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Submassive and Massive Pulmonary Embolism Treatment With Ultrasound Accelerated Thrombolysis Therapy
Recruiting
I'm InterestedTrial 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 InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
William Kuo, MD