A Prospective, Single-arm, Multi-center Trial of EkoSonic® Endovascular System and Activase for Treatment of Acute Pulmonary Embolism (PE).
Trial ID or NCT#
NCT01513759
Status
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
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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
Contact us to find out if this trial is right for you.
Contact
William Kuo, MD
View on ClinicalTrials.gov
