The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov 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.
 
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

Tracking Information
First Submitted Date June 21, 2022
First Posted Date June 29, 2022
Last Update Posted Date June 27, 2023
 
Descriptive Information
Brief Title Treatment (Compassionate) Use of Device - PK Papyrus
Official Title Treatment (Compassionate) Use of Device - PK Papyrus
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.
Detailed Description Not Provided
Study Type Expanded Access
Expanded Access Type Individual Patients
Condition
  • Pseudoaneurysm, Carotid
  • Pseudoaneurysm
Intervention Device: PK Papyrus
The PK Papyrus is a balloon mounted stent that will be administered during standard of care treatment of pseudoaneurysms.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status Temporarily not available
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT05436470
Other Study ID Numbers 20220552
Current Responsible Party Robert Starke, University of Miami
Original Responsible Party Same as current
Current Study Sponsor University of Miami
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Robert Starke, MD University of Miami
PRS Account University of Miami
Verification Date June 2023