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

Artivion Inc.25 sites in 1 country115 target enrollmentMay 27, 2022

ConditionsAcute Aortic Dissection

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Acute Aortic Dissection
Sponsor: Artivion Inc.
Enrollment: 115
Locations: 25
Primary Endpoint: Primary Endpoint to Assess Incidence of Major Adverse Events
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 27, 2022

End Date

December 6, 2029

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Artivion Inc.

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

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)

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

Time Frame: Through 30 days

Patients experiencing Distal Anastomotic New Entry (DANE) tears