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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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05436470). StuddyBuddy aggregates publicly available trial information.