The EKOS™ Endovascular System is the most studied device in the pulmonary embolism space.

The ULTIMA Trial

EKOS Endovascular System
PE Clinical Studies

The ULTIMA trial is the first (and only) head-to-head prospective, randomized-controlled trial that showed EKOS is more effective than anticoagulation alone and just as safe. This controlled trial of ultrasound-assisted catheter-directed thrombolysis for acute intermediate-risk Pulmonary Embolism was done in 2014.

Nils Kucher, MD et al. Circulation 2014; 129: 479-486

Clinical significance

The only level 1 data

for interventional treatment of PE

Reduction 23% RV/LV ratio

(P<0.001) in 24 hours

The 1st head-to-head

RCT against standard of care.

0 ICH and 0% major bleed

59 patients in 8 centres

Trial overview

  • Prospective, multi-center, randomised, controlled trial
  • 59 patients with acute intermediate-risk PE
  • 8 centers in Germany and Switzerland
  • Infusion time: 15 hours. Total dose: 20 mg
  • 23% reduction (p<0.001) in RV/LV ratio from baseline vs. 2.5% (p=.031) in Heparin group
  • No major bleeds, deaths or recurrent VTE at 90 days
  • 0 ICH


The ULTIMA Trial 1.jpg
The ULTIMA Trial 1.jpg
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Key results

  • RV/LV ratio significantly improved at 24 hours.
  • Reduction in RV/LV ratio significantly greater at 24 hours and improved at 90 days.
  • No deaths or significant bleeding complications.
  • Systolic RV dysfunction significantly improved.

RV/LV Ratio Significantly
Improved at 24 Hours

ULTIMA trial RV-LV Ratio 24 hours

Reduction in RV/LV Ratio
Greater at 24 Hours and Improved at 90 days

ULTIMA trial RV-LV Ratio 24 hours

Systolic RV Dysfunction
Significantly improved

ULTIMA trial Systolic RV Dysfunction

No Deaths or Significant Bleeding Complications

Clinical outcomes at 90 daysEKOS with tPA + Heparin N = 30Heparin N = 29P-value
Recurrent venous thromboembolism00%00%1
Major bleeding00%00%1
Major bleeding3**10%13%0.61

*Rehospitalisation and death from advanced pancreatic cancer

**Two patients with transient mild hemoptysis without medical intervention, one patient with groin hematoma requiring manual compression

✞One patient with transient anal bleeding following endoscopic removal of colon polyp

Trial conclusions

The ULTIMA trial showed that a fixed-dose EKOS regimen was superior to anticoagulation alone in improving right ventricular dysfunction at 24 hours without an increase in bleeding complications.

Trial bibliography

2014 - ULTIMA: Randomised, Controlled Trial of Ultrasound-Assisted Catheter-Directed Thrombolysis for Acute Intermediate-Risk Pulmonary Embolism

Nils Kucher, MD et al. Circulation 2014; 129: 479-486

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