Conditions: Submassive Pulmonary Embolism
Keywords: Pulmonary embolism Pulmonary thromboembolism anticoagulation thrombolysis ultrasound accelerated thrombolysis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 59
Healthy volunteers: no

Brief summary:
The ULTIMA study is intended to prove that in patients with pulmonary embolism and a right ventricular end diastolic diameter to left ventricular end diastolic diameter ratio ≥1 (RV/LV ratio) will benefit from treatment with ultrasound accelerated thrombolysis (rt-PA) as compared to unfractionated heparin anticoagulation. Specifically, at 24 hours the RV/LV ratio will be significantly reduced in the treatment arm compared to the control arm.

Detailed description:

Arms:
arm 1: Patients in this arm will receive anti-coagulation (intravenous unfractionated heparin) plus the EkoSonic Endovascular System will be used to deliver a low dose \<20mg rt-PA (Actilyse) directly into the occlusive pulmonary thrombus. arm 2: Patients in this arm will receive the standard of care: intravenous unfractionated heparin used as anti-coagulation treatment.

Interventions: intervention 1: EkoSonic Endovascular System intervention 2: Unfractionated heparin
Intervention descriptions: intervention 1: The EkoSonic Endovascular System will be used to deliver \< 20 mg of rt-PA ( Actilyse) directly into the occlusive pulmonary thrombus. intervention 2: Intravenous unfractionated heparin used for anticoagulation treatment

Protocol document: