Conditions: Pulmonary Embolism Acute Pulmonary Embolism Sub-massive Pulmonary Embolism Massive Pulmonary Embolism Pulmonary Thromboembolism
Keywords: Fibrinolysis catheter directed fibrinolysis ultrasound accelerated fibrinolysis recombinant t-PA Activase
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 150
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine if the EKOS EkoSonic® Endovascular Device when used in conjunction with recombinant tissue plasminogen activator (t-PA) as a treatment for acute PE will decrease the ratio of right ventricle (RV) to left ventricle (LV) diameter within 48 =/- 6 hours in participants with massive or submassive PE.

Detailed description:

Arms:
arm 1: 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.

Interventions: intervention 1: recombinant tissue plasminogen activator intervention 2: EKOS EkoSonic Endovascular System
Intervention descriptions: intervention 1: Participants will receive 24 mg of r-tPA delivered via the EkoSonic Endovascular Device. intervention 2: 24 mg of r-tPA will be delivered through the EkoSonic Endovascular System.

Protocol document: