Ceraâ„¢ Vascular Plug System Post-Market Clinical Follow-Up
Germany, Italy132 participantsStarted 2024-06-21
Plain-language summary
The objective of the study is to collect and evaluate clinical data on patients of the Lifetech Ceraâ„¢ 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
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion criteria
✓. 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;
✓. Voluntarily sign and date the Informed Consent Form (ICF) prior to any study-related activities commencement;
✓. Willing and able to comply with protocol requirements, including all study visits and procedures.
Exclusion criteria
✕. 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;
✕. 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
✕. The subject has an unresolved systemic infection;