Cera™ Vascular Plug System: The Cera™ Vascular Plug System is composed of Cera™ Vascular Plug and its accessory Introducer Kit. The Cera™ Vascular Plug is a self-expandable, cylindrical Ni-Ti wire mesh device.
Study 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
Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
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.
7. Patients for whom the doctor has decided to use the Cera Vascular Plug System, regardless of the study.
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.
Primary outcome measure(s)
Technical success — at procedure Complete occlusion of the target embolization site at the time of the procedure. A target embolization site is considered completely occluded if angiography showed no residual flow.
Trial sites (9)
Facility
City
Region
Status
Klinikum Bad Hersfeld GmbH
Bad Hersfeld
Germany
Recruiting
ASST Grande Ospedale Metropolitano Niguarda
Milan
Italy
Recruiting
IRCCS Ospedale San Raffaele
Milan
Italy
Recruiting
A.O.U. Città della Salute e Della Scienza di Torino
Turin
Italy
Recruiting
Ospedale di Circolo
Varese
Italy
Recruiting
Adana City Hospital
Adana
Turkey (Türkiye)
Recruiting
Ankara University Hospital
Ankara
Turkey (Türkiye)
Recruiting
Bilkent City Hospital
Ankara
Turkey (Türkiye)
Recruiting
Bilkent City Hospital
Ankara
Turkey (Türkiye)
Recruiting
More Lifetech Scientific (Shenzhen) Co., Ltd. trials in Turkey
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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