Submassive and Massive Pulmonary Embolism Treatment With Ultrasound Accelerated Thrombolysis Therapy

Trial ID or NCT#

NCT01513759

Status

not recruiting iconNOT RECRUITING

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 Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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:
  1. * 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
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Contact us to find out if this trial is right for you.

Contact

William Kuo, MD

View on ClinicalTrials.gov