Information about the 2019 Novel Coronavirus
New to MyHealth?
Manage Your Care From Anywhere.
Access your health information from any device with MyHealth. You can message your clinic, view lab results, schedule an appointment, and pay your bill.
ALREADY HAVE AN ACCESS CODE?
DON'T HAVE AN ACCESS CODE?
NEED MORE DETAILS?
MyHealth for Mobile
Get the iPhone MyHealth app »
Get the Android MyHealth app »
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