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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03927508
Recruitment Status : Active, not recruiting
First Posted : April 25, 2019
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pulmonary Embolism Drug: r-tPA Device: The Bashir™ Endovascular Catheter 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
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 14, 2019
Actual Primary Completion Date : December 3, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


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.




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

    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years 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 < 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. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03927508


Locations
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United States, Florida
Advent Health Orlando
Orlando, Florida, United States, 32803
United States, Indiana
St Vincent Hospital and Health Care Center, Inc.
Indianapolis, Indiana, United States, 46260
United States, New York
Columbia University Medical Center - Presbyterian - New York
New York, New York, United States, 10032
United States, Pennsylvania
University Pittsburg Medical Center - Hamot
Erie, Pennsylvania, United States, 16507
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
Thrombolex, Inc.
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Responsible Party: Thrombolex, Inc.
ClinicalTrials.gov Identifier: NCT03927508    
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

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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:
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Pulmonary Embolism
Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases