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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
Sponsor:
Collaborator:
EKOS Corporation
Information provided by (Responsible Party):
Boston Scientific Corporation

Tracking Information
First Submitted Date  ICMJE July 15, 2010
First Posted Date  ICMJE July 21, 2010
Results First Submitted Date  ICMJE August 23, 2016
Results First Posted Date  ICMJE October 18, 2016
Last Update Posted Date July 19, 2021
Study Start Date  ICMJE July 2010
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 24, 2016)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 20, 2010)
Reduction of RV/LV Ratio [ Time Frame: 24 hours ]
RV/LV ratio will be measured by echocardiography at baseline. RV/LV ratio will be measured again by echocardiography at 24 hours.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ULTrasound Accelerated ThrombolysIs of PulMonAry Embolism
Official Title  ICMJE Randomized, Controlled Study Comparing EKOS EkoSonic Ultrasound Accelerated Thrombolysis to Anticoagulation in the Treatment of Sub-massive Pulmonary Embolism
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Submassive Pulmonary Embolism
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Device: EkoSonic Endovascular System
  • Active Comparator: Intravenous unfractionated heparin
    Patients in this arm will receive the standard of care: intravenous unfractionated heparin used as anti-coagulation treatment.
    Intervention: Drug: Unfractionated heparin
Publications * Kucher N, Boekstegers P, Müller OJ, Kupatt C, Beyer-Westendorf J, Heitzer T, Tebbe U, Horstkotte J, Müller R, Blessing E, Greif M, Lange P, Hoffmann RT, Werth S, Barmeyer A, Härtel D, Grünwald 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 11, 2013)
59
Original Estimated Enrollment  ICMJE
 (submitted: July 20, 2010)
50
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01166997
Other Study ID Numbers  ICMJE EKOS Protocol Number 08
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boston Scientific Corporation
Study Sponsor  ICMJE Boston Scientific Corporation
Collaborators  ICMJE EKOS Corporation
Investigators  ICMJE
Principal Investigator: Nils Kucher, Prof Dr med Inselspital Bern, Kliniken für Angiologie und Kardiologie
PRS Account Boston Scientific Corporation
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP