An International Pulmonary Embolism Registry Using EKOS

Completed

Conditions: Pulmonary Embolism and Thrombosis

Registration Number: NCT03426124

Lead Sponsor: Boston Scientific Corporation

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1480

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in RV/LV Ratio on Echocardiogram (Matched Pairs as Available)	Baseline to post-procedure (end of procedure through hospital discharge up to 14 days)	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).
Frequency and Safety Outcomes of Subjects Requiring Interventions of Adjunctive Therapies Post-procedure During Hospitalization.	Post-procedure hospitalization through hospital discharge up to 14 days	Measured by number of subjects requiring interventions of adjunctive therapies received during 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.	From date of enrollment up to or until the placement of the Ekos device, on average 48 hours.	Measured by number of patients who underwent interventional therapies prior to the APT procedure and experienced a non or partial response.
Number of Patients Experiencing a SAEs Related to EKOS Device and/or Procedure During First 12 Months Post-APT Procedure.	From time of APT procedure through 12 months post-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.
All-cause Mortality During First 12 Months Post-procedure.	Start of procedure through 12 months post-procedure.	Number of all-cause mortality that occurred from the start of procedure through 12 months post-procedure.
Healthcare Utilization	Measured as time from ICU admission to ICU discharge in hours (from date of enrollment through 12 months post-procedure).	Summary of healthcare utilization from date of enrollment through discharge.
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	Measured as percent change in time from baseline assessment at discharge to 3 month and 12 month follow up.	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.
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 results include change from baseline to 3 months and 12 months post-procedure for prospective patients.	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.
Number of Patients Needing an IVC Filter Placement	From date of procedure through 12 months	Measured by number patients with an occurrence of needing an IVC filter placement.
Number of Patients Experiencing Adverse Events Classified as Major Bleeding Events During First 12 Months Post-Procedure by Frequency and Severity	From post-procedure through 12-months post-procedure	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).
Number of Patients Experiencing VTE (Venus Thromboembolytic Events) During First 12 Months Post-Procedure by Frequency and Severity.	From post-procedure through 12-months post-procedure	Number of patients experiencing events related to VTE from time of procedure through the first 12 months post-procedure by frequency and severity.
Diagnosis of Pulmonary Hypertension Diagnosis	Analyzed 12 months post-procedure	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.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (80): Healthfinity, PLLC Advanced Cardiac & Vascular Clinic
🇺🇸
Glendale, Arizona, United States
Cedars - Sinai
🇺🇸
Los Angeles, California, United States
Radiology Imaging Associates
🇺🇸
Englewood, Colorado, United States
Bradenton Cardiology Center
🇺🇸
Bradenton, Florida, United States
Delray Medical Center
🇺🇸
Delray Beach, Florida, United States
St. Vincent's Healthcare
🇺🇸
Jacksonville, Florida, United States
University of Florida
🇺🇸
Jacksonville, Florida, United States
Memorial Hospital
🇺🇸
Jacksonville, Florida, United States
University of Miami
🇺🇸
Miami, Florida, United States
Florida Hospital
🇺🇸
Orlando, Florida, United States
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Healthfinity, PLLC Advanced Cardiac & Vascular Clinic
🇺🇸Glendale, Arizona, United States