Coronary Disease
Conditions
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.
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.
Interventions
DEVICEPK 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
Methodist Health System
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determining the number of the unanticipated adverse events related to the use of PK Papyrus Coronary Stent Graft System | Up to 10 years | Number of patients with PK Papyrus being treated for acute perforations of native coronary arteries and bypass grafts in vessels. |
| Number of patients with the device | 10 years | number of patients with success coronary artery and bypass grafts |
Countries
United States
Contacts
CONTACTColette Ngo Ndjom, M.S.
CONTACTZaid Haddadin, M.S.
PRINCIPAL_INVESTIGATORLuis Bowen, M.D.
The Methodist Hospital Research Institute
Outcome results
None listed