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UNKNOWN
NCT05436470
Treatment (Compassionate) Use of Device - PK Papyrus
Sponsor: University of Miami
View on ClinicalTrials.gov
Summary
The purpose of this study is to evaluate the clinical use of the PK Papyrus Coronary Stent Graft System, a Humanitarian Use Device (HUD) approved by the FDA under a Humanitarian Device Exemption.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
EXPANDED_ACCESS
Enrollment
Not specified
Start Date
Not specified
Completion Date
Not specified
Last Updated
2026-06-17
Healthy Volunteers
Not specified
Conditions
Interventions
DEVICE
PK Papyrus
The PK Papyrus is a balloon mounted stent that will be administered during standard of care treatment of pseudoaneurysms.
Locations (1)
Jackson Memorial Hospital
Miami, Florida, United States