Submassive and Massive Pulmonary Embolism Treatment With Ultrasound Accelerated Thrombolysis Therapy

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Trial ID: NCT01513759

Purpose

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.

Official Title

A Prospective, Single-Arm, Multi-Center Trial of EkoSonic® Endovascular System and Activase for Treatment of Acute Pulmonary Embolism (PE)

Eligibility


Inclusion Criteria:

   - 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)

Exclusion Criteria:

   - 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

Intervention(s):

drug: recombinant tissue plasminogen activator

device: EKOS EkoSonic Endovascular System

Recruiting

I'm Interested

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
William Kuo, MD