This is an experimental research study of a device sponsored 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: Assess safety during the procedure and through 30 days following the procedure. Assess 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. Determine if the study device can be used as intended.
This study is currently enrolling.