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You can access this
if you have
Pulmonary Embolism and Thrombosis
and you are
between 18 and 75
The phase for this study is not defined.
Show me locations
The objective of the study is to determine the optimum dose of thrombolytic and duration of the ultrasound procedure as a treatment for acute submassive pulmonary embolism.
EkosSonic Endovascular System plus thrombolytic
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Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT02396758
Ages eligible for Study
18 Years to 75 Years
Genders eligible for Study
Accepts Healthy Volunteers
Male or female ≥ 18 years of age and ≤ 75 years of age
CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery)
PE symptom duration ≤14 days
Submassive PE: RV/LV diameter ≥ 0.9 from CTA and hemodynamically stable
Must be treated within 48 hours of diagnosis of PE by CTA
Signed Informed consent obtained from subject or Legally Authorized Representative -
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
Major surgery within seven days of screening for study enrollment
Clinician deems the subject high-risk for catastrophic bleeding
History of heparin-induced thrombocytopenia (HIT)
Catheter-based pharmacomechanical treatment for PE within 3 days of study enrollment
Systolic blood pressure (SBP) less than 90 mm Hg and/or use of vasopressors
Cardiac arrest (including pulseless electrical activity and asystole) requiring active cardiopulmonary resuscitation (CPR)
Evidence of irreversible neurological compromise
Life expectancy < one year
Use of thrombolytics or glycoprotein IIb/IIIa antagonists within 3 days prior to inclusion in the study
Out-of-Range Laboratory Values: Hematocrit < 30%, Platelets < 100 thousand/μL, INR > 3,
Creatinine outside the normal range for the treating institution
Subject is pregnant (positive pregnancy test; women of childbearing capacity must be tested) or breast feeding
Active cancer (metastatic, progressive, or treated within the last 6 months). Exception: subjects with non-melanoma primary skin cancers are eligible to participate in the study
Known allergy, hypersensitivity, or thrombocytopenia from heparin, r-tPA, or iodinated contrast except for mild-moderate contrast allergies for which steroid pre-medication can be used -
All locations for NCT02396758
United States (16)
Beverly Hills, California, United States, 90211
Tallahassee Research Institute
Tallahassee, Florida, United States, 32308
Florida Hospital Tampa
Tampa, Florida, United States, 33613
Atlanta, Georgia, United States, 30309
Augusta, Georgia, United States, 30901
St. Vincent Medical Group
Indianapolis, Indiana, United States, 46260
Louisville, Kentucky, United States, 40202
East Jefferson General Hospital
Metairie, Louisiana, United States, 70006
Detroit Medical Center
Detroit, Michigan, United States, 48201
Grand Rapids, Michigan, United States, 49506
NY-Presbyterian / Weill Cornell Med Cntr
New York, New York, United States, 10065
Mount Carmel health system
Columbus, Ohio, United States, 43213
Erie, Pennsylvania, United States, 16507
Lankenau Medical Center
Wynnewood, Pennsylvania, United States, 19096
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Houston Methodist Sugarland Hospital
Richmond, Texas, United States, 77469
View full eligibility
Tris trial is registered with FDA with number:
. The sponsor of the trial is
and it is
looking for 100 volunteers
for the current phase.
Official trial title:
Study of the Optimum Duration of Acoustic Pulse Thrombolysis Procedure in the Treatment of Acute Submassive Pulmonary Embolism
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My condition is
Pulmonary Embolism and Thrombosis
I am a healthy volunteer
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