JET Enhanced Thrombectomy Intervention Registry - JETi Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 30
- 主要终点
- Primary Effectiveness Endpoint - Clot Removal Grade From Pre-JETi to Post-JETi - Core Lab Assessed - Per Vessel Analysis
研究概览
简要总结
The JETi Registry is a prospective, single-arm, multi-center study to collect real-world data on the safety, performance, and clinical benefits of the JETi™ Hydrodynamic Thrombectomy System (JETi System) for the treatment of acute/subacute thrombosis in the peripheral vasculature. This post-market study 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
Primary Effectiveness Endpoint - Clot Removal Grade From Pre-JETi to Post-JETi - Core Lab Assessed - Per Vessel Analysis
时间窗: Baseline
Clot removal grade for each JETi-treated target vessel from pre-JETi angiogram to post-JETi angiogram (post-JETi thrombectomy and prior to any adjunctive therapies to treat underlying culprit lesions) per the grades. The independent imaging core laboratory will be responsible for assessing this endpoint. The rate of clot removal grade for each JETi-treated target vessel will be measured as per the Grades below: * Grade I: \< 50% reduction * Grade II: 50- \<95% reduction * Grade III: 95-100% reduction
Primary Safety Endpoint - Composite Rate of JETi-related MAEs
时间窗: Up to 30 days post-JETi procedure
JETi-related events defined as device-related death, major amputation of the treated limb, or major bleeding up to 30 days post-JETi procedure and as adjudicated by a clinical events committee (CEC).
次要结局
未报告次要终点