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

NCT05174767 | Active Not Recruiting DMC FDA Device

• 1 other identifier: AMDS2101.000-C (02/21)
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 25

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

Keywords

Aortic Diseases; Cardiovascular Diseases; Aortic Dissection; Aortic Remodeling; Malperfusion; Acute; Acute Aortic Dissection

Outcome Measures

Primary Outcomes (2)

• Primary Endpoint to Assess Incidence of Major Adverse Events

  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)

  Through 30 days

• Primary Endpoint to Assess Distal Anastomotic New Entry (DANE) tears

  Patients experiencing Distal Anastomotic New Entry (DANE) tears

  Through 30 days

Study Arms (1)

Acute DeBakey Type I Dissection

EXPERIMENTAL

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

Interventions

AMDS DEVICE

AMDS Implantation

Acute DeBakey Type I Dissection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Artivion Inc.: lead
• Syneos Health: collaborator

Study Sites (25)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

Stanford University

Palo Alto, California, 94035, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

Emory University Medical Center

Atlanta, Georgia, 30322, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63130, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Columbia University Irving Medical Center/New York Presbyterian Hospital

New York, New York, 10032, United States

Location

Northwell

New York, New York, 10075, United States

Location

Montefiore Einstein Medical

The Bronx, New York, 10467, United States

Location

Atrium Health Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Lankenau Medical Center

Wynnewood, Pennsylvania, 19096, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Ascension Seton/University of Texas

Austin, Texas, 78723, United States

Location

Baylor College of Medicine/ St. Luke's Medical Center

Houston, Texas, 77030, United States

Location

Baylor Scott & White The Heart Hospital Plano

Plano, Texas, 75093, United States

Location

Related Publications (2)

• 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.

  PMID: 39116932 BACKGROUND

• 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.

  PMID: 40586922 DERIVED

MeSH Terms

Conditions

Aortic Diseases; Cardiovascular Diseases; Aortic Dissection

Condition Hierarchy (Ancestors)

Vascular Diseases; Dissection, Blood Vessel; Aneurysm; Acute Aortic Syndrome

Study Officials

• Wilson Szeto, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Primary Cohort (n=93) and Continued Access (n=40)

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: January 3, 2022
• Study Start: May 27, 2022
• Primary Completion: December 11, 2023
• Study Completion (Estimated): December 6, 2029
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (25)