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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

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Conditions

Coronary Disease

Locations

Methodist Dallas Medical Center

Dallas, Texas 75201

United States