This is the classic website, which will be retired eventually. Please visit the modernized instead.
Working… Menu
Trial record 1 of 1 for:    PK Papyrus (Humanitarian Use Device)
Previous Study | Return to List | Next Study

Treatment (Compassionate) Use of Device - PK Papyrus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT05436470
Expanded Access Status : Temporarily not available
First Posted : June 29, 2022
Last Update Posted : June 27, 2023
Information provided by (Responsible Party):
Robert Starke, University of Miami

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

Layout table for study information
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

Intervention Details:
  • Device: PK Papyrus
    The PK Papyrus is a balloon mounted stent that will be administered during standard of care treatment of pseudoaneurysms.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All

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.

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 identifier (NCT number): NCT05436470

Layout table for location information
United States, Florida
Jackson Memorial Hospital
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Layout table for investigator information
Principal Investigator: Robert Starke, MD University of Miami
Layout table for additonal information
Responsible Party: Robert Starke, Associate Professor, University of Miami 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:
Layout table for MeSH terms
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