First - In - Man Study to Assess the Safety and Feasibility of The Bashir™ Endovascular Catheter for the Treatment of Acute Pulmonary Embolism

Study Overview
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Brief Summary
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The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery and peripheral vasculature.

Detailed Description
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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.

Official Title
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First - In - Man Study to Assess the Safety and Feasibility of The Bashir™ Endovascular Catheter for the Treatment of Acute Pulmonary Embolism

Conditions
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Pulmonary Embolism

Intervention / Treatment
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* Drug: r-tPA
* Device: The Bashir™ Endovascular Catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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); Pregnancy; 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Pulse Spray and Infusion of r-tPA
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BEC Treatment<br>The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery. | Drug: r-tPA<br>* Pulse spray and infusion<br>Device: The Bashir™ Endovascular Catheter<br>* The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery and peripheral vasculature.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Number of Participants With Major Bleeding Events | 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 Fatal bleeding; and/or 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 g/dL (1.24 mmol/L) or more or leading to transfusion of two or more units of whole blood or red cells. | Within 72 hours of initiation of r-tPA administration. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary Embolism