Selective Pulmonary-artery Intervention to Reduce Acute Right-heart tEnsion-II
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 123
- 试验地点
- 37
- 主要终点
- Reduction in Right ventricle (RV) / Left Ventricle (LV) ratio
研究概览
简要总结
This study is a prospective, single-arm, multicenter study to evaluate the safety and effectiveness of the Vertex Pulmonary Embolectomy System in participants presenting with clinical signs and symptoms of acute pulmonary embolism.
详细描述
The study is a prospective, single-arm, multicenter study to evaluate the safety and effectiveness of the Vertex Pulmonary Embolectomy System in participants presenting with clinical signs and symptoms of acute pulmonary embolism.
The Vertex Pulmonary Embolectomy System is intended for the non-surgical removal of emboli and thrombi from blood vessels as a means for treating pulmonary embolism.
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
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •. Age ≥ 18 years < 80 years
- •Acute onset of symptoms < 14 days consistent with the presence of pulmonary embolism.
- •CTA evidence (site determined) of proximal PE (filling defect in at least one main or interlobar pulmonary artery)
- •RV/LV ratio of > 0.9 on CTA as assessed by investigator (site determined).
- •Systolic blood pressure ≥ 90 mmHg (initial SBP may be ≥ 80 mmHg if the pressure recovers to ≥ 90 mmHg with fluids)
- •Subject or subject's legally authorized representative (LAR) - applicable for US is willing and able to provide written informed consent prior to receiving any non-standard of care Clinical Investigation Plan-specific procedures
- •Subject is willing and able to comply with all Clinical Investigation Plan required follow-up visits
排除标准
- •Thrombolytic use within 30 days of baseline CTA
- •Pulmonary hypertension with peak pulmonary artery pressure > 70 mmHg by right heart catheterization (site determined)
- •Vasopressor requirement after fluids to keep pressure ≥ 90 mmHg
- •Unstable heart rate > 130 beats per minute prior to procedure
- •FiO2 requirement > 40% or > 6 LPM to keep oxygen saturation > 90%
- •Hematocrit < 28%
- •Platelets < 100,000/μL
- •Serum baseline creatinine > 1.8 mg/dL
- •International normalized ratio (INR) > 3
- •Major trauma injury severity score (ISS) > 15 within the past 14 days
- •Presence of intracardiac lead in the right ventricle or right atrium placed <180 days prior to the index procedure
- •Cardiovascular or pulmonary surgery within last 30 days
- •Actively progressing cancer requiring chemotherapy
- •Known bleeding diathesis or coagulation disorder
- •Left bundle branch block
- •History of severe or chronic pulmonary arterial hypertension
- •History of chronic left heart disease with left ventricular ejection fraction ≤ 30%
- •History of decompensated heart failure
- •Patients on extracorporeal membrane oxygenation (ECMO)
- •History of underlying lung disease that is oxygen dependent
- •History of chest irradiation
- •History of heparin-induced thrombocytopenia (HIT)
- •Contraindication to systemic or therapeutic doses of heparin or anticoagulants
- •Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated
- •Imaging evidence or other evidence that suggests, in the opinion of the Investigator, the Subject is not appropriate for mechanical thrombectomy intervention
- •Life expectancy of < 365 days, as determined by Investigator
- •Female who is pregnant or nursing
- •Current participation in another investigational drug or device treatment study
- •Inability to lay flat for procedure
- •Known presence of right-to-left cardiac shunt
- •History of Hemorrhagic or Ischemic Stroke, including Transient Ischemic Attack, within last 90 days
- •Current or history of chronic thromboembolic pulmonary hypertension (CTEPH) or chronic thromboembolic disease (CTED) diagnosis
研究组 & 干预措施
Vertex Pulmonary Embolectomy System
Patients presenting with clinical signs and symptoms of acute PE and who meet the study criteria will be treated with the Vertex Pulmonary Embolectomy System
干预措施: Vertex Pulmonary Embolectomy System (Device)
结局指标
主要结局
Reduction in Right ventricle (RV) / Left Ventricle (LV) ratio
时间窗: From baseline to 48 hours or discharge
Reduction in RV/LV ratio from baseline to 48 hours or discharge by (core lab assessed) CT angiography
Major Adverse Events, a composite of:
时间窗: Within 48 hours of the procedure
Device-related death within 48 hours of the procedure Major bleeding within 48 hours of the procedure Device-related AEs within 48 hours, including: * Clinical deterioration * Pulmonary vascular injury * Cardiac injury
次要结局
未报告次要终点