDS

Intervention Type: DEVICE

AMDS Implantation

Interventions

AMDS

AMDS Implantation

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Syneos Health

OTHER

Sponsor Role: collaborator

Artivion Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wilson Szeto, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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

Countries

United States

References

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. 2025 Jul;170(1):114-123.e3. doi: 10.1016/j.jtcvs.2024.07.059. Epub 2024 Aug 6.

Reference Type: BACKGROUND

PMID: 39116932 (View on PubMed)

Brinkman W, Squiers JJ, Jassar A, Fukuhara S, Fleischman F, Takayama H, Sultan I, Arnaoutakis G, Moon MC, Szeto WY; PERSEVERE Investigators. Cerebral malperfusion resolution after repair of acute DeBakey type I dissection with a novel hybrid prosthesis: early results of the PERSEVERE Studydagger. Eur J Cardiothorac Surg. 2025 Jul 1;67(7):ezaf199. doi: 10.1093/ejcts/ezaf199.

Reference Type: DERIVED

PMID: 40586922 (View on PubMed)

Other Identifiers

AMDS2101.000-C (02/21)

Identifier Type: -

Identifier Source: org_study_id