Recombinant tPA by Endovascular Administration for the Treatment of Submassive Pulmonary Embolism Using Pharmaco-mechanical Catheter Directed Thrombolysis for the redUction of Thrombus burdEn
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 19
- 主要终点
- Efficacy: RV/LV Ratio Difference
研究概览
简要总结
To demonstrate the efficacy and safety of the Bashir™ Endovascular Catheter for the administration of pharmaco-mechanical catheter directed therapy using low dose r-tPA for the treatment of acute submassive pulmonary embolism.
详细描述
The Bashir™ Endovascular Catheter has been designed to administer therapeutic agents in the peripheral vasculature. Because of the unique design of the catheter, with its six expandable infusion limbs, the Bashir™ Endovascular Catheter has the ability to: 1. Create a much larger central channel for blood flow, thereby utilizing the body's own endogenous fibrinolytic agents to lyse the clot, and 2. Greatly enhance the radial dispersion of a catheter-administered thrombolytic agent throughout the thrombus. Expansion of the multiple arms of the basket in the infusion catheter causes fissuring of the clot. The net result is that a greater surface area of clot is exposed to both endogenous and exogenously administered lytic agents, thereby promoting clot dissolution.
This study will utilize the Bashir™ Endovascular Catheter and the Bashir Endovascular Catheter with a short basket (BASHIR™ S-B endovascular catheter) to administer catheter directed thrombolysis in patients with submassive PE who have consented and meet all eligibility criteria. The Bashir™ and BASHIR™ S-B endovascular catheters represent a new methodology for localized catheter-based delivery of thrombolytics. The thrombolytic to be used in this study is r-tPA (Genentech Corporation, South San Francisco, USA).
The design of the Bashir Endovascular Catheter with the multiple infusion limbs creating a basket-like formation when expanded, provides an immediate channel for blood flow through the thrombus and a greater surface area in the thrombus for the endogenous and exogenous thrombolytics to take effect, as described above.
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
- •Willing and able to provide informed consent;
- •Age 18 to ≤ 75 years of age;
- •PE symptom duration ≤ 14 days.
- •Filling defect in at least one main or lobar pulmonary artery as determined by contrast enhanced chest CT (CTA);
- •RV/LV diameter ratio ≥ 0.9 by CTA as determined by the investigative site;
- •Willing and able to comply with all study procedures and follow-up.
排除标准
- •CVA or TIA within one (1) year;
- •Head trauma, active intracranial, or intraspinal disease ≤ one (1) year prior to inclusion in the study;
- •Active bleeding from a major organ within one (1) month prior to inclusion in the study;
- •Intracranial condition(s) that may increase the risk of bleeding (e.g., neoplasms, arteriovenous malformations, or aneurysms);
- •Patients with bleeding diatheses;
- •Hematocrit < 30%;
- •Platelets < 100,000/μL;
- •INR > 1.5 if currently on warfarin (Coumadin®);
- •aPTT > 50 seconds in the absence of anticoagulants;
- •Major surgery ≤ 14 days prior to inclusion in the study;
- •Serum creatinine > 2.0mg/dL;
- •Clinician deems high-risk for catastrophic bleeding;
- •History of heparin-induced thrombocytopenia (HIT Syndrome);
- •SBP < 90 mmHg > 15 minutes within two (2) hours prior to BEC procedure and is not resolved with IV fluids;
- •Any vasopressor support;
- •Cardiac arrest (including pulseless electrical activity and asystole) requiring active cardiopulmonary resuscitation (CPR) during this hospitalization at treating institution and/or referring institution;
- •Evidence of irreversible neurological compromise;
- •Life expectancy < one (1) year;
- •Use of thrombolytics or glycoprotein IIb/IIIa inhibitor within 3 days prior to inclusion in the study;
- •Use of non-vitamin K oral anti-coagulants (NOACs), such as rivaroxaban (Xarelto®), apixaban (Eliquis®), dabigatran (Pradaxa®), edoxaban (Savaysa®) within 48 hours prior to inclusion in the study;
- •Profound bradycardia requiring a temporary pacemaker and/or inotropic support;
- •Previous enrollment in this study;
- •Morbidly obese patient who by the judgement of the investigator is high risk for bleeding;
- •BMI > 45kg/m2;
- •Absolute contraindication to anticoagulation;
- •Uncontrolled hypertension defined as SBP > 175mmHg and / or DBP > 110mmHg with pharmacotherapy within two (2) hours prior to inclusion in the study;
- •Currently participating in another study;
- •Any arterial line placement;
- •Current positive COVID diagnosis, or ≤ 8 weeks negative of COVID, or > 8 weeks from positive COVID test and with current symptoms, or current active viral pneumonia on chest CT scan;
- •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: RV/LV Ratio Difference
时间窗: 48 hours after the completion of r-tPA treatment
Observe RV/LV diameter ratio difference between baseline and 48 hours after the completion of r-tPA treatment as measured by contrast enhanced chest CT (CTA).
Safety: Major Bleeding
时间窗: Within 72 hours of initiation of r-tPA administration
Major Bleeding as defined by International Society of Thrombosis and Hemostasis (ISTH), within 72 hours of initiation of r-tPA administration. Bleeding criteria are as follows: Major Bleeding in Non-Surgical Patients 1. Fatal bleeding; and/or 2. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome; and/or 3. Bleeding causing a fall in hemoglobin level of 2 g/dL (1.24 mmol/L) or more or leading to transfusion of two or more units of whole blood or red cells.
次要结局
未报告次要终点