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Treatment (Compassionate) Use of Device - PK Papyrus

NCT05436470 · Status: TEMPORARILY_NOT_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2025-06-17

No results posted yet for this study

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.

Conditions

  • Pseudoaneurysm, Carotid
  • Pseudoaneurysm

Interventions

DEVICE

PK Papyrus

The PK Papyrus is a balloon mounted stent that will be administered during standard of care treatment of pseudoaneurysms.

Sponsors & Collaborators

  • University of Miami

    lead OTHER

Principal Investigators

  • Robert Starke, MD · University of Miami

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05436470 on ClinicalTrials.gov