PK Papyrus Covered Coronary Stent System

Coronary Disease Clinical Trial

Official title:

PK Papyrus Covered Coronary Stent System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06223633
• Other study ID #: 078.CAR.2019.D
• Status: Recruiting
• Phase: N/A
• Start date: August 10, 2023
• Est. completion date: August 2025

Study information

• Verified date: January 2024
• Source: Methodist Health System
• Contact: Colette Ngo Ndjom, M.S.
• Phone: 214-947-1279
• Email: clinicalresearch[@]mhd.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 41
• Est. completion date: August 2025
• Est. primary completion date: August 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Disease

Intervention

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.

Locations

Country	Name	City	State
United States	Methodist Dallas Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome

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