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Trial record 1 of 1 for:    PK Papyrus (Humanitarian Use Device)
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Treatment (Compassionate) Use of Device - PK Papyrus

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ClinicalTrials.gov Identifier: NCT05436470
Expanded Access Status : Temporarily not available
First Posted : June 29, 2022
Last Update Posted : June 27, 2023
Sponsor:
Information provided by (Responsible Party):
Robert Starke, University of Miami

Study Description
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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.

Condition or disease Intervention/treatment
Pseudoaneurysm, Carotid Pseudoaneurysm Device: PK Papyrus

Study Design
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Study Type : Expanded Access
Expanded Access Type : Individual Patients
Official Title: Treatment (Compassionate) Use of Device - PK Papyrus

Resource links provided by the National Library of Medicine


Interventions
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Intervention Details:
  • Device: PK Papyrus
    The PK Papyrus is a balloon mounted stent that will be administered during standard of care treatment of pseudoaneurysms.
Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05436470


Locations
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United States, Florida
Jackson Memorial Hospital
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Investigators
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Principal Investigator: Robert Starke, MD University of Miami
More Information
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Responsible Party: Robert Starke, Associate Professor, University of Miami
ClinicalTrials.gov Identifier: NCT05436470    
Other Study ID Numbers: 20220552
First Posted: June 29, 2022    Key Record Dates
Last Update Posted: June 27, 2023
Last Verified: June 2023
Additional relevant MeSH terms:
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Carotid Artery Injuries
Aneurysm, False
Vascular Diseases
Cardiovascular Diseases
Carotid Artery Diseases
Cerebrovascular Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Cerebrovascular Trauma
Trauma, Nervous System
Wounds and Injuries