Treatment (Compassionate) Use of Device - PK Papyrus

NCT05436470 | Unknown

• 1 other identifier: 20220552
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pseudoaneurysm, Carotid; Pseudoaneurysm

Interventions

PK Papyrus DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• Patients from special populations including individuals who are not yet adults (infants, children, teenagers).
• Adults who are cognitively impaired, pregnant women, and prisoners.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

Jackson Memorial Hospital

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Carotid Artery Injuries; Aneurysm, False

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebrovascular Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries

Study Officials

• Robert Starke, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: June 29, 2022
• Last Updated: June 17, 2025

Record last verified: 2025-06

Locations

US (1)