Long Term Effects of Treating Submassive Pulmonary Embolism With Ultra-sound Accelerated Thrombolysis

Study Overview
=================
Brief Summary
-----------------
Patients with Submassive Pulmonary Embolism treated with ultra-sound therapy will have an improved right ventricular function 72 hours post treatment.

Official Title
-----------------
Submassive Pulmonary Embolism Treatment With Ultrasound-Accelerated Thrombolysis

Conditions
-----------------
Submassive Pulmonary Embolism

Intervention / Treatment
-----------------
* Other: submassive PA treatment with Ekosonic endo device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with acute (< or = 14 days)symptomatic pulmonary embolism by CT Angiogram of the thorax with embolus involving at least one main or lower lobe pulmonary artery and RV:LV ratio > 0.9 Exclusion Criteria: age > 80 Recent thrombolytic therapy (with in 4 days) Active bleeding or know bleeding diathesis Known coagulopathy (including treatment with vitamin K antagonists) INR > 3 and/or PTT > 50 Thrombocytopenia (PLT cound < 100,000) History of any intracranial or intraspinal surgery, trauma or bleed Intracranial neoplasms, AVM, or aneurysm Recent (< 1 month) GI bleed Recent (< 3 months) internal eye surgery or hemorrhagic retinopathy Recent (< 7 days) major surgery, trauma, or obstetrical delivery Renal insufficiency with eGFR < 45 ml/min Known allergy, hypersensitivity, or thrombocytopenia from heparin or tPA Hemodynamic instability defined as need for cardiopulmonay resuscitation, Systolic BP > 90 mm Hg for > 15 min or need for pressor agents to maintain BP > 90. Severe Hypertension (sustained systolic > 180 mm Hg or diastolic > 90 mm Hg. Pregnant patients known right to left shunt Large (>10 mm)intracardiac thrombus Use of thrombolytics or glycoprotein IIb/IIIa antangonists within 3 days of inclusion. Life expectancy < 30 days

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| pulmonary embolism<br>patients with submassive pulmonary embolism | Other: submassive PA treatment with Ekosonic endo device<br>* Ultra Sound energy along with tPA to treat submassive pulmonary embolism<br>* Other names: Ekosonic Endovascular Device;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Right Ventricular:Left Ventricular ratio | Treatment will show improved Right Ventricular:Left Ventricular ratio at 72 hours post. | baseline to 72 hours post | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrent pulmonary embolism | Will assess whether a recurrent Pulmonary Embolism has happened at 30 day post procedure or earlier | 30 days post procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
submassive pulmonary embolism, Ultrasonic energy, Ekosonic Endovascular Device, RV:LV function after Pulmonary Embolism