NCT06223633NARecruiting
PK(Pharmacokinetic) Papyrus Covered Coronary Stent System
Methodist Health System
Start Date
8/10/2023
Completion Date
8/1/2028
Summary
The PK Papyrus Covered Coronary Stent System is a coronary stent being used at Methodist Dallas Medical Center for patients with coronary perforations.
Detailed Description
The FDA has approved the PK Papyrus Covered Coronary Stent System for use in patients being treated for acute perforations of native coronary arteries and coronary bypass grafts in vessels ranging from 2.5 to 5.0 mm in diameter, under a Humanitarian Device Exemption (HDE #H170004). Methodist Dallas Medical Center will use this device for treating the above-described patient population.
Eligibility Criteria
Age Range: No minimum to No maximum
Inclusion Criteria:
* Patients with acute perforations of native coronary arteries and coronary bypass grafts in vessels 2.5 to 5.0 mm in diameter
Exclusion Criteria:
* 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.
Interventions
DEVICE
PK Papyrus Covered Coronary Stent System
Conditions
Coronary Disease
Locations
Methodist Dallas Medical Center
Dallas, Texas 75201
United States