NCT02692586已完成不适用
FlowTriever Pulmonary Embolectomy Clinical Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 18
- 主要终点
- Change in RV/LV Ratio
研究概览
简要总结
Evaluate the safety and effectiveness of the FlowTriever System for use in the removal of emboli from the pulmonary arteries in the treatment of acute 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical signs, symptoms and presentation consistent with acute PE
- •PE symptom duration ≤ 14 days
- •CTA evidence of proximal PE
- •RV/LV ratio ≥ 0.9 without syncope
- •Systolic BP ≥ 90 mmHg
- •Stable heart rate <130 BPM prior to procedure
- •Patient deemed medically eligible for interventional procedure(s), per institutional guidelines and/or clinical judgment
排除标准
- •Thrombolytic use within 30 days of baseline CTA
- •Pulmonary hypertension with peak PAP > 70 mmHg by right heart catheterization
- •Vasopressor requirement after fluids to keep pressure ≥ 90 mm Hg
- •FiO2 requirement > 40% or > 6 LPM to keep oxygen saturation > 90%
- •Hematocrit < 28% within 6 hours of index procedure
- •Platelets < 100,000/µL
- •Serum creatinine > 1.8 mg/dL
- •Major trauma ISS > 15
- •Presence of intracardiac lead in right ventricle or atrium placed within 6 months
- •Cardiovascular or pulmonary surgery within last 7 days
- •Actively progressing cancer
- •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 uncompensated heart failure
- •History of underlying lung disease that is oxygen-dependent
- •History of chest irradiation
- •History of Heparin-induced thrombocytopenia
- •Any 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 the subject is not appropriate for mechanical thrombectomy intervention
- •Life expectancy of < 90 days
- •Female who is pregnant or nursing
- •Current participation in another investigational drug or device treatment study
结局指标
主要结局
Change in RV/LV Ratio
时间窗: Baseline to 48 hours
Change in RV/LV ratio from baseline to 48 hours
Number of Participants With Major Adverse Events
时间窗: Within 48 hours
Device-related death, major bleeding, and treatment related AEs
次要结局
未报告次要终点
研究者
研究点 (18)
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