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

NCT ID: NCT04248868

Last Updated: 2023-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 109 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-23
• Study Completion Date: 2022-06-23

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.

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.

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

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.

r-tPA

Intervention Type: DRUG

Pulse spray and infusion

Interventions

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

r-tPA

Pulse spray and infusion

Intervention Type: DRUG

Eligibility 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.

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

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Thrombolex, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brian Firth, MD, PhD, MBA, FACC

Role: PRINCIPAL_INVESTIGATOR

Thrombolex, Inc.

Locations

UCLA

Los Angeles, California, United States

Miami Cardiac & Vascular Institute

Miami, Florida, United States

Advent Health Orlando

Orlando, Florida, United States

Emory

Atlanta, Georgia, United States

Piedmont Heart Institute

Atlanta, Georgia, United States

Loyola University Chicago

Maywood, Illinois, United States

Ascension St. Vincent

Indianapolis, Indiana, United States

Ascension St. John Hospital

Detroit, Michigan, United States

Beaumont Hospital, Royal Oak

Royal Oak, Michigan, United States

University of Minnesota

Minneapolis, Minnesota, United States

St. Joseph's Hospital

Liverpool, New York, United States

NYU Langone

New York, New York, United States

NC Heart

Raleigh, North Carolina, United States

Mt Carmel

Columbus, Ohio, United States

UPMC Hamot

Erie, Pennsylvania, United States

Temple University Hospital

Philadelphia, Pennsylvania, United States

UPMC Heart and Vascular Institute

Pittsburgh, Pennsylvania, United States

Tennova Heart - Turkey Creek

Knoxville, Tennessee, United States

CAMC

Charleston, West Virginia, United States

Countries

United States

References

Bashir R, Foster M, Iskander A, Darki A, Jaber W, Rali PM, Lakhter V, Gandhi R, Klein A, Bhatheja R, Ross C, Natarajan K, Nanjundappa A, Angle JF, Ouriel K, Amoroso NE, Firth BG, Comerota AJ, Piazza G, Rosenfield K, Sista AK. Pharmacomechanical Catheter-Directed Thrombolysis With the Bashir Endovascular Catheter for Acute Pulmonary Embolism: The RESCUE Study. JACC Cardiovasc Interv. 2022 Dec 12;15(23):2427-2436. doi: 10.1016/j.jcin.2022.09.011. Epub 2022 Sep 17.

Reference Type: DERIVED

PMID: 36121244 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

THRO-CLIN-2019-01

Identifier Type: -

Identifier Source: org_study_id