| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01513759 | Submassive and Massive Pulmonary Embolism Treatment With Ultrasound Accelerated Thrombolysis Therapy | PHASE3 | COMPLETED | 150 | — | — | Jun 7, 2012 | Feb 17, 2013 | Jul 19, 2021 | 22 | United States |
Change from baseline in RV diameter/LV diameter ratio was determined by contrast-enhanced chest computed tomography (CT) within 48 +/- 6 hours after initiating ultrasound-accelerated catheter-directed fibrinolysis.
Bleeding adverse events were graded (severe or life-threatening, moderate or mild bleeding) according to the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) classification. The participant incidence of major bleeding events was defined as GUSTO moderate and severe events occurring within 72 hours after starting the ultrasound-accelerated catheter-directed fibrinolysis procedure. Mild: Does not meet criteria for moderate or severe; Moderate: Requires transfusion - No hemodynamic compromise; and Severe: Bleeding causes hemodynamic compromise and required intervention or intracranial hemorrhage. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
| Arm | Type | Description |
|---|---|---|
| EkoSonic® Endovascular System | EXPERIMENTAL | Participants will receive a total of 24 milligrams (mg) of recombinant t-PA infusion, at an infusion rate of 1 milligrams/hour (mg/hr) per device (2 mg/hour for bilateral PE) delivered through the EkoSonic® Endovascular System. This regimen allows for a recombinant t-PA infusion time of 24 hours for one catheter and 12 hours for two catheters, respectively. |
| Name | Type | Description |
|---|---|---|
| recombinant tissue plasminogen activator | DRUG | Participants will receive 24 mg of r-tPA delivered via the EkoSonic Endovascular Device. |
| EKOS EkoSonic Endovascular System | DEVICE | 24 mg of r-tPA will be delivered through the EkoSonic Endovascular System. |
Inclusion Criteria: * Computed tomography (CT) evidence of proximal PE (filling defect in at least one main or segmental pulmonary artery) * PE symptom duration less than or equal to (\<=)14 days * Informed consent can be obtained from participant or Legally Authorized Representative (LAR) * Massiv...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| ICON Plc | ICLR | 1 | NA | Undisclosed |
| Penumbra, Inc. | PEN | 1 | — | Undisclosed |
| Boston Scientific Corporation | BSX | 1 | — | Undisclosed |
| AngioDynamics, Inc. | ANGO | 2 | NA | Undisclosed |
| Universidade do Porto | OSTX | 1 | — | Undisclosed |