Cera™ Vascular Plug System Post-Market Clinical Follow-Up
Recruiting · NCT06099015 · Observational (researchers observe without assigning treatment) · Lead sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
Cera™ Vascular Plug System
What this trial is about
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
Who can take part
Age range
18 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
- Patients for whom the doctor has decided to use the Cera Vascular Plug System, regardless of the study.
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;
- Subject who cannot tolerate general or local anesthesia;
- The subject has a connective tissue disorders (e.g. Ehlers-Danlos Syndrome), arteritis (e.g. Takayasu's Disease) or another circulatory disorder;
- The subject is participating in other drug or medical device clinical trials;
- Any condition (medical or anatomic) making the subject not suitable for transcatheter embolotherapy according to the opinion of the investigator.
Where it is running
9 locations listed.
- Adana City Hospital - Adana, Turkey (Türkiye)
- Ankara University Hospital - Ankara, Turkey (Türkiye)
- Bilkent City Hospital - Ankara, Turkey (Türkiye)
- Bilkent City Hospital - Ankara, Turkey (Türkiye)
- Klinikum Bad Hersfeld GmbH - Bad Hersfeld, Germany
- ASST Grande Ospedale Metropolitano Niguarda - Milan, Italy
- IRCCS Ospedale San Raffaele - Milan, Italy
- A.O.U. Città della Salute e Della Scienza di Torino - Turin, Italy
- Ospedale di Circolo - Varese, Italy