NCT06223633

PK Papyrus Covered Coronary Stent System

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (estimated)
• Sponsor: Methodist Health System · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-08-10
• Primary completion: 2025-08-01
• Completion: 2025-08-01
• First posted: 2024-01-25
• Last updated: 2024-11-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study