PK Papyrus Covered Coronary Stent System

Launched by METHODIST HEALTH SYSTEM · Jan 16, 2024

Keywords

ClinConnect Summary

The PK Papyrus Covered Coronary Stent System trial is looking at a special type of stent used to treat patients with serious heart conditions known as coronary perforations, which occur when there are tears in the heart's blood vessels. This study is currently recruiting participants at Methodist Dallas Medical Center and is open to all adults who have these perforations in their heart arteries or bypass grafts that are between 2.5 to 5.0 mm wide.

To be eligible for this trial, patients must have an acute (sudden and severe) perforation, but they cannot have certain conditions that would make the treatment unsafe, such as allergies to specific materials used in the stent or certain bleeding disorders. If you join the trial, you can expect close monitoring and care from the medical team, who will ensure that the stent is placed safely. This trial is important because it aims to improve treatment options for patients facing this critical condition.

Gender

ALL

Eligibility criteria

• 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 Officials