Clinical trial NCT05174767: PERSEVERE- a Trial to Evaluate AMDS in Acute DeBakey Type I Dissection
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Acute Aortic Dissection
Keywords: Aortic Diseases
Cardiovascular Diseases
Aortic Dissection
Aortic Remodeling
Malperfusion
Acute
Acute Aortic Dissection
Lead sponsor: Artivion Inc.
Sponsor class: INDUSTRY
Collaborators: name: Syneos Health
First posted: 2022-01-03
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Primary Cohort (n=93) and Continued Access (n=40)
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Primary Endpoint to Assess Incidence of Major Adverse Events
timeFrame: Through 30 days
measure: Primary Endpoint to Assess Distal Anastomotic New Entry (DANE) tears
timeFrame: Through 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Atlanta
country: United States
facility: Emory University Medical Center
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: Bronx
country: United States
facility: Montefiore Einstein Medical
state: New York
city: New York City
country: United States
facility: Northwell
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: New York
country: United States
facility: Columbia University Irving Medical Center/New York Presbyterian Hospital
state: New York
city: Charlotte
country: United States
facility: Atrium Health Carolinas Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Wynnewood
country: United States
facility: Lankenau Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Austin
country: United States
facility: Ascension Seton/University of Texas
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine/ St. Luke's Medical Center
state: Texas
city: Plano
country: United States
facility: Baylor Scott & White The Heart Hospital Plano
state: Texas
Study officials:
affiliation: University of Pennsylvania
name: Wilson Szeto, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.