Treatment (Compassionate) Use of Device - PK Papyrus

NCT ID: NCT05436470

Last Updated: 2025-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TEMPORARILY_NOT_AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

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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

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Conditions

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Pseudoaneurysm, Carotid Pseudoaneurysm

Interventions

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PK Papyrus

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Robert Starke

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert Starke, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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Jackson Memorial Hospital

Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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20220552

Identifier Type: -

Identifier Source: org_study_id

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