Status:
RECRUITING
Cera™ Vascular Plug System Post-Market Clinical Follow-Up
Lead Sponsor:
Lifetech Scientific (Shenzhen) Co., Ltd.
Conditions:
Aneurysm
Endoleak
Eligibility:
All Genders
18-85 years
Brief 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 unk...
Detailed Description
Lifetech Cera™ Vascular Plug System is indicated for arterial and venous embolization in the peripheral vasculature. This study, planned under the MDR requirements, aims to confirm the safety and perf...
Eligibility Criteria
Inclusion
- Aged 18 to 85;
- Life expectancy \> 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 (ICF) prior to any study-related activities commencement;
- Willing and able to comply with protocol requirements, including all study visits and procedures.
Exclusion
- The subject is pregnant or plan to be pregnant or breast feeding;
- The subject has a known allergy or hypersensitivity to any of the device materials including: nickel, stainless steel, polytetrafluoroethylene and titanium nitride;
- The subject has a known allergy or hypersensitivity to contrast agent;
- The subject has uncorrectable coagulopathy;
- 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
- The subject has an unresolved systemic infection;
- Subject who cannot tolerate general or local anesthesia;
- The subject has a connective tissue disorders (e.g. Ehlers-Danlos Syndrome), arteritis (e.g. Takayasu's Disease) or another circulatory disorder;
- The subject is participating in other drug or medical device clinical trials;
- Any condition (medical or anatomic) making the subject not suitable for transcatheter embolotherapy according to the opinion of the investigator.
Key Trial Info
Start Date :
June 21 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT06099015
Start Date
June 21 2024
End Date
June 1 2026
Last Update
September 26 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
IRCCS Ospedale San Raffaele
Milan, Italy