CHOMP: SurmodiCs Pounce Venous THrOMbectomy System Post Market Clinical Follow Up Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Device Performance
研究概览
简要总结
This is an open label, prospective, non-randomised, multi-centre post market study of the POUNCE Venous Thrombectomy system for de-clotting in the peripheral vasculature (e.g., iliofemoral veins).
详细描述
This PMCF study is designed to further evaluate the safety and performance of the POUNCE Venous Thrombectomy system in the treatment of patients with symptomatic peripheral vascular thrombus through removal of thrombus. The study will collect both qualitative and quantitative data recorded by the investigators during the procedure to further evaluate safety and performance of the device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals aged 18 years or older
- •Patients with peripheral vascular thrombus (e.g., iliofemoral) as confirmed by Doppler Ultrasonography (DUS)
- •Voluntary informed written consent, given before performance of any clinical investigation-related procedure not part of standard medical care, and with the understanding that consent may be withdrawn at any time without prejudice to future medical care
- •Patients who would likely experience benefit from mechanical thrombus removal
排除标准
- •Presence of a stent in the target vein
- •Known aggressive hypercoagulable states such as antiphospholipid antibody syndrome, Protein C/S Deficiency, Antithrombin deficiency, homozygous prothrombin gene mutation or homozygous Factor V Leiden
- •Limb-threatening circulatory compromise
- •Known symptomatic Pulmonary Embolism at the time of enrollment with or without severe RV dysfunction
- •Patients with a positive COVID test result at the time of the procedure
- •Patients who, according to the investigator, have a venous thrombus that may be associated with a prior COVID infection
- •History of, or active heparin induced thrombocytopenia (HIT)
- •Inability to withstand endovascular procedures
- •Life expectancy < 1 year
- •Participation in any other drug or device studies that have not reached the primary endpoint follow up, which could compromise the results of either trial
- •Patient has any concurrent condition that, in the Investigator's opinion, would jeopardize the safety of the subject or compliance with the protocol
- •Likely inability to comply with the protocol or cooperate fully with the investigator and site personnel
- •Known or suspected abuse of alcohol, narcotics or non-prescription drugs that would jeopardize study outcomes in the Investigator's opinion
- •Inability to provide informed consent or to comply with study assessments (e.g., due to cognitive impairment or geographic distance)
结局指标
主要结局
Device Performance
时间窗: 30 days, 1 year
Successful preparation and use of the device to achieve flow restoration, i.e., elimination of a minimum of 50% thrombus (SIR Grade II or Grade III) in the treated target venous segment.
次要结局
未报告次要终点