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

Primary Purpose

Pulmonary Embolism

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
The Bashir™ Endovascular Catheter
r-tPA
Sponsored by
Thrombolex, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Embolism focused on measuring Pulmonary Embolism, Catheter Directed Therapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UCLA
  • Miami Cardiac & Vascular Institute
  • Advent Health Orlando
  • Emory
  • Piedmont Heart Institute
  • Loyola University Chicago
  • Ascension St. Vincent
  • Ascension St. John Hospital
  • Beaumont Hospital, Royal Oak
  • University of Minnesota
  • St. Joseph's Hospital
  • NYU Langone
  • NC Heart
  • Mt Carmel
  • UPMC Hamot
  • Temple University Hospital
  • UPMC Heart and Vascular Institute
  • Tennova Heart - Turkey Creek
  • CAMC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BEC Treatment

Arm Description

The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery.

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

Full Information

First Posted
January 28, 2020
Last Updated
March 29, 2023
Sponsor
Thrombolex, Inc.
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT04248868
Brief Title
tPA by Endovascular Administration for the Treatment of Submassive PE Using CDT for the Reduction of Thrombus Burden
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
June 23, 2020 (Actual)
Primary Completion Date
June 22, 2022 (Actual)
Study Completion Date
June 23, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thrombolex, Inc.
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Embolism
Keywords
Pulmonary Embolism, Catheter Directed Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
Pulse Spray and Infusion of r-tPA
Masking
None (Open Label)
Allocation
N/A
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BEC Treatment
Arm Type
Experimental
Arm Description
The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery.
Intervention Type
Device
Intervention Name(s)
The Bashir™ Endovascular Catheter
Intervention Description
The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery and peripheral vasculature.
Intervention Type
Drug
Intervention Name(s)
r-tPA
Intervention Description
Pulse spray and infusion
Primary Outcome Measure Information:
Title
Efficacy: RV/LV Ratio Difference
Description
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).
Time Frame
48 hours after the completion of r-tPA treatment
Title
Safety: Major Bleeding
Description
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.
Time Frame
Within 72 hours of initiation of r-tPA administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Willing and able to provide informed consent; Age 18 to ≤ 75 years of age; PE symptom duration ≤ 14 days. Filling defect in at least one main or lobar pulmonary artery as determined by contrast enhanced chest CT (CTA); RV/LV diameter ratio ≥ 0.9 by CTA as determined by the investigative site; Willing and able to comply with all study procedures and follow-up. Exclusion Criteria: CVA or TIA within one (1) year; Head trauma, active intracranial, or intraspinal disease ≤ one (1) year prior to inclusion in the study; Active bleeding from a major organ within one (1) month prior to inclusion in the study; Intracranial condition(s) that may increase the risk of bleeding (e.g., neoplasms, arteriovenous malformations, or aneurysms); Patients with bleeding diatheses; Hematocrit < 30%; Platelets < 100,000/μL; INR > 1.5 if currently on warfarin (Coumadin®); aPTT > 50 seconds in the absence of anticoagulants; Major surgery ≤ 14 days prior to inclusion in the study; Serum creatinine > 2.0mg/dL; Clinician deems high-risk for catastrophic bleeding; History of heparin-induced thrombocytopenia (HIT Syndrome); Pregnancy; SBP < 90 mmHg > 15 minutes within two (2) hours prior to BEC procedure and is not resolved with IV fluids; Any vasopressor support; Cardiac arrest (including pulseless electrical activity and asystole) requiring active cardiopulmonary resuscitation (CPR) during this hospitalization at treating institution and/or referring institution; Evidence of irreversible neurological compromise; Life expectancy < one (1) year; Use of thrombolytics or glycoprotein IIb/IIIa inhibitor within 3 days prior to inclusion in the study; 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; Profound bradycardia requiring a temporary pacemaker and/or inotropic support; Previous enrollment in this study; Morbidly obese patient who by the judgement of the investigator is high risk for bleeding; BMI > 45kg/m2; Absolute contraindication to anticoagulation; Uncontrolled hypertension defined as SBP > 175mmHg and / or DBP > 110mmHg with pharmacotherapy within two (2) hours prior to inclusion in the study; Currently participating in another study; Any arterial line placement; 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; In the opinion of the investigator, the subject is not a suitable candidate for the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Firth, MD, PhD, MBA, FACC
Organizational Affiliation
Thrombolex, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Miami Cardiac & Vascular Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Advent Health Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Emory
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Piedmont Heart Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Loyola University Chicago
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60521
Country
United States
Facility Name
Ascension St. Vincent
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Ascension St. John Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Beaumont Hospital, Royal Oak
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
St. Joseph's Hospital
City
Liverpool
State/Province
New York
ZIP/Postal Code
13088
Country
United States
Facility Name
NYU Langone
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
NC Heart
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Mt Carmel
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
UPMC Hamot
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16550
Country
United States
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19122
Country
United States
Facility Name
UPMC Heart and Vascular Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Tennova Heart - Turkey Creek
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37934
Country
United States
Facility Name
CAMC
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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