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Trial record 1 of 1 for:    NCT05174767
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PERSEVERE- A Trial to Evaluate AMDS in Acute DeBakey Type I Dissection (PERSEVERE)

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ClinicalTrials.gov Identifier: NCT05174767
Recruitment Status : Recruiting
First Posted : January 3, 2022
Last Update Posted : July 8, 2022
Sponsor:
Collaborator:
Syneos Health
Information provided by (Responsible Party):
Artivion Inc.

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.

Condition or disease Intervention/treatment Phase
Acute Aortic Dissection Device: AMDS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 93 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 27, 2022
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : March 2028

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Primary Endpoint to Assess Incidence of Major Adverse Events [ Time Frame: Through 30 days ]

    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)

  2. Primary Endpoint to Assess Change in Maximal True Lumen (TL) diameter [ Time Frame: At 1 year ]

    Patients with clinically meaningful (≥ 6.0 mm) true lumen expansion (at 1-Year), as defined by:

    Change in maximal true lumen (TL) diameter in the aortic arch at Zone 3 (2 cm distal to the origin of the left subclavian artery) from pre-operative computed tomography angiogram (CTA) measurements on admission to 1-year CTA measurements without need for device-related aortic reintervention.




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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05174767


Contacts
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Contact: Erin Adams, BSc, MSPH (770) 419-3355 erin.adams@artivion.com
Contact: PERSEVERE Study Team PERSEVERE@artivion.com

Locations
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United States, Connecticut
Hartford Hospital Recruiting
Hartford, Connecticut, United States, 06102
Contact: Alison Champagne         
Principal Investigator: Mohiuddin Cheema, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Jenna Barnes         
Principal Investigator: Arminder Jassar, MD         
United States, New York
Northwell Recruiting
New York, New York, United States, 10075
Contact: Claire Sarmiento         
Principal Investigator: Derek Brinster, MD         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Marisa Konig         
Principal Investigator: Joshua Grimm, MD         
United States, Texas
Baylor Scott & White The Heart Hospital Plano Recruiting
Plano, Texas, United States, 75093
Contact: Elyza Guerrero         
Principal Investigator: William Brinkman, MD         
Sponsors and Collaborators
Artivion Inc.
Syneos Health
Investigators
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Principal Investigator: Wilson Szeto, MD University of Pennsylvania
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Responsible Party: Artivion Inc.
ClinicalTrials.gov Identifier: NCT05174767    
Other Study ID Numbers: AMDS2101.000-C (02/21)
First Posted: January 3, 2022    Key Record Dates
Last Update Posted: July 8, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Artivion Inc.:
Aortic Diseases
Cardiovascular Diseases
Aortic Dissection
Aortic Remodeling
Malperfusion
Acute
Acute Aortic Dissection
Additional relevant MeSH terms:
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Aneurysm, Dissecting
Aneurysm
Vascular Diseases
Cardiovascular Diseases