Submassive Pulmonary Embolism Experience With EKOS

Study Overview
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Brief Summary
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This single site study evaluates the efficacy of ultrasound accelerated thrombolysis using EKOS Endovascular Device with a standard infusion of thrombolytics for treatment of PE

Detailed Description
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Previous clinical trials examining thrombolytics used to treat Acute Submassive PE, many times will use fixed dose and duration. Little research has been conducted on the physiologic implication of resolution of symptoms. It seems reasonable, that symptomatic relief results from some degree of hemodynamic normalization. This study will seek to examine the extent to which the hemodynamic impairment is normalized from a thrombolytic treatment protocol with an endpoint of therapy determined as resolution of presenting symptoms. Treatment plans will utilize the MBS (Modified Borg Scale) score to help evaluate and measure outcome-based care, quantifying shortness of breath.

Official Title
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Submassive Pulmonary Embolism Experience With EKOS

Conditions
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Thrombolytic Therapy, Thrombolysis, Mechanical Thrombolysis, Pulmonary Embolism

Intervention / Treatment
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* Device: EkoSonic Endovascular System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute symptomatic PE confirmed by CT, with filling defect in at least one main or segmental pulmonary artery. RV dysfunction as evidenced by RV/LV ratio > 0.9 on echo Ability to give informed consent or Legally Authorized Representative (LAR) is able to give consent PE symptom duration < 21 days Age >18 years And, a MBS baseline measurement above 3 plus at least one of the following: O2 sat < 90% RA, or inability to maintain a HR <100, or inability to maintain a Systolic Bp > 100. Whichever measurement is chosen for inclusion criteria in addition to the MBS will also be used in determination of therapeutic endpoint (i.e. O2 Sat., HR<100 or BP >100).. 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 Hemoglobin (Hgb) < 8.0 Platelets < 60 thousand/µL Major surgery within seven days 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: EkoSonic Endovascular System|Ultrasound catheter-directed thrombolysis.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of RV dysfunction | Reduction of RV dysfunction as evidenced by a reduction in RVSP and or a reduction in RV/LV ratio measured by echo at baseline and again at 48 ±6 hours post EKOS catheter removal | 48 hours post catheter removal | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thrombolysis, Ultrasound Thrombolysis, Pulmonary Embolism, Saddle PE, Submassive PE, Massive PE, Bilateral PE