Study to Confirm Safety and Performance of the Lifetech Cera4 Vascular Plug System for Arterial and Venous Embolization in Peripheral Blood Vessels

What this Trial Is About

This research aims to collect and assess clinical data on patients using the Lifetech Cera Vascular Plug System, a device designed for arterial and venous embolization in the peripheral vasculature. The studys purpose is to confirm the safety and performance of this device, identify any previously unknown side effects, monitor known side effects related to the device or procedures, and analyze emerging risks associated with its use. Participants will receive treatment with the Cera Vascular Plug System, which includes a self-expandable cylindrical Ni-Ti wire mesh plug and an accessory introducer kit. The study is observational and single-arm, enrolling patients who require arterial or venous embolization in the peripheral blood vessels. Each participant will be followed for approximately one year after the procedure to monitor outcomes and any device-related events. During the study, participants will undergo evaluations to measure technical success at the time of the procedure and follow-up assessments at 3, 6, and 12 months to detect clinically relevant recanalization and migration. Researchers will also monitor adverse events, serious adverse events, and device deficiencies throughout the year. The study includes various clinical visits and assessments to ensure thorough safety and performance monitoring over the total participation period of one year.

Cera™ Vascular Plug System Post-Market Clinical Follow-Up