NCT03218566已完成不适用
A Prospective, Multicenter Trial to Evaluate the Safety and Efficacy of the Indigo® Aspiration System in Acute Pulmonary Embolism
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 42
- 主要终点
- Major Adverse Event Rate
研究概览
简要总结
To determine the safety and efficacy of the Indigo Aspiration System for aspiration mechanical thrombectomy in patients with acute pulmonary embolism (PE)
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical signs and symptoms consistent with acute PE with duration of 14 days or less. Evidence of PE must be from CTA.
- •Systolic BP ≥ 90 mmHg with evidence of dilated RV with an RV/LV ratio > 0.9
- •Patient is 18 years of age or older
排除标准
- •tPA use within 14 days prior to baseline CTA
- •Systolic BP < 90mmHg for 15min or the requirement of inotropic support to maintain systolic BP ≥ 90 mmHg
- •Pulmonary hypertension with peak PA > 70 mmHg by right heart catheterization
- •History of severe or chronic pulmonary hypertension
- •Fi02 requirement > 40% or >6 LPM to keep oxygen saturations >90%
- •Hematocrit < 28%
- •Platelets < 100,000µL
- •Serum creatinine > 1.8 mg/dL
- •aPTT (or PTT) > 50 seconds on no anticoagulation
- •History of heparin-induced thrombocytopenia (HIT)
- •Contraindication to systemic or therapeutic doses of anticoagulants
- •Major trauma < 14 days
- •Presence of intracardiac lead
- •Cardiovascular or pulmonary surgery within last 7 days
- •Cancer requiring active chemotherapy
- •Known serious, uncontrolled sensitivity to radiographic agents
- •Life expectancy < 90 days
- •Female who is pregnant
- •Intracardiac Thrombus
- •Patients on ECMO
- •Current participation in another investigational study
结局指标
主要结局
Major Adverse Event Rate
时间窗: within 48 hours
A composite of: device-related death, major bleeding, device-related SAEs (a composite of clinical deterioration, pulmonary vascular injury, cardiac injury)
Right Ventricle/Left Ventricle (RV:LV) Ratio
时间窗: from baseline to 48 hours
Change in RV/LV ratio per CTA
次要结局
- Pulmonary Vascular Injury Rate(within 48 hours)
- Cardiac Injury Rate(within 48 hours)
- Any-cause Mortality(within 30 days)
- Device-related SAE Rate(within 30 days)
- Symptomatic PE Recurrence Rate(within 30 days)
- Device-related Death Rate(within 48 hours)
- Major Bleeding Rate(within 48 hours)
- Clinical Deterioration Rate(within 48 hours)
研究者
研究点 (42)
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