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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

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