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Treatment (Compassionate) Use of Device - PK Papyrus

Treatment (Compassionate) Use of Device - PK Papyrus

Status
TEMPORARILY_NOT_AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT05436470
Enrollment
Unknown
Registered
2022-06-29
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pseudoaneurysm, Pseudoaneurysm, Carotid

Brief 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.

Interventions

DEVICEPK Papyrus

The PK Papyrus is a balloon mounted stent that will be administered during standard of care treatment of pseudoaneurysms.

Sponsors

University of Miami
Lead SponsorOTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

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

1. Patients from special populations including individuals who are not yet adults (infants, children, teenagers). 2. Adults who are cognitively impaired, pregnant women, and prisoners.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORRobert Starke, MD

University of Miami

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 18, 2026