A Prospective, Single-Arm, Multi-Center Trial of EkoSonic® Endovascular System and Activase for Treatment of Acute Pulmonary Embolism (PE)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 22
- 主要终点
- Number of Participants With Major Bleeding
研究概览
简要总结
The purpose of this study is to determine if the EKOS EkoSonic® Endovascular Device when used in conjunction with recombinant tissue plasminogen activator (t-PA) as a treatment for acute PE will decrease the ratio of right ventricle (RV) to left ventricle (LV) diameter within 48 =/- 6 hours in participants with massive or submassive 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
- •Computed tomography (CT) evidence of proximal PE (filling defect in at least one main or segmental pulmonary artery)
- •PE symptom duration less than or equal to (<=)14 days
- •Informed consent can be obtained from participant or Legally Authorized Representative (LAR)
- •Massive PE (syncope, systemic arterial hypotension, cardiogenic shock, or resuscitated cardiac arrest) or
- •Submassive PE (RV diameter-to-LV diameter greater than or equal to [>=] 0.9 on contrast-enhanced chest CT)
排除标准
- •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
- •Hematocrit less than (<) 30 percent (%)
- •Platelets < 100 thousand/microliter (mcL)
- •International Normalized Ratio (INR) greater than (>) 3
- •Activated partial thromboplastin time (aPTT) >50 seconds on no anticoagulants
- •Major surgery within seven days of screening for study enrollment
- •Serum creatinine >2 milligrams/deciliter (mg/dL)
- •Clinician deems high-risk for catastrophic bleeding
- •History of heparin-induced thrombocytopenia (HIT)
- •Pregnancy
- •Catheter-based pharmacomechanical treatment for pulmonary embolism within 3 days of study enrollment
- •Systolic blood pressure less than 80 mm Hg despite vasopressor or inotropic support
- •Cardiac arrest (including pulseless electrical activity and asystole) requiring active cardiopulmonary resuscitation (CPR)
- •Evidence of irreversible neurological compromise
- •Life expectancy <30 days
- •Use of thrombolytics or glycoprotein IIb/IIIa antagonists within 3 days prior to inclusion in the study
- •Previous enrollment in the SEATTLE study
研究组 & 干预措施
EkoSonic® Endovascular System
Participants will receive a total of 24 milligrams (mg) of recombinant t-PA infusion, at an infusion rate of 1 milligrams/hour (mg/hr) per device (2 mg/hour for bilateral PE) delivered through the EkoSonic® Endovascular System. This regimen allows for a recombinant t-PA infusion time of 24 hours for one catheter and 12 hours for two catheters, respectively.
干预措施: recombinant tissue plasminogen activator (Drug)
EkoSonic® Endovascular System
Participants will receive a total of 24 milligrams (mg) of recombinant t-PA infusion, at an infusion rate of 1 milligrams/hour (mg/hr) per device (2 mg/hour for bilateral PE) delivered through the EkoSonic® Endovascular System. This regimen allows for a recombinant t-PA infusion time of 24 hours for one catheter and 12 hours for two catheters, respectively.
干预措施: EKOS EkoSonic Endovascular System (Device)
结局指标
主要结局
Number of Participants With Major Bleeding
时间窗: From start of study drug infusion up to 72 hours
Bleeding adverse events were graded (severe or life-threatening, moderate or mild bleeding) according to the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) classification. The participant incidence of major bleeding events was defined as GUSTO moderate and severe events occurring within 72 hours after starting the ultrasound-accelerated catheter-directed fibrinolysis procedure. Mild: Does not meet criteria for moderate or severe; Moderate: Requires transfusion - No hemodynamic compromise; and Severe: Bleeding causes hemodynamic compromise and required intervention or intracranial hemorrhage. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Change From Baseline in the Right Ventricle (RV) Diameter-to-Left Ventricle (LV) Diameter Ratio Within 48 +/- 6 Hours of Initiation of Therapy
时间窗: Baseline, within 48 +/- 6 hours of initiation of therapy
Change from baseline in RV diameter/LV diameter ratio was determined by contrast-enhanced chest computed tomography (CT) within 48 +/- 6 hours after initiating ultrasound-accelerated catheter-directed fibrinolysis.
次要结局
- Change From Baseline in Pulmonary Artery Systolic Pressure at 48 Hours After Start of Therapy(Baseline, Hour 48 after initiation of therapy)
- Percentage of Participants With Symptomatic Recurrent Pulmonary Embolism (PE)(Baseline up to Day 30)
- Number of Participants Who Died Due to Any Cause(Baseline up to Day 30)
- Number of Devices That Could Not be Successfully Used for Infusion(Baseline up to Day 30)