Cera™ Vascular Plug System Post-Market Clinical Follow-Up: A Multi-center, Prospective, Observational, Single-arm, Open-label, Post-market Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 132
- 试验地点
- 8
- 主要终点
- Technical success
研究概览
简要总结
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
详细描述
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 performance of the Lifetech Cera™ Vascular Plug System, identify previously unknown side-effects, monitor the identified side-effects (related to the procedures or to the medical devices), identify and analyse emergent risks. The Study intends to enroll 132 subjects. The estimated enrollment period is 1 year, and the expected duration of each subject's participation is 1 year (i.e., the follow-up period). Final report shall be completed in 2026.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Patients for whom the doctor has decided to use the Cera Vascular Plug System, regardless of the study.
排除标准
- •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.
研究组 & 干预措施
Cera Vascular Plug Subjects
Patients who need arterial or venous embolization in the peripheral vasculature.
干预措施: Cera™ Vascular Plug System (Device)
结局指标
主要结局
Technical success
时间窗: at procedure
Complete occlusion of the target embolization site at the time of the procedure. A target embolization site is considered completely occluded if angiography showed no residual flow.
次要结局
- Incidence of clinically relevant migration(at 3 months, 6 months, and 12 months post-procedure)
- Incidence of device and/or procedure-related Serious Adverse Events (SAEs)(from attempted procedure to 12 months post-procedure)
- Incidence of device and/or procedure-related Adverse Events (AEs)(from attempted procedure to 12 months post-procedure)
- Time to occlusion(at procedure)
- Incidence of clinically relevant recanalization(at 3 months, 6 months, and 12 months post-procedure)
- Incidence of device deficiencies(from attempted procedure to 12 months post-procedure)