Status:
TEMPORARILY_NOT_AVAILABLE
Treatment (Compassionate) Use of Device - PK Papyrus
Lead Sponsor:
University of Miami
Conditions:
Pseudoaneurysm, Carotid
Pseudoaneurysm
Eligibility:
All Genders
18+ years
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.
Eligibility Criteria
Inclusion
- 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
- Patients from special populations including individuals who are not yet adults (infants, children, teenagers).
- Adults who are cognitively impaired, pregnant women, and prisoners.
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05436470
Last Update
June 17 2025
Active Locations (1)
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1
Jackson Memorial Hospital
Miami, Florida, United States, 33136