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PK Papyrus Covered Coronary Stent System | Clinical Trials | Clareo Health

UNKNOWNNA

PK Papyrus Covered Coronary Stent System

NCT06223633•Methodist Health System

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

Age

All ages

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Methodist Dallas Medical Center

Dallas, Texas, United States

Key Dates

Start Date

August 10, 2023

Primary Completion Date

August 1, 2025

Completion Date

August 1, 2025

Last Updated

November 21, 2024

Enrollment

ESTIMATED participants

Conditions

Coronary Disease

Interventions

PK Papyrus Covered Coronary Stent System

DEVICE

Contacts

Colette Ngo Ndjom, M.S.

CONTACT

214-947-1279 clinicalresearch@mhd.com

Zaid Haddadin, M.S.

CONTACT

214-947-1280 clinicalresearch@mhd.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 21, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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PK Papyrus Covered Coronary Stent System

Inclusion Criteria

Exclusion Criteria

Postprocedural Contrast Mediated FFR Plus Intracoronary Infusion of Nitroglycerin in Multivessel Patients (PROMETEUS TRIAL)

Treatment of Functionally Non-significant Vulnerable Plaques in Patients With Multivessel ST-elevation Myocardial Infarction The VULNERABLE Trial

Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB (PICCOLETO IV-EPIC 38)

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