Phase
Condition
Pulmonary Embolism
Blood Clots
Thrombosis
Treatment
EKOS EkoSonic Endovascular System
recombinant tissue plasminogen activator
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Computed tomography (CT) evidence of proximal PE (filling defect in at least one mainor 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 resuscitatedcardiac arrest) or
- Submassive PE (RV diameter-to-LV diameter greater than or equal to [>=] 0.9 oncontrast-enhanced chest CT)
Exclusion
Exclusion Criteria:
- Stroke or transient ischemic attack (TIA), head trauma, or other active intracranialor 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 ofstudy enrollment
- Systolic blood pressure less than 80 mm Hg despite vasopressor or inotropic support
- Cardiac arrest (including pulseless electrical activity and asystole) requiring activecardiopulmonary resuscitation (CPR)
- Evidence of irreversible neurological compromise
- Life expectancy <30 days
- Use of thrombolytics or glycoprotein IIb/IIIa antagonists within 3 days prior toinclusion in the study
- Previous enrollment in the SEATTLE study
Study Design
Connect with a study center
Baptist Health
Montgomery, Alabama 36116
United StatesSite Not Available
Memorial Medical Center
Modesto, California 95355
United StatesSite Not Available
Stanford University Medical Center
Stanford, California 94305
United StatesSite Not Available
Hartford Hospital
Hartford, Connecticut
United StatesSite Not Available
Yale-New Haven Hospital
New Haven, Connecticut 06510
United StatesSite Not Available
Christiana Hospital
Newark, Delaware 19718
United StatesSite Not Available
Lakeland Regional Medical Center
Lakeland, Florida 33805
United StatesSite Not Available
Holmes Regional Medical Center
Melbourne, Florida 32901
United StatesSite Not Available
Florida Hospital
Orlando, Florida 32803
United StatesSite Not Available
Orlando Regional Medical Center
Orlando, Florida 32806
United StatesSite Not Available
Medical Center of Central Georgia
Macon, Georgia 31201
United StatesSite Not Available
Prairie Heart Institute
Springfield, Illinois 62701
United StatesSite Not Available
St. Vincent Hospital
Indianapolis, Indiana
United StatesSite Not Available
University of Kentucky, Gill Heart Institute
Lexington, Kentucky 40536
United StatesSite Not Available
East Jefferson General Hospital
New Orleans, Louisiana 70006
United StatesSite Not Available
Hackensack University Medical Center
Hackensack, New Jersey 07601
United StatesSite Not Available
Overlook Medical Center
Morristown, New Jersey 07960
United StatesSite Not Available
Holy Name Hospital
Teaneck, New Jersey 07666
United StatesSite Not Available
Montefiore
Bonx, New York
United StatesSite Not Available
Montefiore Medical Center
Bronx, New York 10467
United StatesSite Not Available
Mt. Carmel East
Columbus, Ohio 43213
United StatesSite Not Available
The Reading Hospital and Medical Center
East Reading, Pennsylvania 19611
United StatesSite Not Available
The Miriam Hospital
Providence, Rhode Island 02906
United StatesSite Not Available
Providence Memorial and Sierra Medical Center
El Paso, Texas 79902
United StatesSite Not Available
Inova Alexandria Hospital
Alexandria, Virginia 22304
United StatesSite Not Available
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