Long-Term CLinical Evaluation of Aspiration ThRombectomy Using the Symphony or ProdIgy Thrombectomy System - CLEAR-IT
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 750
- 试验地点
- 8
- 主要终点
- Peripheral Venous Cohort
研究概览
简要总结
The study is designed to evaluate the short-term and long-term clinical performance and safety of the Symphony and Prodigy thrombectomy systems used in endovascular procedures across the peripheral or pulmonary vasculature.
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 is ≥ 18 years of age
- •Subject is willing and able to comply with the follow-up schedule specified in this protocol
- •Subject is willing and able to provide written informed consent prior to any study-related data collection
- •Subject has a planned procedure, involving the use of Imperative Care vascular devices within their intended use
排除标准
- •Subjects with any contraindications per the applicable Instructions for Use
- •Subject with life expectancy of less than 1 year
- •In the opinion of the Investigator, the patient is not a suitable candidate for intervention with Imperative Care devices
- •Subject who may be unable to complete study follow-up
- •Peripheral Venous Cohort ONLY: Presence of thrombus extending more than 2 cm into the IVC on imaging
研究组 & 干预措施
Peripheral Arterial
Subjects in this cohort will undergo aspiration thrombectomy to remove thrombus from the peripheral arterial vasculature
干预措施: Prodigy Thrombectomy System (Device)
Peripheral Venous
Subjects in this cohort will undergo aspiration thrombectomy to remove thrombus from the peripheral venous vasculature
干预措施: Symphony Thrombectomy System (Device)
Pulmonary Embolism
Subjects in this cohort will undergo aspiration thrombectomy to remove thrombus from the pulmonary vasculature
干预措施: Symphony Thrombectomy System (Device)
结局指标
主要结局
Peripheral Venous Cohort
时间窗: 30 days
Treated limb improvement at 30 days, defined as no unplanned intervention for breakthrough re-thrombosis and improvement in Villalta score relative to baseline.
Pulmonary Embolism (PE) Cohort
时间窗: 30 Days
Normal right ventricular function at 30 days follow-up, defined as tricuspid annular plane systolic excursion (TAPSE) \>1.7cm , measured on transthoracic echocardiography (TTE) and independently adjudicated.
Peripheral Arterial Cohort
时间窗: 30 days
Freedom from major (above-ankle) unanticipated amputation of the index limb
次要结局
- Pulmonary Embolism Cohort(48 hours)
- Pulmonary Embolism Cohort(30 Days)
- Peripheral Venous Cohort(90)
- Peripheral Venous Cohort(180)
- Peripheral Venous Cohort(60 Days)
- Peripheral Venous Cohort(30 Days)
- Peripheral Arterial Cohort(90 Days)
- Peripheral Arterial Cohort(180 Days)
- Peripheral Arterial Cohort(30 Days)
- Peripheral Venous Cohort(Intraprocedural)
- Peripheral Venous Cohort(48 hours)
- Peripheral Venous Cohort(Hospital Discharge)
- Peripheral Venous Cohort(90 Days)
- Peripheral Venous Cohort(180 Days)
- Pulmonary Embolism Cohort(Intraprocedural)
- Pulmonary Embolism Cohort(30 days)
- Pulmonary Embolism Cohort(90 Days)
- Pulmonary Embolism Cohort(180 Days)