Follow-up on the Lifetech Cera Vascular Plug System

Cera™ Vascular Plug System Post-Market Clinical Follow-Up: A Multi-center, Prospective, Observational, Single-arm, Open-label, Post-market Study

This study is looking to see how well the Lifetech Cera Vascular Plug System works and if it’s safe for people who need treatment for blood vessel issues.

Quick facts

• Study type: Observational
• Enrollment: 132 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd. (industry)
• Locations: 9 sites (Bad Hersfeld and 8 other locations)
• Trial ID: NCT06099015 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 85 who require arterial or venous embolization in the peripheral vasculature.

Not a fit: Patients who are pregnant, have known allergies to device materials, or have uncorrectable coagulopathy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the safety and efficacy of the Cera Vascular Plug System, leading to better patient outcomes in vascular procedures.

How similar studies have performed: Other studies on vascular embolization devices have shown promising results, indicating that this approach is supported by prior research.

Eligibility criteria

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.

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 this trial is running

Bad Hersfeld and 8 other locations

• Klinikum Bad Hersfeld GmbH — Bad Hersfeld, Germany (NOT_YET_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)

Study contacts

• Study coordinator: Rae Gong

Conditions: Aneurysm, Endoleak, Pulmonary Arteriovenous Malformation, Portal Hypertension, Arteriovenous Fistula, Splenic Laceration, Lifetech, Cera Vascular Plug