Status:
COMPLETED
Submassive and Massive Pulmonary Embolism Treatment With Ultrasound Accelerated Thrombolysis Therapy
Lead Sponsor:
Boston Scientific Corporation
Collaborating Sponsors:
EKOS Corporation
Conditions:
Pulmonary Embolism
Acute Pulmonary Embolism
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine if the EKOS EkoSonic® Endovascular Device when used in conjunction with recombinant tissue plasminogen activator (t-PA) as a treatment for acute PE will decre...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 7 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 17 2013
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01513759
Start Date
June 7 2012
End Date
February 17 2013
Last Update
July 19 2021
Active Locations (22)
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1
Baptist Health
Montgomery, Alabama, United States, 36116
2
Memorial Medical Center
Modesto, California, United States, 95355
3
Stanford University Medical Center
Stanford, California, United States, 94305
4
Hartford Hospital
Hartford, Connecticut, United States