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NCT06223633

PK(Pharmacokinetic) Papyrus Covered Coronary Stent System

Recruiting
NAAll AgesInterventionalTreatment
Methodist Health System
~41 participants
Updated 2026-06-10 on ClinicalTrials.gov
What's tested:PK Papyrus Covered Coronary Stent System

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Determining the number of the unanticipated adverse events related to the use of PK Papyrus Coronary Stent Graft System
Measured over Up to 10 years
+1 more outcome measured

Conditions

Coronary Disease

Explore related trials

Coronary Artery Disease

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Luis Bowen, M.D. · PRINCIPAL_INVESTIGATOR · The Methodist Hospital Research Institute

Who to contact

Colette Ngo Ndjom, M.S.
[email protected]
214-947-1279
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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.

What this trial measures

  • Determining the number of the unanticipated adverse events related to the use of PK Papyrus Coronary Stent Graft SystemUp to 10 years

    Number of patients with PK Papyrus being treated for acute perforations of native coronary arteries and bypass grafts in vessels.

  • Number of patients with the device10 years

    number of patients with success coronary artery and bypass grafts