RECRUITING

PK Papyrus Covered Coronary Stent System

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

PK Papyrus Covered Coronary Stent System

Quick Facts

Study Start:2023-08-10
Study Completion:2025-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06223633

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.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients with acute perforations of native coronary arteries and coronary bypass grafts in vessels 2.5 to 5.0 mm in diameter
  1. * Patients in whom antiplatelet agents or anticoagulation therapy is contraindicated.
  2. * 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).
  3. * Lesions that cannot be reached or treated with the system.
  4. * Lesions with threatened or abrupt closure during attempted pre-dilation prior to stent implantation.
  5. * Risk of treatment-related occlusion of vital coronary artery side branches.
  6. * Uncorrected bleeding disorders.
  7. * Allergy to contrast media.

Contacts and Locations

Study Contact

Colette Ngo Ndjom, M.S.
CONTACT
214-947-1279
clinicalresearch@mhd.com
Zaid Haddadin, M.S.
CONTACT
214-947-1280
clinicalresearch@mhd.com

Principal Investigator

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

Study Locations (Sites)

Methodist Dallas Medical Center
Dallas, Texas, 75201
United States

Collaborators and Investigators

Sponsor: Methodist Health System

  • Luis Bowen, M.D., PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2023-08-10
Study Completion Date2025-08

Study Record Updates

Study Start Date2023-08-10
Study Completion Date2025-08

Terms related to this study

Additional Relevant MeSH Terms

  • Coronary Disease