Recombinant tPA by Endovascular Pulse 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
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Primary Safety Endpoint, major bleeding, as defined by International Society of Thrombosis and Hemostasis (ISTH), within 72 hours of initiation of rtPA infusion. ISTH major bleeding in non-surgical patients is defined as having a symptomatic presentation
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 pulse spray of r-tPA for the treatment of acute submassive pulmonary embolism
详细描述
Study Objective To demonstrate the efficacy and safety of the Bashir™ and Bashir™ S-B Endovascular Catheters for the administration of pharmaco- mechanical catheter directed therapy in a pulse spray mode using low dose r-tPA for the treatment of acute submassive pulmonary embolism. Endpoints Primary Efficacy Endpoint Reduction in RV/LV diameter ratio as measured by CTA within 48 hours after the completion of r-tPA treatment.
Primary Safety Endpoint Major bleeding, as defined by International Society of Thrombosis and Hemostasis (ISTH), within 72 hours of initiation of r- tPA infusion. ISTH major bleeding in non-surgical patients is defined as having a symptomatic presentation and:
a. Fatal bleeding; and/or b. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra- articular or pericardial, or intramuscular with compartment syndrome; and/or c. Bleeding causing a fall in hemoglobin level of 2.0g/dL (1.24mmol/L) or more or leading to transfusion of two or more units of whole blood or red cells. Secondary Endpoints
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Refined Modified Miller Score as measured on CTA within 48 hours after the completion of the r-tPA infusion compared to baseline as measured by core lab. 25
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All-cause mortality at hospital discharge through 30-day follow-up.
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SAEs through 30-day follow-up.
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AEs through 30-day follow-up.
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UADEs through 30-day follow-up.
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Recurrent PE through 30-day follow-up.
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Clinically Relevant Non-Major bleeding: Any sign or symptom of hemorrhage (e.g. more bleeding than would be expected for a clinical circumstance, including bleeding found by imaging alone) that does not fit the criteria for the ISTH definition of major bleeding but does meet at least one of the following criteria:
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Requiring medical intervention by a healthcare professional.
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Leading to hospitalization or increased level of care.
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Prompting a face to face (i.e., not just a telephone or electronic communication) evaluation.
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Technical procedural complications.
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Systolic PA pressure measured at completion of pulse sprays and after BEC(s) removal and compared to baseline.
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Cardiac output (CO by Modified Fick calculation) and cardiac index (CI) following completion of the r-tPA pulse sprays compared to the baseline. Please refer to Terms and Definitions section for the Modified Fick calculation to be done in the IR suite / cath lab at baseline and after BEC removal).
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
- •Inclusion Criteria
- •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 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;
- •Profound bradycardia requiring a temporary pacemaker and/or inotropic support;
- •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;
- •In the opinion of the investigator, the subject is not a suitable candidate for the study
结局指标
主要结局
Primary Safety Endpoint, major bleeding, as defined by International Society of Thrombosis and Hemostasis (ISTH), within 72 hours of initiation of rtPA infusion. ISTH major bleeding in non-surgical patients is defined as having a symptomatic presentation
时间窗: 72 hours
Major bleeding, as defined by International Society of Thrombosis and Hemostasis (ISTH), within 72 hours of initiation of rtPA infusion. ISTH major bleeding in non-surgical patients is defined as having a symptomatic presentation and: 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 Bleeding causing a fall in hemoglobin level of 2.0g/dL (1.24mmol/L) or more or leading to transfusion of two or more units of whole blood or red cells
Reduction in RV/LV diameter ratio as measured by contrast enhanced chest CT from baseline within 48 ± 6 hours of initiation of treatment. chest CT (CTA) within 48 hours after the completion of r-tPA treatment
时间窗: Through 30 day follow-up
Reduction in RV/LV diameter ratio as measured by contrast enhanced chest CT (CTA) within 48 hours after the completion of r-tPA treatment
次要结局
- Clinically relevant non-major bleeding(30 days)
- Refined Modified Miller Score(Within 48 hours of completion of r-TPA)
- Serious adverse events(30 days)
- Adverse events(30 days)
- All-cause mortality(30 DAYS)
- Unanticipated adverse device events(30 days)
- Recurrent pulmonary embolism through 30-day follow-up.(30 days)
- Systolic PA pressure(Once r-tPA pulse sprays are given continue therapeutic anticoagulation with full does heparin or LMWH with sheaths sutured in place)
- Cardiac output (CO by Modified Fick calculation) and cardiac index (CI) following completion of the r-tPA pulse(End of procedure)
- Technical procedural complications.(1 day)