PK Papyrus Covered Coronary Stent System
1 other identifier
interventional
41
1 country
1
Brief Summary
The PK Papyrus Covered Coronary Stent System is a coronary stent being used at Methodist Dallas Medical Center for patients with coronary perforations.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 4, 2020
CompletedStudy Start
First participant enrolled
August 10, 2023
CompletedFirst Posted
Study publicly available on registry
January 25, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2025
CompletedNovember 21, 2024
January 1, 2024
2 years
November 4, 2020
November 18, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Determining the number of the unanticipated adverse events related to the use of PK Papyrus Coronary Stent Graft System
Number of patients with PK Papyrus being treated for acute perforations of native coronary arteries and bypass grafts in vessels.
Up to 10 years
Number of patients with the device
number of patients with success coronary artery and bypass grafts
10 years
Study Arms (1)
PK Papyrus Covered Coronary Stent System
EXPERIMENTALPK Papyrus Covered Coronary Stent System has been approved for use in the treatment of free perforations, defined as free contrast extravasation into the pericardium, in native coronary vessels or saphenous vein bypass grafts greater than or equal to 2.75mm in diameter.
Interventions
PK Papyrus Covered Coronary Stent System has been approved for use in the treatment of free perforations, defined as free contrast extravasation into the pericardium, in native coronary vessels or saphenous vein bypass grafts greater than or equal to 2.75mm in diameter.
Eligibility Criteria
You may qualify if:
- Patients with acute perforations of native coronary arteries and coronary bypass grafts in vessels 2.5 to 5.0 mm in diameter
You may not qualify if:
- Patients in whom antiplatelet agents or anticoagulation therapy is contraindicated.
- Patients with a known allergy or hypersensitivity to amorphous silicon carbide or any other compound of the system (siloxane-based polyurethane, L-605 cobalt chromium alloy including tungsten and nickel).
- Lesions that cannot be reached or treated with the system.
- Lesions with threatened or abrupt closure during attempted pre-dilation prior to stent implantation.
- Risk of treatment-related occlusion of vital coronary artery side branches.
- Uncorrected bleeding disorders.
- Allergy to contrast media.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Methodist Dallas Medical Center
Dallas, Texas, 75201, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Luis Bowen, M.D.
The Methodist Hospital Research Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 4, 2020
First Posted
January 25, 2024
Study Start
August 10, 2023
Primary Completion
August 1, 2025
Study Completion
August 1, 2025
Last Updated
November 21, 2024
Record last verified: 2024-01