Acute Submassive Pulmonary Embolism Clinical Trial
Official title:
Recombinant tPA by Endovascular Pulse Administration for the Treatment of Submassive Pulmonary Embolism Using Pharmaco-mechanical Catheter Directed Thrombolysis for the redUction of Thrombus burdEn
To demonstrate the efficacy and safety of the Bashir™ Endovascular Catheter for the administration of pharmaco-mechanical catheter directed therapy using pulse spray of r-tPA for the treatment of acute submassive pulmonary embolism
Study Objective To demonstrate the efficacy and safety of the Bashir™ and Bashir™ S-B Endovascular Catheters for the administration of pharmaco- mechanical catheter directed therapy in a pulse spray mode using low dose r-tPA for the treatment of acute submassive pulmonary embolism. Endpoints Primary Efficacy Endpoint Reduction in RV/LV diameter ratio as measured by CTA within 48 hours after the completion of r-tPA treatment. Primary Safety Endpoint Major bleeding, as defined by International Society of Thrombosis and Hemostasis (ISTH), within 72 hours of initiation of r- tPA infusion. ISTH major bleeding in non-surgical patients is defined as having a symptomatic presentation and: a. Fatal bleeding; and/or b. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra- articular or pericardial, or intramuscular with compartment syndrome; and/or c. Bleeding causing a fall in hemoglobin level of 2.0g/dL (1.24mmol/L) or more or leading to transfusion of two or more units of whole blood or red cells. Secondary Endpoints 1. Refined Modified Miller Score as measured on CTA within 48 hours after the completion of the r-tPA infusion compared to baseline as measured by core lab. 25 2. All-cause mortality at hospital discharge through 30-day follow-up. 3. SAEs through 30-day follow-up. 4. AEs through 30-day follow-up. 5. UADEs through 30-day follow-up. 6. Recurrent PE through 30-day follow-up. 7. Clinically Relevant Non-Major bleeding: Any sign or symptom of hemorrhage (e.g. more bleeding than would be expected for a clinical circumstance, including bleeding found by imaging alone) that does not fit the criteria for the ISTH definition of major bleeding but does meet at least one of the following criteria: 1. Requiring medical intervention by a healthcare professional. 2. Leading to hospitalization or increased level of care. 3. Prompting a face to face (i.e., not just a telephone or electronic communication) evaluation. 8. Technical procedural complications. 9. Systolic PA pressure measured at completion of pulse sprays and after BEC(s) removal and compared to baseline. 10. Cardiac output (CO by Modified Fick calculation) and cardiac index (CI) following completion of the r-tPA pulse sprays compared to the baseline. Please refer to Terms and Definitions section for the Modified Fick calculation to be done in the IR suite / cath lab at baseline and after BEC removal). ;