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Acute Aortic DissectionPERSEVERENCT05174767

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

A study testing AMDS in people with Acute Aortic Dissection, run by Artivion Inc. at 25 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Acute Aortic Dissection
What is being tested?
AMDS
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
115 participants
Where
25 sitesUnited States
Study dates
27 May 2022to 6 Dec 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥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)

Who cannot join

  • 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
Show all 32Show fewer
  • 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

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

United States25 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Emory University Medical Center

    Atlanta, Georgia, 30322

  • University of Colorado

    Aurora, Colorado, 80045

  • Ascension Seton/University of Texas

    Austin, Texas, 78723

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Massachusetts General Hospital

    Boston, Massachusetts, 02115

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Atrium Health Carolinas Medical Center

    Charlotte, North Carolina, 28203

  • Northwestern University

    Chicago, Illinois, 60611

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • University of Florida

    Gainesville, Florida, 32610

  • Hartford Hospital

    Hartford, Connecticut, 06102

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

    Houston, Texas, 77030

  • University of Southern California

    Los Angeles, California, 90033

  • Mount Sinai Hospital

    New York, New York, 10029

  • Columbia University Irving Medical Center/New York Presbyterian Hospital

    New York, New York, 10032

  • Northwell

    New York, New York, 10075

  • Stanford University

    Palo Alto, California, 94035

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232

  • Baylor Scott & White The Heart Hospital Plano

    Plano, Texas, 75093

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Washington University in St. Louis

    St Louis, Missouri, 63130

  • Montefiore Einstein Medical

    The Bronx, New York, 10467

  • Lankenau Medical Center

    Wynnewood, Pennsylvania, 19096

Other trials in United States

About this study

Official title: 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.

Being tested
AMDS
Keywords
Aortic Diseases, Cardiovascular Diseases, Aortic Dissection, Aortic Remodeling, Malperfusion, Acute, Acute Aortic Dissection
Medical subject headings
Aortic Diseases, Cardiovascular Diseases, Aortic Dissection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AMDSDevice

    AMDS Implantation

Study groups in NCT05174767
Study groupRoleWhat they receive
Acute DeBakey Type I DissectionExperimentalIn 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.
Receives: Device: AMDS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Through 30 days

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

    Patients experiencing Distal Anastomotic New Entry (DANE) tears

    Measured: Through 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jan 2022
  2. Study start27 May 2022
  3. Primary completion11 Dec 2023
  4. Study completion6 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Primary Cohort (n=93) and Continued Access (n=40)
Masking
None (open label)
Enrolment
115 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05174767
Sponsor's protocol ID
AMDS2101.000-C (02/21)
Acronym
PERSEVERE
Status last verified
Jan 2025
First submitted
13 Dec 2021
Last updated
15 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

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

    PubMed 39116932

  • Szeto WY, Fukuhara S, Fleischman F, Sultan I, Brinkman W, Arnaoutakis G, Takayama H, Eudailey K, Jassar A, Moon MC; PERSEVERE Investigators. One-Year Results of Novel Aortic Arch Hybrid Prosthesis for Repair of Acute DeBakey Type I Dissection With Malperfusion: PERSEVERE Study. Ann Thorac Surg. 2026 May;121(5):1069-1079. doi: 10.1016/j.athoracsur.2025.10.036. Epub 2025 Nov 12.

    PubMed 41238072

  • 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.

    PubMed 40586922

Questions about this trial

What is this clinical trial studying?

A study testing AMDS in people with Acute Aortic Dissection, run by Artivion Inc. at 25 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Endpoint to Assess Incidence of Major Adverse Events (time frame: Through 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05174767, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2025.

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