Submassive and Massive Pulmonary Embolism Treatment With Ultrasound Accelerated Thrombolysis Therapy (NCT01513759) | Clinical Trial Compass
CompletedPhase 3
Submassive and Massive Pulmonary Embolism Treatment With Ultrasound Accelerated Thrombolysis Therapy
United States150 participantsStarted 2012-06-07
Plain-language 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 decrease the ratio of right ventricle (RV) to left ventricle (LV) diameter within 48 =/- 6 hours in participants with massive or submassive PE.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
Change From Baseline in the Right Ventricle (RV) Diameter-to-Left Ventricle (LV) Diameter Ratio Within 48 +/- 6 Hours of Initiation of Therapy
Timeframe: Baseline, within 48 +/- 6 hours of initiation of therapy
2
Number of Participants With Major Bleeding
Timeframe: From start of study drug infusion up to 72 hours