JET Enhanced Thrombectomy Intervention Registry - JETi Registry
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 121
- 试验地点
- 30
- 主要终点
- Composite of JETi-related major adverse events (MAEs)
研究概览
简要总结
The JETi Registry is a prospective, single-arm, multicenter study to collect real-world data on the safety, performance, and clinical benefits of the JETi System for the treatment of acute and subacute thrombosis in the peripheral vasculature. This is a post-market study that will register approximately 280 subjects at approximately 30 centers globally. Subjects participating in this registry will be followed through their 12-month follow up visit.
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
- •Subject was treated or is expected to be treated for acute/subacute thrombosis, as determined by the investigator, in the peripheral vasculature with the JETi Hydrodynamic Thrombectomy System.
- •Subject or legally authorized representative must provide written informed consent.
- •Subject must be ≥ 18 years of age.
排除标准
- •Subject has previously been registered in the JETi Registry in the last 12 months unless treated in the contralateral limb/different anatomy; patients treated in the contralateral limb/different anatomy within the last 12 months may re-enroll in the study.
- •Subject is currently participating in another drug or device clinical investigation.
- •Subject has active symptoms and/or a positive test result of COVID-19 or other rapidly spreading novel infectious agent within the past 20 days.
结局指标
主要结局
Composite of JETi-related major adverse events (MAEs)
时间窗: Up to 30 days post-index procedure
Composite of JETi-related MAEs up to 30 days post-JETi procedure, defined as the following JETi-related events adjudicated by a clinical event committee (CEC): 1. death, 2. symptomatic pulmonary embolism (PE), 3. major bleeding 4. re-thrombosis of JETi-treated vessel(s).
Percent of treated vessel(s) with ≥ 75% venous thrombus reduction via modified Marder score. The independent imaging core laboratory will be responsible for assessing this endpoint.
时间窗: Perioperative/Periprocedural
Percent of treated vessel(s) with ≥ 75% venous thrombus reduction via modified Marder from pre-JETi venogram to final venogram (post-JETi AND after any/all adjunctive therapies to treat underlying culprit lesions)
次要结局
未报告次要终点