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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

  • Clinicaltrials.gov identifier

    NCT03927508

  • Recruitment Status

    Active, not recruiting

  • First Posted

    April 25, 2019

  • Last update posted

    January 22, 2020

Study Description

Brief summary:

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

  • Condition or Disease:Pulmonary Embolism
  • Intervention/Treatment: Drug: r-tPA
    Device: The Bashir™ Endovascular Catheter
  • Phase: Phase 1

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 Design

  • Study Type: Interventional
  • Estimated Enrollment: 10 participants
  • Intervention Model: Single Group Assignment
  • Intervention Model Description: Pulse Spray and Infusion of r-tPA
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: First - In - Man Study to Assess the Safety and Feasibility of The Bashir™ Endovascular Catheter for the Treatment of Acute Pulmonary Embolism
  • Actual Study Start Date: March 2019
  • Estimated Primary Completion Date: December 2019
  • Actual Study Completion Date: December 2020

Arms and interventions

Arm Intervention/treatment
Experimental: BEC Treatment
The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery.
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.

Outcome Measures

  • Primary Outcome Measures: 1. Safety: Major Bleeding [ Time Frame: 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 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.

Eligibility Criteria

  • Ages Eligible for Study: 18 to 75 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

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 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 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. Profound bradycardia requiring a temporary pacemaker and/or inotropic support; 23. Previous enrollment in this study; 24. Morbidly obese patient who by the judgement of the investigator is high risk for bleeding; 25. Absolute contraindication to anticoagulation; 26. Uncontrolled hypertension; 27. Currently participating in another study; 28. In the opinion of the investigator, the subject is not a suitable candidate for the study.

Contacts and Locations

Contacts

Locations

United States, Florida
Advent Health Orlando
Orlando

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

United States, New York
Columbia University Medical Center - Presbyterian - New York
New York

United States, Pennsylvania
University Pittsburg Medical Center - Hamot
Erie

United States, Pennsylvania
Temple University Hospital
Philadelphia

Sponsors and Collaborators

Thrombolex, Inc.

More Information

  • Responsible Party: Thrombolex, Inc.
  • ClinicalTrials.gov Identifier: NCT03927508 History of Changes
  • Other Study ID Numbers: THRO-CLIN-2018-01
  • First Posted: April 25, 2019 Key Record Dates
  • Last Update Posted: January 22, 2020
  • Last Verified: January 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: Yes
  • Keywords provided by Thrombolex, Inc.: Pulmonary Embolism
  • Additional relevant MeSH terms: Pulmonary Embolism Embolism