The objective of the study is to collect and evaluate clinical data on patients of the Lifetech Cera™ Vascular Plug System to:
* confirm the performance * confirm the safety * identify previously unknown side-effects * monitor the identified side-effects (related to the procedures or to the medical devices) * identify and analyse emergent risks
Aged 18 to 85;
Life expectancy > 1 year;
Require arterial or venous embolization in the peripheral vasculature;
Target embolization site(s) allow for safe insertion of the delivery catheter;
The subject is pregnant or plan to be pregnant or breast feeding;
The subject has a known allergy or hypersensitivity to any of the device materials including: nickel, stainless steel, polytetrafluoroethylene and titanium nitride;
The subject has a known allergy or hypersensitivity to contrast agent;
The subject has uncorrectable coagulopathy;
Patients who need arterial or venous embolization in the peripheral vasculature.
Cohort
Prospective
Cera™ Vascular Plug System
DeviceThe Cera™ Vascular Plug System is composed of Cera™ Vascular Plug and its accessory Introducer Kit. The Cera™ Vascular Plug is a self-expandable, cylindrical Ni-Ti wire mesh device.
Technical success
Complete occlusion of the target embolization site at the time of the procedure. A target embolization site is considered completely occluded if angiography showed no residual flow.
Incidence of clinically relevant recanalization
Clinically relevant recanalization is defined as recanalization through the study device that requires a re-intervention.
Incidence of clinically relevant migration
Clinically relevant migration is defined as migration of the study device from the target embolization site that requires a re-intervention.
Incidence of device and/or procedure-related Adverse Events (AEs)
Incidence of device and/or procedure-related Serious Adverse Events (SAEs)
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