About this trial
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
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Cera™ Vascular Plug System