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

Pulmonary Embolism Clinical Trial

— RESCUE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04248868
• Other study ID #: THRO-CLIN-2019-01
• Status: Completed
• Phase: Phase 3
• Start date: June 23, 2020
• Est. completion date: June 23, 2022

Study information

• Verified date: March 2023
• Source: Thrombolex, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: June 23, 2022
• Est. primary completion date: June 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Intervention

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

Locations

Country	Name	City	State
United States	Emory	Atlanta	Georgia
United States	Piedmont Heart Institute	Atlanta	Georgia
United States	CAMC	Charleston	West Virginia
United States	Mt Carmel	Columbus	Ohio
United States	Ascension St. John Hospital	Detroit	Michigan
United States	UPMC Hamot	Erie	Pennsylvania
United States	Ascension St. Vincent	Indianapolis	Indiana
United States	Tennova Heart - Turkey Creek	Knoxville	Tennessee
United States	St. Joseph's Hospital	Liverpool	New York
United States	UCLA	Los Angeles	California
United States	Loyola University Chicago	Maywood	Illinois
United States	Miami Cardiac & Vascular Institute	Miami	Florida
United States	University of Minnesota	Minneapolis	Minnesota
United States	NYU Langone	New York	New York
United States	Advent Health Orlando	Orlando	Florida
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	UPMC Heart and Vascular Institute	Pittsburgh	Pennsylvania
United States	NC Heart	Raleigh	North Carolina
United States	Beaumont Hospital, Royal Oak	Royal Oak	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Thrombolex, Inc.	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy: RV/LV Ratio Difference	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).	48 hours after the completion of r-tPA treatment
Primary	Safety: Major Bleeding	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.	Within 72 hours of initiation of r-tPA administration