Post-Market Celect Platinum Vena Cava Filter and Günther Tulip Retrieval Set Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 82
- 试验地点
- 7
- 主要终点
- Filter-related primary endpoint (performance)
研究概览
简要总结
This prospective, observational, post-market study will be performed to collect patient-level data on the Celect Platinum Vena Cava Filter Sets and the Günther Tulip Vena Cava Filter Retrieval Set to confirm continued safety and performance of the devices throughout their expected lifetime and continued acceptability of the benefit:risk ratio. Additionally, the study intends to evaluate longer-term (i.e., up to 5 years) outcome data while the filter is indwelling.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A patient dataset is deemed suitable for inclusion if the patient has a procedure where a Celect Platinum Vena Cava Filter is placed
- •Subject has not previously participated in the Cook MDR-2126 study.
排除标准
- •Patients will be excluded from enrollment if the patient or his/her legally authorized representative objects to collection and processing of his/her data or is not willing to sign the Informed Consent.
研究组 & 干预措施
Patients indicated for the placement of a Celect Platinum Vena Cava Filter
Patients indicated for the placement of a Celect Platinum Vena Cava Filter
干预措施: Celect Platinum Vena Cava Filter (Device)
结局指标
主要结局
Filter-related primary endpoint (performance)
时间窗: 12-months post procedure
Performance: Technical placement success and freedom from symptomatic PE while a filter is indwelling through 12 months (365 ± 30 days).These values will be reported as aggregate. Technical placement success - Deployment of filter in a location suitable to provide sufficient mechanical protection against PE with no filter deformation, fracture, premature release, or clinical migration.
Filter-related primary endpoint (safety)
时间窗: Index procedure through 12-months post procedure
Freedom from major adverse events through 12 months (365 ± 30 days), defined as clinically significant IVC penetration, migration of filter (\>2 cm)/filter components, filter fracture, embolization of filter or filter fragments to the heart or lungs, IVC thrombotic occlusion, symptomatic deep vein thrombosis while a filter is indwelling, access site complications with clinical sequelae, and procedure/device-related death.
Filter Retrieval-related primary endpoint
时间窗: At the time of retrieval procedure
Technical retrieval success, defined as endovascular retrieval of complete filter.
Filter Retrieval-related primary endpoint
时间窗: Through 30-days post procedure
Freedom from major adverse events through 30 days post-procedure, defined as access site complications with clinical sequelae, and procedure/device-related death.
次要结局
未报告次要终点