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PK(Pharmacokinetic) Papyrus Covered Coronary Stent System

Recruiting

Who can join

All ages · All sexes

Full 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.

About the study

The PK Papyrus Covered Coronary Stent System is a coronary stent being used at Methodist Dallas Medical Center for patients with coronary perforations.

What is being tested

Sponsor: Methodist Health System · Participants: 41 · Started: Aug 10, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT06223633

Locations in the U.S.

TexasMethodist Dallas Medical Center, Dallas

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.