PK(Pharmacokinetic) Papyrus Covered Coronary Stent System
NCT06223633 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41
Last updated 2026-06-10
Summary
The PK Papyrus Covered Coronary Stent System is a coronary stent being used at Methodist Dallas Medical Center for patients with coronary perforations.
Conditions
- Coronary Disease
Interventions
- DEVICE
-
PK Papyrus Covered Coronary Stent System
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.
Sponsors & Collaborators
-
Methodist Health System
lead OTHER
Principal Investigators
-
Luis Bowen, M.D. · The Methodist Hospital Research Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-08-10
- Primary Completion
- 2027-08-31
- Completion
- 2028-08-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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