PK Papyrus Covered Coronary Stent System

Last updated: November 18, 2024
Sponsor: Methodist Health System
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

PK Papyrus Covered Coronary Stent System

Clinical Study ID

NCT06223633
078.CAR.2019.D
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Patients in whom antiplatelet agents or anticoagulation therapy is contraindicated.

  • Patients with a known allergy or hypersensitivity to amorphous silicon carbide orany other compound of the system (siloxane-based polyurethane, L-605 cobalt chromiumalloy 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 tostent implantation.

  • Risk of treatment-related occlusion of vital coronary artery side branches.

  • Uncorrected bleeding disorders.

  • Allergy to contrast media.

Study Design

Total Participants: 41
Treatment Group(s): 1
Primary Treatment: PK Papyrus Covered Coronary Stent System
Phase:
Study Start date:
August 10, 2023
Estimated Completion Date:
August 31, 2025

Study 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.

Connect with a study center

  • Methodist Dallas Medical Center

    Dallas, Texas 75201
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.