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

NCT ID: NCT03927508

Last Updated: 2023-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-14
• Study Completion Date: 2020-01-23

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.

Conditions

Pulmonary Embolism

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BEC Treatment

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

Group Type: EXPERIMENTAL

r-tPA

Intervention Type: DRUG

Pulse spray and infusion

The Bashir™ Endovascular Catheter

Intervention Type: DEVICE

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

Interventions

r-tPA

Pulse spray and infusion

Intervention Type: DRUG

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thrombolex, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

United States

References

Sista AK, Bhatheja R, Rali P, Natarajan K, Green P, Piazza G, Comerota AJ, Parikh SA, Lakhter V, Bashir R, Rosenfield K. First-in-Human Study to Assess the Safety and Feasibility of the Bashir Endovascular Catheter for the Treatment of Acute Intermediate-Risk Pulmonary Embolism. Circ Cardiovasc Interv. 2021 Jan;14(1):e009611. doi: 10.1161/CIRCINTERVENTIONS.120.009611. Epub 2020 Dec 24.

Reference Type: DERIVED

PMID: 33356383 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

THRO-CLIN-2018-01

Identifier Type: -

Identifier Source: org_study_id