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

Phase 1

Completed

• Conditions: Pulmonary Embolism
• Interventions: Drug: r-tPA; Device: The Bashir™ Endovascular Catheter

• Registration Number: NCT03927508
• Lead Sponsor: Thrombolex, Inc.

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2019-03-14
• Study First Submitted: 2019-04-23
• Study First Submitted QC: 2019-04-23
• Study First Posted: 2019-04-25
• Primary Completion: 2019-12-19
• Study Completion: 2020-01-23
• Results First Submitted: 2020-02-10
• Status Verified: 2023-03
• Results First Submitted QC: 2023-03-29
• Last Update Submitted: 2023-03-29
• Results First Posted: 2023-03-30
• Last Update Posted: 2023-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

General Inclusion Criteria:

1. Willing and able to provide informed consent;
2. 18 years of age and less than 75 years of age;
3. PE symptom duration ≤ 14 days;
4. Filling defect in at least one main or lobar pulmonary artery as determined by contrast enhanced chest CT;
5. RV/LV end diastolic diameter ratio ≥ 0.9 by CTA as determined by the investigative site;
6. Willing and able to comply with all study procedures and follow-up.

Exclusion Criteria

1. Cerebrovascular Accident (CVA) or transient ischemic attack (TIA) within one (1) year;
2. Head trauma, or other active intracranial, or intraspinal disease within one (1) year;
3. Recent (within one month) or active bleeding from a major organ;
4. Intracranial condition(s) that may increase the risk of bleeding (e.g., neoplasms, arteriovenous malformations, or aneurysms);
5. Patients with bleeding diathesis;
6. Hematocrit < 30%;
7. Platelets < 100,000/μL;
8. INR > 1.5;
9. aPTT > 50 seconds in the absence of anticoagulants;
10. Major surgery within fourteen (14) days;
11. Serum creatinine > 2 mg/dL;
12. Clinician deems high-risk for catastrophic bleeding;
13. History of heparin-induced thrombocytopenia (HIT);
14. Pregnancy;
15. Systolic blood pressure < 90 mmHg for > 15 minutes;
16. Any vasopressor support;
17. Cardiac arrest (including pulseless electrical activity and asystole) requiring active cardiopulmonary resuscitation (CPR);
18. Evidence of irreversible neurological compromise;
19. Life expectancy < one (1) year;
20. Use of thrombolytics or glycoprotein IIb/IIIa antagonists within 3 days prior to inclusion in the study;
21. Use of non-vitamin K oral anti-coagulants (NOACs), such as Rivaroxaban, Apixaban, Dabigatran, Edoxaban within 48 hours prior to inclusion in the study;
22. Use of enoxaparin sodium injection (Lovenox®) within 12 hours of procedure start time;
23. Profound bradycardia requiring a temporary pacemaker and/or inotropic support;
24. Previous enrollment in this study;
25. Morbidly obese (BMI >45 kg/m2) patient who by the judgement of the investigator is high risk for bleeding;
26. Absolute contraindication to anticoagulation;
27. Uncontrolled hypertension;
28. Currently participating in another study;
29. In the opinion of the investigator, the subject is not a suitable candidate for the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BEC Treatment	r-tPA	The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery.
BEC Treatment	The Bashir™ Endovascular Catheter	The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery.

Primary Outcome Measures

Name	Time	Method
Safety: Number of Participants With Major Bleeding Events	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.

Trial Locations

Locations (5)

Advent Health Orlando; 🇺🇸 Orlando, Florida, United States

St Vincent Hospital and Health Care Center, Inc.; 🇺🇸 Indianapolis, Indiana, United States

Columbia University Medical Center - Presbyterian - New York; 🇺🇸 New York, New York, United States

University Pittsburg Medical Center - Hamot; 🇺🇸 Erie, Pennsylvania, United States

Temple University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States