RecruitingNot ApplicableNCT06223633
PK(Pharmacokinetic) Papyrus Covered Coronary Stent System
Sponsor
Methodist Health System
Enrollment
41 participants
Start Date
Aug 10, 2023
Study Type
INTERVENTIONAL
Conditions
Summary
The PK Papyrus Covered Coronary Stent System is a coronary stent being used at Methodist Dallas Medical Center for patients with coronary perforations.
Eligibility
Inclusion Criteria1
- Patients with acute perforations of native coronary arteries and coronary bypass grafts in vessels 2.5 to 5.0 mm in diameter
Exclusion Criteria7
- 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.
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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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06223633
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