Follow-up on the Lifetech Cera Vascular Plug System

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to collect and evaluate clinical data on patients using the Lifetech Cera™ Vascular Plug System for arterial and venous embolization in the peripheral vasculature. The study will confirm the device's performance and safety, identify previously unknown side effects, and monitor known side effects related to the procedures or medical devices. It plans to enroll 132 subjects over a one-year period, with each participant followed for one year. The final report is expected to be completed in 2026.

Why it matters

Who can join: the full rules

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.

Where it's running

• 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

Study contacts

• Study coordinator: Rae Gong
• Email: gongrui@lifetechmed.com
• Phone: (86-755)-86026250-6957

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.