Recombinant tPA by Endovascular Administration for the treatment of Submassive pulmonary embolism using pharmaco-mechanical Catheter directed thrombolysis for the reduction of thrombus burden (RESCUE study)

Brief description of study

This is an experimental research study of a device manufactured by Thrombolex, Inc., (the study sponsor). The study device is for the treatment of a sudden, large, blood clot in the lung(s). The purpose of this study is to demonstrate proof of efficacy and safety of the Bashirâ„¢ Endovascular Catheter for the administration of low dose r-tPA for the treatment of acute submassive pulmonary embolism (the large blood clot in your lung(s)). The study will also assess safety during the procedure and through 30 days following the procedure. In addition, the study will also examine if major bleeding occurs within 72 hours of receiving a medication called r-tPA. This medication is already FDA approved for administration at a much larger dose by IV for your condition than is planned in this study. This drug works by dissolving clots and improving blood flow.

Clinical Study Identifier: s20-00358 Identifier: NCT04248868
Principal Investigator: Nancy E Amoroso.

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