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Temporarily Not Available
NCT05436470
Treatment (Compassionate) Use of Device - PK Papyrus
Conditions: Pseudoaneurysm, Carotid, Pseudoaneurysm
Sex: All
Ages: 18 Years – N/A
Sponsor: University of Miami
Location: Jackson Memorial Hospital Miami Florida
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT05436470). StuddyBuddy aggregates publicly available trial information.