PK Papyrus Covered Coronary Stent System

Not Applicable

Recruiting

• Conditions: Coronary Disease
• Interventions: Device: PK Papyrus Covered Coronary Stent System

• Registration Number: NCT06223633
• Lead Sponsor: Methodist Health System

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-11-04
• Study Start: 2023-08-10
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-16
• Study First Posted: 2024-01-25
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-21
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 41

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PK Papyrus Covered Coronary Stent System	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Methodist Dallas Medical Center; 🇺🇸 Dallas, Texas, United States