The purpose of this study is to evaluate the clinical use of the PK Papyrus CoronaryStent Graft System, a Humanitarian Use Device (HUD) approved by the FDA under aHumanitarian Device Exemption.
Not Provided
Device: PK Papyrus
The PK Papyrus is a balloon mounted stent that will be administered during standard of
care treatment of pseudoaneurysms.
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.
Jackson Memorial Hospital
Miami, Florida, United States
Robert Starke, MD, Principal Investigator
University of Miami