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Treatment (Compassionate) Use of Device - PK Papyrus | Clinical Trials | Clareo Health

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Treatment (Compassionate) Use of Device - PK Papyrus

NCT05436470•University of Miami

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Key Dates

Last Updated

June 17, 2025

Conditions

Pseudoaneurysm, CarotidPseudoaneurysm

Interventions

PK Papyrus

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Treatment (Compassionate) Use of Device - PK Papyrus

Inclusion Criteria

Exclusion Criteria

Targeting Real World Usage In Stroke Treatment

Modified Preloaded System for Renal Arteries in Fenestrated Endografting (MPSRA)

Pseudoaneurysm of the Greater Palatine Artery Following Autogenous Connective Tissue Gingival Graft : A Case Series