JET Enhanced Thrombectomy Intervention Hong Kong Post Market Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 4
- 主要终点
- Primary Effectiveness Endpoint - For Arterial and Arteriovenous Subjects: Clot Removal Grade for Each JETi-treated Vessel
研究概览
简要总结
The JETi Hong Kong PMS is a 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 20 subjects at approximately 5 centers in Hong Kong. Subjects participating in this study will be followed for up to 30 days (in cases of prospective consent) after Day 0. Day 0 is defined as the day when the JETi catheter is introduced into the intended vasculature of the subject.
详细描述
The JETi System is a hydro-mechanical aspiration system manufactured by Abbott Medical, consisting of a catheter, pump set, and accessories. The system is intended to remove/aspirate fluid and break-up soft emboli and thrombus from the peripheral vasculature and to subselectively infuse/deliver diagnostics or therapeutics with or without vessel occlusion.
This study will collect data on how the JETi System performs in the treatment of patients undergoing a percutaneous thrombectomy procedure for peripheral thrombosis. Subjects treated for arterial, venous, or arteriovenous thromboses, and subject with diagnoses such as acute limb ischemia (ALI), chronic limb ischemia/chronic limb threatening ischemia (CLI/CTLI), peripheral artery disease (PAD), deep vein thrombosis (DVT), hemodialysis access thrombosis, and others may be included.
Both prospective and retrospective consent (if all assessments needed for the primary endpoints are complete) are permitted. After index procedure, subjects will be evaluated at discharge and 30 days in cases of prospective consent. In cases of retrospective consent, duration of participation will vary. If consent occurs after the procedure and prior to 30 days, the subject will be asked to return for a 30-day visit. If consent occurs after 30 days, the subject will not need to return for a study visit. Relevant data will be collected from the medical record.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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 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 and of Asian race.
排除标准
- •Subject has previously been registered in the JETi Hong Kong PMS 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 infectious agent within the past 20 days.
结局指标
主要结局
Primary Effectiveness Endpoint - For Arterial and Arteriovenous Subjects: Clot Removal Grade for Each JETi-treated Vessel
时间窗: During the procedure
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 (vessel basis). 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 - For Arterial and Arteriovenous Subjects: Composite of JETi-related Major Adverse Events (MAEs)
时间窗: Up to 30 days post-index procedure
JETi-related major adverse events (MAEs), defined as the following JETi-related events adjudicated by a clinical events committee (CEC) (subject basis): death, major amputation of the treated limb, or major bleeding.
Primary Effectiveness Endpoint - For Venous Subjects: Percent of Treated Vessel(s) With ≥ 75% Venous Thrombus Reduction Via Modified Marder Score (Limb Basis).
时间窗: During the procedure
Percent of treated vessel(s) with ≥ 75% venous thrombus reduction from pre-JETi venogram to final venogram (post-JETi AND after any/all adjunctive therapies to treat underlying culprit lesions) via modified Marder score (limb basis). If no adjunctive therapies or devices are used after JETi, post-JETi score is also final score.
Primary Safety Endpoint - For Venous Subjects: Composite of JETi-related Major Adverse Events (MAEs)
时间窗: Up to 30 days post-index procedure
JETi-related major adverse events (MAEs), defined as the following JETi-related events adjudicated by a clinical events committee (CEC): death, symptomatic pulmonary embolism (PE), major bleeding, or re-thrombosis of JETi-treated vessel(s).
次要结局
未报告次要终点