Pulmonary Embolism Clinical Trial
— RESCUEOfficial 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
Verified date | March 2023 |
Source | Thrombolex, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Thrombolex, Inc. | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
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 |
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