Phase 3
N=59
ULTrasound Accelerated ThrombolysIs of PulMonAry Embolism
Submassive Pulmonary Embolism
Bottom Line
View on ClinicalTrials.gov: NCT01166997 ↗Enrolled (actual)
59
Serious AEs
11.9%
Results posted
Oct 2016
Primary outcome: Primary: Reduction of RV/LV Ratio — 0.03; 0.30 Ratio
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- EkoSonic Endovascular System (Device); Unfractionated heparin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston Scientific Corporation
- Primary completion
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reduction of RV/LV Ratio |
0.03; 0.30 | — |
| PRIMARY Major Bleeding and Intracranial Bleeding at 30 Days. |
0; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Patients with acute PE symptoms 14 days
- Insufficient echocardiographic image quality in the apical or subcostal four-chamber view that prohibits the measurement of the right and left ventricular end-diastolic dimensions
- Known significant bleeding risk
- Administration of thrombolytic agents, e.g., tissue plasminogen activator, streptokinase, or urokinase, within the previous 4 days
- Active bleeding
- Known bleeding diathesis
- Known coagulation disorder, platelet count 2.5
- History of any intracranial or intraspinal surgery or trauma or intracranial/intraspinal bleed
- Intracranial neoplasm, arteriovenous malformation, or aneurysm
- Recent ( 90 mm Hg.
- Severe hypertension on repeated readings (systolic > 180 mmHg or diastolic > 105 mmHg).
- Pregnant, lactation or parturition within the previous 30 days (positive pregnancy test, women of childbearing age must be tested).
- Participating in any other investigational drug or device study.
- Life expectancy 10 mm) right atrial or right ventricular thrombus
Data sourced from ClinicalTrials.gov (NCT01166997). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.