An expanded access record providing PK Papyrus in Pseudoaneurysm, Carotid and Pseudoaneurysm, sponsored by University of Miami. Temporarily not available at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-17.
Sponsored by University of Miami · Expanded access
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.
University of Miami is the lead sponsor of 820 studies on the registry; 161 are open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 93 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
1. Patients with traumatic, dissecting, pseudo, or other wide based aneurysms in non-perforator territories or fistulas of the extracranial or intracranial segments of the internal carotid or vertebral artery.
Exclusion Criteria:
The PK Papyrus is a balloon mounted stent that will be administered during standard of care treatment of pseudoaneurysms.
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No contact was published for this record. The registry link below has the sponsor’s details.
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Carotid Artery Injuries
University of Miami