Selective Pulmonary-artery Intervention to Reduce Acute Right-heart tEnsion-II
概览
- 阶段
- 不适用
- 干预措施
- Vertex Pulmonary Embolectomy System
- 疾病 / 适应症
- Pulmonary Embolism
- 发起方
- Jupiter Endovascular
- 入组人数
- 123
- 试验地点
- 37
- 主要终点
- Reduction in Right ventricle (RV) / Left Ventricle (LV) ratio
- 状态
- 已完成
- 最后更新
- 26天前
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.
研究者
入排标准
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
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
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