Actively Recruiting
Cera173 Vascular Plug System Post-Market Clinical Follow-Up: A Multi-center, Prospective, Observational, Single-arm, Open-label, Post-market Study
Led by Lifetech Scientific (Shenzhen) Co., Ltd. · Updated on 2026-05-26
132
Participants Needed
9
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the Lifetech Cera173 Vascular Plug System for patients who require arterial or venous embolization in the peripheral vasculature. This observational study aims to confirm the device's safety and performance, identify unknown side effects, monitor known side effects related to the device or procedure, and analyze emerging risks. The study plans to enroll 132 participants aged 18 to 85 years, with a life expectancy greater than one year. The study involves the use of the Cera173 Vascular Plug System, a self-expandable cylindrical Ni-Ti wire mesh device along with its accessory introducer kit. Participants will be those who need embolization treatment in peripheral arteries or veins, with target sites suitable for safe catheter insertion. This single-arm, open-label study will follow participants for one year after the procedure to monitor outcomes and safety. During the one-year follow-up, participants will undergo assessments to measure technical success at the time of the procedure and track secondary outcomes such as recanalization and migration of the device at 3, 6, and 12 months. Device- and procedure-related adverse events and serious adverse events will be monitored throughout the year. The study includes evaluations of device deficiencies and time to occlusion. Participants are expected to comply with all study visits and procedures to enable thorough safety and performance monitoring.
CONDITIONS
Brief Title
Cera™ Vascular Plug System Post-Market Clinical Follow-Up
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 85
- Life expectancy greater than 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 prior to any study-related activities
- Willing and able to comply with protocol requirements, including all study visits and procedures
You will not qualify if you...
- Pregnant or planning to be pregnant or breastfeeding
- Known allergy or hypersensitivity to device materials including nickel, stainless steel, polytetrafluoroethylene, and titanium nitride
- Known allergy or hypersensitivity to contrast agent
- Uncorrectable coagulopathy
- Planned use of anticoagulant or antiplatelet therapy that may interfere with study endpoints
- Unresolved systemic infection
- Unable to tolerate general or local anesthesia
- Connective tissue disorders, arteritis, or other circulatory disorders
- Participating in other drug or medical device clinical trials
- Any medical or anatomic condition making the subject unsuitable for transcatheter embolotherapy as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure day
Participants undergo arterial or venous embolization using the Cera™ Vascular Plug System as part of their routine care.
1 procedure visit (in-person)
Duration - 12 months
Participants are monitored for safety, device performance, and any adverse events for up to 12 months following the procedure.
Visits at 3 months, 6 months, and 12 months post-procedure
Trial Site Locations
Total: 9 locations
1
Klinikum Bad Hersfeld GmbH
Bad Hersfeld, Germany
Actively Recruiting
2
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
Actively Recruiting
3
IRCCS Ospedale San Raffaele
Milan, Italy
Actively Recruiting
4
A.O.U. Città della Salute e Della Scienza di Torino
Turin, Italy
Actively Recruiting
5
Ospedale di Circolo
Varese, Italy
Actively Recruiting
6
Adana City Hospital
Adana, Turkey (Türkiye)
Actively Recruiting
7
Ankara University Hospital
Ankara, Turkey (Türkiye)
Actively Recruiting
8
Bilkent City Hospital
Ankara, Turkey (Türkiye)
Actively Recruiting
9
Bilkent City Hospital
Ankara, Turkey (Türkiye)
Actively Recruiting
Research Team
R
Rae Gong
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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