PK Papyrus Covered Coronary Stent System

November 18, 2024 updated by: Methodist Health System
The PK Papyrus Covered Coronary Stent System is a coronary stent being used at Methodist Dallas Medical Center for patients with coronary perforations.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

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

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.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PK Papyrus Covered Coronary Stent System
PK Papyrus Covered Coronary Stent System has been approved for use in the treatment of free perforations, defined as free contrast extravasation into the pericardium, in native coronary vessels or saphenous vein bypass grafts greater than or equal to 2.75mm in diameter.
Device: PK Papyrus Covered Coronary Stent System
PK Papyrus Covered Coronary Stent System has been approved for use in the treatment of free perforations, defined as free contrast extravasation into the pericardium, in native coronary vessels or saphenous vein bypass grafts greater than or equal to 2.75mm in diameter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determining the number of the unanticipated adverse events related to the use of PK Papyrus Coronary Stent Graft System
Time Frame: Up to 10 years
Number of patients with PK Papyrus being treated for acute perforations of native coronary arteries and bypass grafts in vessels.
Up to 10 years
Number of patients with the device
Time Frame: 10 years
number of patients with success coronary artery and bypass grafts
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Methodist Health System

Investigators

  • Principal Investigator: Luis Bowen, M.D., Methodist Dallas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 10, 2023

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

November 4, 2020

First Submitted That Met QC Criteria

January 16, 2024

First Posted (Actual)

January 25, 2024

Study Record Updates

Last Update Posted (Estimated)

November 21, 2024

Last Update Submitted That Met QC Criteria

November 18, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 078.CAR.2019.D

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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