First - In - Man Study to Assess the Safety and Feasibility of The Bashir™ Endovascular Catheter for the Treatment of Acute Pulmonary Embolism
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 5
- 主要终点
- Safety: Number of Participants With Major Bleeding Events
研究概览
简要总结
The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery and peripheral vasculature.
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.
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
- •General Inclusion Criteria:
- •Willing and able to provide informed consent;
- •18 years of age and less than 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;
- •RV/LV end diastolic 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
- •Cerebrovascular Accident (CVA) or transient ischemic attack (TIA) within one (1) year;
- •Head trauma, or other active intracranial, or intraspinal disease within one (1) year;
- •Recent (within one month) or active bleeding from a major organ;
- •Intracranial condition(s) that may increase the risk of bleeding (e.g., neoplasms, arteriovenous malformations, or aneurysms);
- •Patients with bleeding diathesis;
- •Hematocrit < 30%;
- •Platelets < 100,000/μL;
- •INR > 1.5;
- •aPTT > 50 seconds in the absence of anticoagulants;
- •Major surgery within fourteen (14) days;
- •Serum creatinine > 2 mg/dL;
- •Clinician deems high-risk for catastrophic bleeding;
- •History of heparin-induced thrombocytopenia (HIT);
- •Systolic blood pressure < 90 mmHg for > 15 minutes;
- •Any vasopressor support;
- •Cardiac arrest (including pulseless electrical activity and asystole) requiring active cardiopulmonary resuscitation (CPR);
- •Evidence of irreversible neurological compromise;
- •Life expectancy < one (1) year;
- •Use of thrombolytics or glycoprotein IIb/IIIa antagonists within 3 days prior to inclusion in the study;
- •Use of non-vitamin K oral anti-coagulants (NOACs), such as Rivaroxaban, Apixaban, Dabigatran, Edoxaban within 48 hours prior to inclusion in the study;
- •Use of enoxaparin sodium injection (Lovenox®) within 12 hours of procedure start time;
- •Profound bradycardia requiring a temporary pacemaker and/or inotropic support;
- •Previous enrollment in this study;
- •Morbidly obese (BMI >45 kg/m2) patient who by the judgement of the investigator is high risk for bleeding;
- •Absolute contraindication to anticoagulation;
- •Uncontrolled hypertension;
- •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: r-tPA (Drug)
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)
结局指标
主要结局
Safety: Number of Participants With Major Bleeding Events
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