Cera™ Vascular Plug System Post-Market Clinical Follow-Up
Trial Parameters
Brief Summary
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
Inclusion Criteria: 1. Aged 18 to 85; 2. Life expectancy \> 1 year; 3. Require arterial or venous embolization in the peripheral vasculature; 4. Target embolization site(s) allow for safe insertion of the delivery catheter; 5. Voluntarily sign and date the Informed Consent Form (ICF) prior to any study-related activities commencement; 6. Willing and able to comply with protocol requirements, including all study visits and procedures. Exclusion Criteria: 1. The subject is pregnant or plan to be pregnant or breast feeding; 2. The subject has a known allergy or hypersensitivity to any of the device materials including: nickel, stainless steel, polytetrafluoroethylene and titanium nitride; 3. The subject has a known allergy or hypersensitivity to contrast agent; 4. The subject has uncorrectable coagulopathy; 5. The subject has planned use of anticoagulant (e.g. direct thrombin inhibitors, factor Xa inhibitors, vitamin K antagonists) or antiplatelet therapy before, during and/or after treat