Treatment (Compassionate) Use of Device - PK Papyrus

• Conditions: Pseudoaneurysm, Carotid; Pseudoaneurysm

• Registration Number: NCT05436470
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-21
• Study First Submitted QC: 2022-06-21
• Study First Posted: 2022-06-29
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-14
• Last Update Posted: 2024-06-18

Recruitment & Eligibility

• Status: TEMPORARILY_NOT_AVAILABLE
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified

Trial Locations

Locations (1)

Jackson Memorial Hospital; 🇺🇸 Miami, Florida, United States