ULTrasound Accelerated ThrombolysIs of PulMonAry Embolism

Phase 3 Completed 59 enrolled Boston Scientific Corporation EKOS Corporation · collab

RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start: 2010-07
Primary completion: 2013-04
Completion: 2013-05

Publications

Kucher N, Boekstegers P, Muller OJ, Kupatt C, Beyer-Westendorf J, Heitzer T, Tebbe U, Horstkotte J, Muller R, Blessing E, Greif M, Lange P, Hoffmann RT, Werth S, Barmeyer A, Hartel D, Grunwald H, Empen K, Baumgartner I. Randomized, controlled trial of ultrasound-assisted catheter-directed thrombolysis for acute intermediate-risk pulmonary embolism. Circulation. 2014 Jan 28;129(4):479-86. doi: 10.1161/CIRCULATIONAHA.113.005544. Epub 2013 Nov 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Heparin	Other / unclassified	—	Intravenous

Indications

No indication recorded.