Single-dose rtPA Thrombolysis Endovascular Treatment of Pulmonary Embolism With Right Ventricular Dysfunction:a Pilot Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change of RV to LV Diameter Ratio
研究概览
简要总结
To assess the efficacy and safety of endovascular thrombolysis of pulmonary embolism with right ventricular dysfunction with single-dose rtPA
详细描述
The patients with right ventricular dysfunction who are diagnosed by CT pulmonary angiography will receive 20 mg of single-dose recombinant tissue plasminogen activator delivered through the in this study. The Change of RV to LV Diameter Ratio,Rate of death,rate of major bleeding,pulmonary embolism recurrence at 1month will be reviewed to assess the efficacy and safety.
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
- •CT evidence of proximal PE
- •Age ≥ 18 years
- •Pulmonary embolism symptom duration ≤14 days
- •Massive PE (syncope, systemic arterial hypotension, cardiogenic shock, or resuscitated cardiac arrest) OR Submassive PE (RV diameter-to-LV diameter ≥ 0.9 on contrast-enhanced chest CT)
排除标准
- •Age <18 years
- •PE symptom duration >14 days
- •Stroke or transient ischemic attack (TIA), head trauma, or other active intracranial or intraspinal disease within one year
- •Recent (within one month) or active bleeding from a major organ
- •Pregnancy
- •Chronic pulmonary hypertension or severe chronic obstructive pulmonary disease
- •Administration of thrombolytic agents within the previous 3 days
- •Life expectancy < 30 days
- •Any other condition that the investigator feels would place the patient at increased risk if the investigational therapy is initiated
- •Inability to follow protocol requirements
研究组 & 干预措施
Intervention arm
Patients receive 20 mg of single-dose recombinant tissue plasminogen activator delivered through the catheter
干预措施: recombinant tissue plasminogen activator (Drug)
结局指标
主要结局
Change of RV to LV Diameter Ratio
时间窗: baseline and 30days after baseline
Determine whether single-dose rtpa catheter-directed thrombolysis decrease the ratio of right ventricular (RV)-to-left ventricular (LV) diameter within 1month in patients with right ventricular dysfunction
次要结局
- Rate of major Bleeding(30days)
- Pulmonary embolism recurrence(30days)
- Rate of death(30days)