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

Recruitingn/aAges 18 Years - 85 YearsAllLifetech Scientific (Shenzhen) Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • Cera™ Vascular Plug System
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Where

9 sites
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
Adana City Hospital
Adana, Turkey (Türkiye)
Ankara University Hospital
Ankara, Turkey (Türkiye)
Bilkent City Hospital
Ankara, Turkey (Türkiye)

…and 1 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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