Treatment (Compassionate) Use of Device - PK Papyrus

TEMPORARILY_NOT_AVAILABLE

Conditions studied: Pseudoaneurysm, Carotid, Pseudoaneurysm

In brief

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 facts

Study ID

NCT05436470

Run by

University of Miami

Last updated by the study team

2026-06-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

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

Where it is running

• Jackson Memorial Hospital — Miami, Florida, United States

Full record on ClinicalTrials.gov

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