PK Papyrus Covered Coronary Stent System

Methodist Health System

Status: Enrolling

Conditions: Coronary Disease

Treatments: Device: PK Papyrus Covered Coronary Stent System

Study type: Interventional

Funder types: Other

Identifiers

NCT06223633

078.CAR.2019.D

Details and patient eligibility

About

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

Full 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.

Enrollment: 41 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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41 participants in 1 patient group

PK Papyrus Covered Coronary Stent System

Experimental group

Description:

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.

Treatment:

Device: PK Papyrus Covered Coronary Stent System