Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01166997 | ULTrasound Accelerated ThrombolysIs of PulMonAry Embolism | PHASE3 | COMPLETED | 59 | — | — | Jul 1, 2010 | May 1, 2013 | Jul 19, 2021 | 10 | Germany, Switzerland |
Change in the end-diastolic RV/LV ratio from baseline to 24 hours by echocardiography.
Bleeding will be classified as major if it is associated with a fall in the hemoglobin level of at least 2.0 g/dl, transfusion of ≥ 2 units of red blood cells, or involvement of a critical site (e.g., intracranial, intraspinal). To aid in evaluating the relationship of bleeding events to rt-PA administration, they will also be categorized by whether they occurred within 3 days after the initiation of thrombolytic therapy.
| Arm | Type | Description |
|---|---|---|
| Ultrasound accelerated thrombolysis | EXPERIMENTAL | 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. |
| Intravenous unfractionated heparin | ACTIVE_COMPARATOR | Patients in this arm will receive the standard of care: intravenous unfractionated heparin used as anti-coagulation treatment. |
| Name | Type | Description |
|---|---|---|
| EkoSonic Endovascular System | DEVICE | The EkoSonic Endovascular System will be used to deliver \< 20 mg of rt-PA ( Actilyse) directly into the occlusive pulmonary thrombus. |
| Unfractionated heparin | DRUG | Intravenous unfractionated heparin used for anticoagulation treatment |
Inclusion Criteria: * Patients with acute PE symptoms \< 14 days. * Filling defect by contrast-enhanced chest CT in at least one main or proximal lower lobe pulmonary artery * Right ventricular dysfunction confirmed by echocardiography where the RV/LV end diastolic diameter ratio is ≥ 1.0. Exclusi...