PK Papyrus Covered Coronary Stent System

Eligibility Criteria

• * Patients with acute perforations of native coronary arteries and coronary bypass grafts in vessels 2.5 to 5.0 mm in diameter
• * 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.