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Recruiting NCT06223633

PK(Pharmacokinetic) Papyrus Covered Coronary Stent System

Conditions: Coronary Disease

Sex: All
Healthy volunteers: No
Phase: NA
Enrollment: 41
Sponsor: Methodist Health System

Location: Methodist Dallas Medical Center Dallas Texas

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 Criteria

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06223633). StuddyBuddy aggregates publicly available trial information.