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tPA by Endovascular Administration for the Treatment of Submassive PE Using CDT for the Reduction of Thrombus Burden (RESCUE)

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ClinicalTrials.gov Identifier: NCT04248868
Recruitment Status : Recruiting
First Posted : January 30, 2020
Last Update Posted : October 11, 2021
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Thrombolex, Inc.

Brief Summary:
To demonstrate the efficacy and safety of the Bashir™ Endovascular Catheter for the administration of pharmaco-mechanical catheter directed therapy using low dose r-tPA for the treatment of acute submassive pulmonary embolism.

Condition or disease Intervention/treatment Phase
Pulmonary Embolism Device: The Bashir™ Endovascular Catheter Drug: r-tPA Phase 3

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.

This study will utilize the Bashir™ Endovascular Catheter and the Bashir Endovascular Catheter with a short basket (BASHIR™ S-B endovascular catheter) to administer catheter directed thrombolysis in patients with submassive PE who have consented and meet all eligibility criteria. The Bashir™ and BASHIR™ S-B endovascular catheters represent a new methodology for localized catheter-based delivery of thrombolytics. The thrombolytic to be used in this study is r-tPA (Genentech Corporation, South San Francisco, USA).

The design of the Bashir Endovascular Catheter with the multiple infusion limbs creating a basket-like formation when expanded, provides an immediate channel for blood flow through the thrombus and a greater surface area in the thrombus for the endogenous and exogenous thrombolytics to take effect, as described above.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 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: Recombinant tPA by Endovascular Administration for the Treatment of Submassive Pulmonary Embolism Using Pharmaco-mechanical Catheter Directed Thrombolysis for the redUction of Thrombus burdEn
Actual Study Start Date : June 23, 2020
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : September 1, 2022

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.
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.

Drug: r-tPA
Pulse spray and infusion




Primary Outcome Measures :
  1. Efficacy: RV/LV Ratio Difference [ Time Frame: 48 hours after the completion of r-tPA treatment ]
    Observe RV/LV diameter ratio difference between baseline and 48 hours after the completion of r-tPA treatment as measured by contrast enhanced chest CT (CTA).

  2. 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.



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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:

  1. Willing and able to provide informed consent;
  2. Age 18 to ≤ 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 (CTA);
  5. RV/LV 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. CVA or TIA within one (1) year;
  2. Head trauma, active intracranial, or intraspinal disease ≤ one (1) year prior to inclusion in the study;
  3. Active bleeding from a major organ within one (1) month prior to inclusion in the study;
  4. Intracranial condition(s) that may increase the risk of bleeding (e.g., neoplasms, arteriovenous malformations, or aneurysms);
  5. Patients with bleeding diatheses;
  6. Hematocrit < 30%;
  7. Platelets < 100,000/μL;
  8. INR > 1.5 if currently on warfarin (Coumadin®);
  9. aPTT > 50 seconds in the absence of anticoagulants;
  10. Major surgery ≤ 14 days prior to inclusion in the study;
  11. Serum creatinine > 2.0mg/dL;
  12. Clinician deems high-risk for catastrophic bleeding;
  13. History of heparin-induced thrombocytopenia (HIT Syndrome);
  14. Pregnancy;
  15. SBP < 90 mmHg > 15 minutes within two (2) hours prior to BEC procedure and is not resolved with IV fluids;
  16. Any vasopressor support;
  17. Cardiac arrest (including pulseless electrical activity and asystole) requiring active cardiopulmonary resuscitation (CPR) during this hospitalization at treating institution and/or referring institution;
  18. Evidence of irreversible neurological compromise;
  19. Life expectancy < one (1) year;
  20. Use of thrombolytics or glycoprotein IIb/IIIa inhibitor within 3 days prior to inclusion in the study;
  21. Use of non-vitamin K oral anti-coagulants (NOACs), such as rivaroxaban (Xarelto®), apixaban (Eliquis®), dabigatran (Pradaxa®), edoxaban (Savaysa®) 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. BMI > 45kg/m2;
  26. Absolute contraindication to anticoagulation;
  27. Uncontrolled hypertension defined as SBP > 175mmHg and / or DBP > 110mmHg with pharmacotherapy within two (2) hours prior to inclusion in the study;
  28. Currently participating in another study;
  29. Any arterial line placement;
  30. Current positive COVID diagnosis, or ≤ 8 weeks negative of COVID, or > 8 weeks from positive COVID test and with current symptoms, or current active viral pneumonia on chest CT scan;
  31. 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): NCT04248868


Contacts
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Contact: Chris Schultz, BS 719-400-7463 cschultz@ecr-inc.com

Locations
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Sponsors and Collaborators
Thrombolex, Inc.
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Brian Firth, MD, PhD, MBA, FACC Thrombolex, Inc.
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Responsible Party: Thrombolex, Inc.
ClinicalTrials.gov Identifier: NCT04248868    
Other Study ID Numbers: THRO-CLIN-2019-01
First Posted: January 30, 2020    Key Record Dates
Last Update Posted: October 11, 2021
Last Verified: October 2021
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
Catheter Directed Therapy
Additional relevant MeSH terms:
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Pulmonary Embolism
Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases