Submassive and Massive Pulmonary Embolism Treatment With Ultrasound Accelerated Thrombolysis Therapy

Last updated: July 15, 2021
Sponsor: Boston Scientific Corporation
Overall Status: Completed

Phase

3

Condition

Pulmonary Embolism

Blood Clots

Thrombosis

Treatment

EKOS EkoSonic Endovascular System

recombinant tissue plasminogen activator

Clinical Study ID

NCT01513759
EKOS 09
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to determine if the EKOS EkoSonic® Endovascular Device when used in conjunction with recombinant tissue plasminogen activator (t-PA) as a treatment for acute PE will decrease the ratio of right ventricle (RV) to left ventricle (LV) diameter within 48 =/- 6 hours in participants with massive or submassive PE.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Computed tomography (CT) evidence of proximal PE (filling defect in at least one mainor segmental pulmonary artery)
  • PE symptom duration less than or equal to (<=)14 days
  • Informed consent can be obtained from participant or Legally Authorized Representative (LAR)
  • Massive PE (syncope, systemic arterial hypotension, cardiogenic shock, or resuscitatedcardiac arrest) or
  • Submassive PE (RV diameter-to-LV diameter greater than or equal to [>=] 0.9 oncontrast-enhanced chest CT)

Exclusion

Exclusion Criteria:

  • Stroke or transient ischemic attack (TIA), head trauma, or other active intracranialor intraspinal disease within one year
  • Recent (within one month) or active bleeding from a major organ
  • Hematocrit less than (<) 30 percent (%)
  • Platelets < 100 thousand/microliter (mcL)
  • International Normalized Ratio (INR) greater than (>) 3
  • Activated partial thromboplastin time (aPTT) >50 seconds on no anticoagulants
  • Major surgery within seven days of screening for study enrollment
  • Serum creatinine >2 milligrams/deciliter (mg/dL)
  • Clinician deems high-risk for catastrophic bleeding
  • History of heparin-induced thrombocytopenia (HIT)
  • Pregnancy
  • Catheter-based pharmacomechanical treatment for pulmonary embolism within 3 days ofstudy enrollment
  • Systolic blood pressure less than 80 mm Hg despite vasopressor or inotropic support
  • Cardiac arrest (including pulseless electrical activity and asystole) requiring activecardiopulmonary resuscitation (CPR)
  • Evidence of irreversible neurological compromise
  • Life expectancy <30 days
  • Use of thrombolytics or glycoprotein IIb/IIIa antagonists within 3 days prior toinclusion in the study
  • Previous enrollment in the SEATTLE study

Study Design

Total Participants: 150
Treatment Group(s): 2
Primary Treatment: EKOS EkoSonic Endovascular System
Phase: 3
Study Start date:
June 07, 2012
Estimated Completion Date:
February 17, 2013

Connect with a study center

  • Baptist Health

    Montgomery, Alabama 36116
    United States

    Site Not Available

  • Memorial Medical Center

    Modesto, California 95355
    United States

    Site Not Available

  • Stanford University Medical Center

    Stanford, California 94305
    United States

    Site Not Available

  • Hartford Hospital

    Hartford, Connecticut
    United States

    Site Not Available

  • Yale-New Haven Hospital

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Christiana Hospital

    Newark, Delaware 19718
    United States

    Site Not Available

  • Lakeland Regional Medical Center

    Lakeland, Florida 33805
    United States

    Site Not Available

  • Holmes Regional Medical Center

    Melbourne, Florida 32901
    United States

    Site Not Available

  • Florida Hospital

    Orlando, Florida 32803
    United States

    Site Not Available

  • Orlando Regional Medical Center

    Orlando, Florida 32806
    United States

    Site Not Available

  • Medical Center of Central Georgia

    Macon, Georgia 31201
    United States

    Site Not Available

  • Prairie Heart Institute

    Springfield, Illinois 62701
    United States

    Site Not Available

  • St. Vincent Hospital

    Indianapolis, Indiana
    United States

    Site Not Available

  • University of Kentucky, Gill Heart Institute

    Lexington, Kentucky 40536
    United States

    Site Not Available

  • East Jefferson General Hospital

    New Orleans, Louisiana 70006
    United States

    Site Not Available

  • Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Overlook Medical Center

    Morristown, New Jersey 07960
    United States

    Site Not Available

  • Holy Name Hospital

    Teaneck, New Jersey 07666
    United States

    Site Not Available

  • Montefiore

    Bonx, New York
    United States

    Site Not Available

  • Montefiore Medical Center

    Bronx, New York 10467
    United States

    Site Not Available

  • Mt. Carmel East

    Columbus, Ohio 43213
    United States

    Site Not Available

  • The Reading Hospital and Medical Center

    East Reading, Pennsylvania 19611
    United States

    Site Not Available

  • The Miriam Hospital

    Providence, Rhode Island 02906
    United States

    Site Not Available

  • Providence Memorial and Sierra Medical Center

    El Paso, Texas 79902
    United States

    Site Not Available

  • Inova Alexandria Hospital

    Alexandria, Virginia 22304
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.