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

Acute Aortic Dissection Clinical Trial

— PERSEVERE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05174767
• Other study ID #: AMDS2101.000-C (02/21)
• Status: Recruiting
• Phase: N/A
• Start date: May 27, 2022
• Est. completion date: March 2028

Study information

• Verified date: January 2024
• Source: Artivion Inc.
• Contact: Erin Adams, BSc, MSPH
• Phone: (770) 419-3355
• Email: erin.adams[@]artivion.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 93
• Est. completion date: March 2028
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Aortic Dissection
• Aortic Dissection

Intervention

Device:
• AMDS
AMDS Implantation

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory University Medical Center	Atlanta	Georgia
United States	University of Colorado	Aurora	Colorado
United States	Ascension Seton/University of Texas	Austin	Texas
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Montefiore Einstein Medical	Bronx	New York
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Atrium Health Carolinas Medical Center	Charlotte	North Carolina
United States	Northwestern University	Chicago	Illinois
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	University of Florida	Gainesville	Florida
United States	Hartford Hospital	Hartford	Connecticut
United States	Baylor College of Medicine/ St. Luke's Medical Center	Houston	Texas
United States	University of Southern California	Los Angeles	California
United States	Yale Medical Center	New Haven	Connecticut
United States	Columbia University Irving Medical Center/New York Presbyterian Hospital	New York	New York
United States	Mount Sinai Hospital	New York	New York
United States	Northwell	New York	New York
United States	Stanford University	Palo Alto	California
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Baylor Scott & White The Heart Hospital Plano	Plano	Texas
United States	Oregon Health and Science University	Portland	Oregon
United States	Washington University in St. Louis	Saint Louis	Missouri
United States	Lankenau Medical Center	Wynnewood	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Artivion Inc.	Syneos Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Endpoint to Assess Incidence of Major Adverse Events	Patients experiencing at least one of the following MAEs: All-cause mortality (ACM); New disabling stroke; New onset renal failure requiring dialysis; Myocardial infarction (MI)	Through 30 days
Primary	Primary Endpoint to Assess Change in Maximal True Lumen (TL) diameter	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.	At 1 year