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出境医 / 临床实验 / First - In - Man Study to Assess the Safety and Feasibility of The Bashir™ Endovascular Catheter for the Treatment of Acute Pulmonary Embolism

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

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 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.
Study Design
Layout table for study information
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
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

    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.


Eligibility Criteria
Layout table for eligibility information
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.
Contacts and Locations

Locations
Layout table for location information
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.
Tracking Information
First Submitted Date  ICMJE April 23, 2019
First Posted Date  ICMJE April 25, 2019
Last Update Posted Date January 22, 2020
Actual Study Start Date  ICMJE March 14, 2019
Actual Primary Completion Date December 3, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2019) 		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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 23, 2019)
  • 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.
  • Feasibility: Device Success [ Time Frame: Index procedure ]
    Device success defined as the ability to use the Bashir™ Endovascular Catheter.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE First - In - Man Study to Assess the Safety and Feasibility of The Bashir™ Endovascular Catheter for the Treatment of Acute Pulmonary Embolism
Official Title  ICMJE First - In - Man Study to Assess the Safety and Feasibility of The Bashir™ Endovascular Catheter for the Treatment of Acute Pulmonary Embolism
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE 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
Condition  ICMJE Pulmonary Embolism
Intervention  ICMJE
  • 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.
Study Arms  ICMJE Experimental: BEC Treatment
The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery.
Interventions:
  • Drug: r-tPA
  • Device: The Bashir™ Endovascular Catheter
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: April 23, 2019) 		10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Actual Primary Completion Date December 3, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03927508
Other Study ID Numbers  ICMJE THRO-CLIN-2018-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Thrombolex, Inc.
Study Sponsor  ICMJE Thrombolex, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Thrombolex, Inc.
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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