An International Pulmonary Embolism Registry Using EKOS

Study Overview
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Brief Summary
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This registry is designed to understand acoustic pulse thrombolysis (APT) treatment regimens used as standard of care globally for pulmonary embolism. The registry will include individuals who have already received the APT treatment and those that will undergo APT treatment.

Detailed Description
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For the prospective arm of the registry, a physician will have selected the APT procedure for the treatment of pulmonary embolism. The APT treatment and follow-up assessments are per clinical judgement and institutional standard of care which may vary at each clinical site. For the retrospective arm of the registry, the investigators will gather data from consecutive cases of individuals who received the APT treatment for pulmonary embolism. Specific baseline, treatment, and long-term health information is collected and de-identified.

Official Title
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Retrospective and Prospective International EkoSonic® Registry of the Treatment and Clinical OUTcomes of Patients With Pulmonary Embolism

Conditions
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Pulmonary Embolism and Thrombosis

Intervention / Treatment
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* Device: EkoSonic Endovascular System with thrombolytic


Participation Criteria
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Eligibility Criteria
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Retrospective Inclusion Criteria: Treated with APT procedure between January 1, 2014 and one year prior to site activation RV/LV ≥ 1.0 from diagnostic computed tomographic angiography (CTA) or echocardiogram PE symptom duration ≤ 14 days Troponin elevation Retrospective Exclusion Criteria: Enrollment into the OPTALYSE PE study Prospective Inclusion Criteria: Male or female ≥ 18 years of age and ≤ 80 years of age RV/LV ≥ 1.0 from diagnostic computed tomographic angiography (CTA) or echocardiogram PE symptom duration ≤ 14 days Troponin elevation Signed informed consent obtained from participant or legally authorized representative Investigator has selected the EKOS device to treat participant with massive or submassive pulmonary embolism Prospective Exclusion Criteria: High-risk for catastrophic bleeding Life expectancy < one year

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Retrospective<br>Individuals with intermediate-high or high risk pulmonary embolism who were consecutively treated with the Ekosonic Endovascular System (EKOS) and thrombolytic drug between January 2014 and one year prior to site activation. | Device: EkoSonic Endovascular System with thrombolytic<br>* The device uses ultrasonic waves in combination with clot-dissolving thrombolytic drug to effectively dissolve clots.<br>* Other names: EKOS;|
| Prospective<br>Individuals who are experiencing intermediate-high or high risk pulmonary embolism where the treating investigator has selected the EKOS device and thrombolytic drug. The duration of ultrasound and volume of thrombolytic drug are selected per physician discretion. | Device: EkoSonic Endovascular System with thrombolytic<br>* The device uses ultrasonic waves in combination with clot-dissolving thrombolytic drug to effectively dissolve clots.<br>* Other names: EKOS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in RV/LV Ratio on Echocardiogram (Matched Pairs as Available) | Difference (percent change) in the measurement of the right ventricular to left ventricular diameters (RV/LV) ratio as measured on baseline echocardiogram to post-procedure echocardiogram (24-48 hours post initiation of therapy). | Baseline to post-procedure (end of procedure through hospital discharge up to 14 days) | 
| Frequency and Safety Outcomes of Subjects Requiring Interventions of Adjunctive Therapies Post-procedure During Hospitalization. | Measured by number of subjects requiring interventions of adjunctive therapies received during post procedure hospitalization through hospital discharge up to 14 days. | Post-procedure hospitalization through hospital discharge up to 14 days | 
| Number of Patients Who Underwent Interventional Therapies Prior to the APT Procedure and Experienced a Non- or Partial- Response. | Measured by number of patients who underwent interventional therapies prior to the APT procedure and experienced a non or partial response. | From date of enrollment up to or until the placement of the Ekos device, on average 48 hours. | 
| Number of Patients Experiencing a SAEs Related to EKOS Device and/or Procedure During First 12 Months Post-APT Procedure. | Number of subjects experiencing a SAE related to EKOS device and/or procedure from time of procedure through the first 12 months post-APT procedure, measured by frequency and severity of events. | From time of APT procedure through 12 months post-procedure. | 
| All-cause Mortality During First 12 Months Post-procedure. | Number of all-cause mortality that occurred from the start of procedure through 12 months post-procedure. | Start of procedure through 12 months post-procedure. | 
| Healthcare Utilization | Summary of healthcare utilization from date of enrollment through discharge. | Measured as time from ICU admission to ICU discharge in hours (from date of enrollment through 12 months post-procedure). | 
| Change in Quality of Life (QOL) as Measured by the Pulmonary Embolism Quality of Life (PEmb-QOL) at the 3 Month and 12 Month Post-hospitalization Follow-up Visits | Reported as percent change in the PEmb-QOL questionnaire score from baseline timepoint to 3 months and 12 months. The PEmb-QOL measures patient's quality of life following pulmonary embolism on a scale of 1 through 5, with lower scores indicating a better outcome. | Measured as percent change in time from baseline assessment at discharge to 3 month and 12 month follow up. | 
| Change in Quality of Life (QOL) as Measured by the EQ-5D-5L VAS, Utility and Misery Scores at the 3-month and 12-month Post-hospitalization Follow-up Visits. | Reported as change in the VAS, Utility and Misery questionnaire scores from baseline timepoint and/or study visit to 3 months and 12 months. The VAS (Visual Analogue Scale) is a one question, unidimensional measure of pain intensity where a subject is asked to rate his pain on a scale of 100 through 1, with 100 indicating the best health imaginable through 1 indicating the worst health imaginable. Higher scores indicate a better outcome. The EQ-5D is a series of questions that measures Quality of Life on a scale of 0 through 5. 0 indicates no problems in daily activities and 5 indicates inability to perform daily activities. The total score is added up and compared to the total scale from 0 to 25, with 0 indicating no problems in daily activities and 25 indicating inability to perform daily activities. A lower score indicates a better outcome. | Reported results include change from baseline to 3 months and 12 months post-procedure for prospective patients. | 
| Number of Patients Needing an IVC Filter Placement | Measured by number patients with an occurrence of needing an IVC filter placement. | From date of procedure through 12 months | 
| Number of Patients Experiencing Adverse Events Classified as Major Bleeding Events During First 12 Months Post-Procedure by Frequency and Severity | Measured by number of patients experiencing adverse events related to major bleeding events from time of procedure through the first 12 months post-procedure by frequency and severity (mild, moderate, severe). | From post-procedure through 12-months post-procedure | 
| Number of Patients Experiencing VTE (Venus Thromboembolytic Events) During First 12 Months Post-Procedure by Frequency and Severity. | Number of patients experiencing events related to VTE from time of procedure through the first 12 months post-procedure by frequency and severity. | From post-procedure through 12-months post-procedure | 
| Diagnosis of Pulmonary Hypertension Diagnosis | New onset pulmonary hypertension defined as mean pulmonary artery pressure greater than 25 mm Hg by echocardiogram that persists at least 3 months after PE. | Analyzed 12 months post-procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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venous thromboembolism