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

Korábbi kezelés

• 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 is participating in other drug or medical device clinical trials;

Más betegség

• 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 an unresolved systemic infection;
• The subject has a connective tissue disorders (e.g. Ehlers-Danlos Syndrome), arteritis (e.g. Takayasu's Disease) or another circulatory disorder;
• Any condition (medical or anatomic) making the subject not suitable for transcatheter embolotherapy according to the opinion of the investigator.

Egyéb

• The subject is pregnant or plan to be pregnant or breast feeding;
• The subject has uncorrectable coagulopathy;
• Subject who cannot tolerate general or local anesthesia;

• 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.
• Patients for whom the doctor has decided to use the Cera Vascular Plug System, regardless of the study.