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

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

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 treatment with the study device, which, in the opinion of the Investigator, would clinically interfere with the study endpoints
6. The subject has an unresolved systemic infection;
7. Subject who cannot tolerate general or local anesthesia;
8. The subject has a connective tissue disorders (e.g. Ehlers-Danlos Syndrome), arteritis (e.g. Takayasu's Disease) or another circulatory disorder;
9. The subject is participating in other drug or medical device clinical trials;
10. Any condition (medical or anatomic) making the subject not suitable for transcatheter embolotherapy according to the opinion of the investigator.

Conditions7

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