The RAPID - PE Study: RESCUE Advanced Protocol Without ICU Stay and no Lytic Drip - for the Treatment of Pulmonary Embolism
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 23
- 主要终点
- Efficacy: Death from any cause or hemodynamic decompensation (or collapse)
研究概览
简要总结
To demonstrate the efficacy and safety of the 8F BASHIR™ .035 Endovascular Catheter and the 8F BASHIR™ S-B .035 Endovascular Catheter for the administration of pharmaco-mechanical catheter directed therapy using pulse sprays of r-tPA into the pulmonary arteries for the treatment of intermediate risk pulmonary embolism (PE).
详细描述
The BASHIR™ .035 Endovascular Catheter (BEC) and the BEC Short Basket .035 (S-B) are devices intended for the localized infusion of therapeutic agents into the pulmonary artery and peripheral vasculature. The distal infusion segment of the device contains an expandable radial array of conduits with a total of 48 laser drilled orifices used for the delivery of the therapeutic agents at multiple cross-sectional points of the target vessel location. The infusion segment can be expanded and collapsed by the actuator (slider) located on the handle at the proximal end of the device. The infusion line connector is also located on the handle. The difference between the BEC .035 and the BEC S-B.035 is solely in the length of the basket. In its unexpanded state, the basket of the BEC .035 is 12.5cm long and the BEC S-B .035 basket is 10cm long. The choice of device used will be at the physician's discretion based on the patient's anatomy.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to provide informed consent;
- •PE symptom duration ≤ 15 days;
- •Filling defect in at least one major lobar pulmonary artery as determined by CTA;
- •Patient is diagnosed with intermediate risk PE;
- •RV/LV diameter ratio ≥ 0.9 by CTA, as determined by investigative site;
- •Willing and able to comply with all study procedures and 7-day and 30-day telephone follow-up visit.
排除标准
- •Previous history of stroke with residual hemiplegia;
- •Major surgery ≤ 10 days prior to inclusion in the study;
- •Platelet count < 100,000/μL;
- •Pulmonary thrombectomy within the previous 4 days;
- •Uncontrolled hypertension defined as systolic blood pressure >180 mm Hg and/or diastolic blood pressure >110 mm Hg at the time of the procedure;
- •Administration of thrombolytic agents within the previous 4 days;
- •Absolute contraindication to anticoagulation;
- •Clinician deems high-risk for catastrophic bleeding;
- •Any vasopressor or inotropic support;
- •Cardiac arrest (including pulseless electrical activity (PEA) and asystole) requiring active cardiopulmonary resuscitation (CPR) during this hospitalization at treating institution and/or referring institution;
- •Planning to administer r-tPA by infusion after the r-tPA is administered by pulse sprays;
- •Currently participating in another study;
- •In the opinion of the investigator, the subject is not a suitable candidate for the study.
研究组 & 干预措施
BEC Treatment
The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery.
干预措施: The Bashir™ Endovascular Catheter (Device)
BEC Treatment
The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery.
干预措施: r-tPA (Drug)
结局指标
主要结局
Efficacy: Death from any cause or hemodynamic decompensation (or collapse)
时间窗: Procedure through 7-day follow-up
Observe death from any cause or hemodynamic decompensation (or collapse) through 7-day follow-up, defined as need for cardiopulmonary resuscitation; or 1. SBP \< 90 mmHg for at least 15 minutes; or 2. drop in SBP by at least 40 mmHg for at least 15 minutes with signs of end-organ hypoperfusion (cold extremities or low urinary output \< 30 mL/h or mental confusion); or 3. need for catecholamine administration to maintain adequate organ perfusion and a SBP \> 90 mmHg (including dopamine at the rate of \> 5 micrograms / kg per minute).
次要结局
未报告次要终点