PERSEVERE- a Trial to Evaluate AMDS in Acute DeBakey Type I Dissection
NCT05174767 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 115
Last updated 2025-01-15
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.
Conditions
- Acute Aortic Dissection
Interventions
- DEVICE
-
AMDS
AMDS Implantation
Sponsors & Collaborators
- collaborator OTHER
-
Artivion Inc.
lead INDUSTRY
Principal Investigators
-
Wilson Szeto, MD · University of Pennsylvania
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-05-27
- Primary Completion
- 2023-12-11
- Completion
- 2029-12-06
- FDA Device
- Yes
Countries
- United States
Study Locations
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