PK Papyrus Covered Coronary Stent System

Description

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

Conditions

Coronary Disease

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Study Overview

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Study Details

Study overview

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

PK Papyrus Covered Coronary Stent System

PK Papyrus Covered Coronary Stent System

Condition
Coronary Disease
Intervention / Treatment

-

Contacts and Locations

Dallas

Methodist Dallas Medical Center, Dallas, Texas, United States, 75201

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Methodist Health System,

Luis Bowen, M.D., PRINCIPAL_INVESTIGATOR, Methodist Dallas Medical Center

Study Record Dates

2025-08