Back to resultsTreatment (Compassionate) Use of Device - PK Papyrus
Primary Purpose
Pseudoaneurysm, Carotid, Pseudoaneurysm
Status
Temporarily not available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
PK Papyrus
Sponsored by
About this trial
This is an expanded access trial for Pseudoaneurysm, Carotid
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:
- Patients from special populations including individuals who are not yet adults (infants, children, teenagers).
- Adults who are cognitively impaired, pregnant women, and prisoners.
Sites / Locations
- Jackson Memorial Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05436470
Brief Title
Treatment (Compassionate) Use of Device - PK Papyrus
Official Title
Treatment (Compassionate) Use of Device - PK Papyrus
Study Type
Expanded Access
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Temporarily not available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pseudoaneurysm, Carotid, Pseudoaneurysm
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
PK Papyrus
Intervention Description
The PK Papyrus is a balloon mounted stent that will be administered during standard of care treatment of pseudoaneurysms.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
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:
Patients from special populations including individuals who are not yet adults (infants, children, teenagers).
Adults who are cognitively impaired, pregnant women, and prisoners.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Starke, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jackson Memorial Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Treatment (Compassionate) Use of Device - PK Papyrus
We'll reach out to this number within 24 hrs