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A Prospective, Single-arm, Multi-center Trial of EkoSonic® Endovascular System and Activase for Treatment of Acute Pulmonary Embolism (PE).
Trial ID or NCT#
Status
NOT RECRUITING
Purpose
The purpose of this study is to determine if the EKOS EkoSonic® Endovascular Device when used in conjunction with recombinant t-PA as a treatment for acute pulmonary embolism (PE) will decrease the ratio of RV to LV diameter within 48 ± 6 hours in patients 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
- - 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)
- - 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
Contact us to find out if this trial is right for you.
CONTACT
William Kuo, MD
View on ClinicalTrials.gov