NCT01166997

ULTrasound Accelerated ThrombolysIs of PulMonAry Embolism

Randomized, Controlled Study Comparing EKOS EkoSonic Ultrasound Accelerated Thrombolysis to Anticoagulation in the Treatment of Sub-massive Pulmonary Embolism

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Submassive Pulmonary Embolism

Interventions

Type	Name	Description
DEVICE	EkoSonic Endovascular System	The EkoSonic Endovascular System will be used to deliver \< 20 mg of rt-PA ( Actilyse) directly into the occlusive pulmonary thrombus.
DRUG	Unfractionated heparin	Intravenous unfractionated heparin used for anticoagulation treatment

Timeline

• Start date: 2010-07-01
• Primary completion: 2013-04-01
• Completion: 2013-05-01
• First posted: 2010-07-21
• Last updated: 2021-07-19
• Results posted: 2016-10-18

Locations

10 sites across 2 countries: Germany, Switzerland