Treatment (Compassionate) Use of Device - PK Papyrus

N/ATemporarily Not AvailableNCT05436470

University of Miami

Overview

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.

Study Type

EXPANDED_ACCESS

Conditions

Pseudoaneurysm, Carotid Pseudoaneurysm

Interventions

PK PapyrusDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Jackson Memorial Hospital

Miami, Florida, United States

Data from ClinicalTrials.gov

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