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

Pulmonary Embolism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03927508
• Other study ID #: THRO-CLIN-2018-01
• Status: Completed
• Phase: Phase 1
• Start date: March 14, 2019
• Est. completion date: January 23, 2020

Study information

• Verified date: March 2023
• Source: Thrombolex, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: January 23, 2020
• Est. primary completion date: December 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Intervention

Drug:
• r-tPA
Pulse spray and infusion

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

Locations

Country	Name	City	State
United States	University Pittsburg Medical Center - Hamot	Erie	Pennsylvania
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	Advent Health Orlando	Orlando	Florida
United States	Temple University Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thrombolex, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.