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