ULTrasound Accelerated ThrombolysIs of PulMonAry Embolism (ULTIMA)
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ClinicalTrials.gov Identifier: NCT01166997 |
Recruitment Status :
Completed
First Posted : July 21, 2010
Results First Posted : October 18, 2016
Last Update Posted : July 19, 2021
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Condition or disease | Intervention/treatment | Phase |
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Submassive Pulmonary Embolism | Device: EkoSonic Endovascular System Drug: Unfractionated heparin | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 59 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Randomized, Controlled Study Comparing EKOS EkoSonic Ultrasound Accelerated Thrombolysis to Anticoagulation in the Treatment of Sub-massive Pulmonary Embolism |
Study Start Date : | July 2010 |
Actual Primary Completion Date : | April 2013 |
Actual Study Completion Date : | May 2013 |

Arm | Intervention/treatment |
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Experimental: Ultrasound accelerated thrombolysis
Patients in this arm will receive anti-coagulation (intravenous unfractionated heparin) plus the EkoSonic Endovascular System will be used to deliver a low dose <20mg rt-PA (Actilyse) directly into the occlusive pulmonary thrombus.
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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. |
Active Comparator: Intravenous unfractionated heparin
Patients in this arm will receive the standard of care: intravenous unfractionated heparin used as anti-coagulation treatment.
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Drug: Unfractionated heparin
Intravenous unfractionated heparin used for anticoagulation treatment |
- Reduction of RV/LV Ratio [ Time Frame: 24 hours ]Change in the end-diastolic RV/LV ratio from baseline to 24 hours by echocardiography.
- Major Bleeding and Intracranial Bleeding at 30 Days. [ Time Frame: 30 days ]Bleeding will be classified as major if it is associated with a fall in the hemoglobin level of at least 2.0 g/dl, transfusion of ≥ 2 units of red blood cells, or involvement of a critical site (e.g., intracranial, intraspinal). To aid in evaluating the relationship of bleeding events to rt-PA administration, they will also be categorized by whether they occurred within 3 days after the initiation of thrombolytic therapy.

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with acute PE symptoms < 14 days.
- Filling defect by contrast-enhanced chest CT in at least one main or proximal lower lobe pulmonary artery
- Right ventricular dysfunction confirmed by echocardiography where the RV/LV end diastolic diameter ratio is ≥ 1.0.
Exclusion Criteria:
- Age less than 18 years or greater than 80 years
- Index PE symptom duration > 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 < 100 000/mm3, or previous use of vitamin K antagonists with INR > 2.5
- History of any intracranial or intraspinal surgery or trauma or intracranial/intraspinal bleed
- Intracranial neoplasm, arteriovenous malformation, or aneurysm
- Recent (< 3 months) GI bleeding.
- Recent (< 3 months) internal eye surgery or hemorrhagic retinopathy; recent (< 10 days) major surgery, cataract surgery, trauma, CPR, obstetrical delivery, or other invasive procedure.
- Allergy, hypersensitivity, or thrombocytopenia from heparin, rt-PA, or iodinated contrast, except for mild-moderate contrast allergies for which steroid pre-medication can be used.
- Estimated glomerular filtration rate (eGFR) < 50 ml/min as calculated by the Cockroft formula.
- Hemodynamic collapse at presentation defined as: need for cardiopulmonary resuscitation; or systolic blood pressure < 90 mm Hg for at least 15 min, or drop of systolic blood pressure by at least 40 mm Hg for at least 15 min with signs of end organ hypoperfusion (cold extremities or low urinary output < 30 mL/h or mental confusion); or need for catecholamine administration to maintain adequate organ perfusion and a systolic blood pressure of > 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 < 90 days.
- Inability to comply with study assessments (e.g. due to geographic distance).
- Previous enrollment in this study
- Any other condition that the investigator feels would place the patient at increased risk if the investigational therapy is initiated.
- Known right-to-left shunt, for example from large patent foramen ovale or atrial septal defect
- Large (>10 mm) right atrial or right ventricular thrombus

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01166997
Germany | |
Klinikum Lippe-Detmold | |
Detmold, Germany, 32756 | |
Klinikum Dortmund gGmbH | |
Dortmund, Germany, 44137 | |
Universitätsklinikum Carl Gustav Carus an der TU Dresden | |
Dresden, Germany, 01307 | |
Universitätsklinikum der Ernst-Moritz-Arndt-Universität, | |
Greifswald, Germany, 17475 | |
Universitätsklinikum Heidelberg | |
Heidelberg, Germany, 69120 | |
Klinikum der Ludwig-Maximilians-Universität (LMU) | |
München, Germany, 81377 | |
Christliches Krankenhaus Quakenbrueck | |
Quakenbrueck, Germany, 49610 | |
Helios Klinikum Siegburg | |
Siegburg, Germany, 53721 | |
SRH Zentralklinikum Suhl | |
Suhl, Germany, 98527 | |
Switzerland | |
Inselspital Bern, Kliniken fur Kardiologie and Angiologie | |
Bern, Switzerland, 3010 |
Principal Investigator: | Nils Kucher, Prof Dr med | Inselspital Bern, Kliniken für Angiologie und Kardiologie |
Responsible Party: | Boston Scientific Corporation |
ClinicalTrials.gov Identifier: | NCT01166997 |
Other Study ID Numbers: |
EKOS Protocol Number 08 |
First Posted: | July 21, 2010 Key Record Dates |
Results First Posted: | October 18, 2016 |
Last Update Posted: | July 19, 2021 |
Last Verified: | July 2021 |
Pulmonary embolism Pulmonary thromboembolism anticoagulation thrombolysis ultrasound accelerated thrombolysis |
Pulmonary Embolism Embolism Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases |
Heparin Calcium heparin Anticoagulants Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action |