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
Lifetech Cera™ Vascular Plug System is indicated for arterial and venous embolization in the peripheral vasculature. This study, planned under the MDR requirements, aims to confirm the safety and performance of the Lifetech Cera™ Vascular Plug System, identify previously unknown side-effects, monitor the identified side-effects (related to the procedures or to the medical devices), identify and analyse emergent risks. The Study intends to enroll 132 subjects. The estimated enrollment period is 1 year, and the expected duration of each subject's participation is 1 year (i.e., the follow-up period). Final report shall be completed in 2026.
Study Type
OBSERVATIONAL
Enrollment
132
The 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.
IRCCS Ospedale San Raffaele
Milan, Italy
RECRUITINGTechnical 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.
Time frame: at procedure
Incidence of clinically relevant recanalization
Clinically relevant recanalization is defined as recanalization through the study device that requires a re-intervention.
Time frame: at 3 months, 6 months, and 12 months post-procedure
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.
Time frame: at 3 months, 6 months, and 12 months post-procedure
Incidence of device and/or procedure-related Adverse Events (AEs)
Time frame: from attempted procedure to 12 months post-procedure
Incidence of device and/or procedure-related Serious Adverse Events (SAEs)
Time frame: from attempted procedure to 12 months post-procedure
Incidence of device deficiencies
Device deficiency means any inadequacy in the identity, quality, durability, reliability, safety or performance of an investigational device, including malfunction, use errors or inadequacy in the information supplied by the manufacturer.
Time frame: from attempted procedure to 12 months post-procedure
Time to occlusion
Defined as the time from the device placement to complete occlusion of the target embolization sites.
Time frame: at procedure
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