Submassive and Massive Pulmonary Embolism Treatment With Ultrasound Accelerated Thrombolysis Therapy

Completed · Phase 3

Conditions studied: Pulmonary Embolism, Acute Pulmonary Embolism, Sub-massive Pulmonary Embolism, Massive Pulmonary Embolism, Pulmonary Thromboembolism

In brief

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.

Key facts

Study ID

NCT01513759

Run by

Boston Scientific Corporation

People needed

150

Starts

2012-06-07

Expected to finish

2013-02-17

Last updated by the study team

2021-07-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Computed tomography (CT) evidence of proximal PE (filling defect in at least one main or 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 resuscitated cardiac arrest) or
• Submassive PE (RV diameter-to-LV diameter greater than or equal to [>=] 0.9 on contrast-enhanced chest CT)

You may not qualify if…

• Stroke or transient ischemic attack (TIA), head trauma, or other active intracranial or 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 of study enrollment
• Systolic blood pressure less than 80 mm Hg despite vasopressor or inotropic support
• Cardiac arrest (including pulseless electrical activity and asystole) requiring active cardiopulmonary resuscitation (CPR)
• Evidence of irreversible neurological compromise
• Life expectancy <30 days
• Use of thrombolytics or glycoprotein IIb/IIIa antagonists within 3 days prior to inclusion in the study
• Previous enrollment in the SEATTLE study

Where it is running

• Baptist Health — Montgomery, Alabama, United States
• Memorial Medical Center — Modesto, California, United States
• Stanford University Medical Center — Stanford, California, United States
• Hartford Hospital — Hartford, Connecticut, United States
• Christiana Hospital — Newark, Delaware, United States
• Lakeland Regional Medical Center — Lakeland, Florida, United States
• Holmes Regional Medical Center — Melbourne, Florida, United States
• Florida Hospital — Orlando, Florida, United States
• Orlando Regional Medical Center — Orlando, Florida, United States
• Medical Center of Central Georgia — Macon, Georgia, United States
• Prairie Heart Institute — Springfield, Illinois, United States
• St. Vincent Hospital — Indianapolis, Indiana, United States
• University of Kentucky, Gill Heart Institute — Lexington, Kentucky, United States
• East Jefferson General Hospital — New Orleans, Louisiana, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Overlook Medical Center — Morristown, New Jersey, United States
• Holy Name Hospital — Teaneck, New Jersey, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Mt. Carmel East — Columbus, Ohio, United States
• The Miriam Hospital — Providence, Rhode Island, United States
• Providence Memorial and Sierra Medical Center — El Paso, Texas, United States
• Inova Alexandria Hospital — Alexandria, Virginia, United States

Full record on ClinicalTrials.gov

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