An International Pulmonary Embolism Registry Using EKOS

Completed

Conditions: Pulmonary Embolism and Thrombosis

Interventions: Device: EkoSonic Endovascular System with thrombolytic

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

Arm && Interventions

Group	Intervention	Description
Prospective	EkoSonic Endovascular System with thrombolytic	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.
Retrospective	EkoSonic Endovascular System with thrombolytic	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.

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
St. Vincent's Healthcare
🇺🇸
Jacksonville, Florida, United States
University of Florida
🇺🇸
Jacksonville, Florida, United States
Cardiology Associates of Northern Mississippi
🇺🇸
Oxford, Mississippi, United States
Memorial Hospital
🇺🇸
Jacksonville, Florida, United States
University Hospital Zurich
🇨🇭
Zurich, Switzerland
Cooper University Healthcare
🇺🇸
Camden, New Jersey, United States
Metro Health - University of Michigan Health
🇺🇸
Wyoming, Michigan, United States
Swiss Cardiovascular Center
🇨🇭
Bern, Switzerland
Acibadem University School of Medicine
🇹🇷
Istanbul, Turkey
Delray Medical Center
🇺🇸
Delray Beach, Florida, United States
Radiology Imaging Associates
🇺🇸
Englewood, Colorado, United States
Bradenton Cardiology Center
🇺🇸
Bradenton, Florida, United States
Augusta University
🇺🇸
Augusta, Georgia, United States
Loyola University Medical Center
🇺🇸
Maywood, Illinois, United States
Houston Methodist Sugarland
🇺🇸
Sugar Land, Texas, United States
West Virginia University Heart & Vascular Institute
🇺🇸
Morgantown, West Virginia, United States
Duke University Medical Center
🇺🇸
Durham, North Carolina, United States
Mercy Health Cincinnati
🇺🇸
Cincinnati, Ohio, United States
University of Cincinnati
🇺🇸
Cincinnati, Ohio, United States
Ascension St. John Hospital
🇺🇸
Detroit, Michigan, United States
Oregon Health & Science University
🇺🇸
Portland, Oregon, United States
Cedars - Sinai
🇺🇸
Los Angeles, California, United States
Tallahassee Research Institute, Inc
🇺🇸
Tallahassee, Florida, United States
Northwestern University
🇺🇸
Chicago, Illinois, United States
St. Elizabeth Healthcare
🇺🇸
Crestview Hills, Kentucky, United States
University of Miami
🇺🇸
Miami, Florida, United States
WellStar Medical Group
🇺🇸
Marietta, Georgia, United States
TriHealth Good Samaritan Bethesda North
🇺🇸
Cincinnati, Ohio, United States
Brigham & Women's Hospital
🇺🇸
Boston, Massachusetts, United States
St. Mary Medical Center
🇺🇸
Hobart, Indiana, United States
St. Vincent Hospital
🇺🇸
Indianapolis, Indiana, United States
Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
Summa Health
🇺🇸
Akron, Ohio, United States
St. Vincent Hospital, Allegheny Health Network
🇺🇸
Erie, Pennsylvania, United States
Dartmouth - Hitchcock Medical Center
🇺🇸
Lebanon, New Hampshire, United States
St. Vincent Hospital/Reliant Medical Group
🇺🇸
Worcester, Massachusetts, United States
Mount Caramel East Hospital
🇺🇸
Columbus, Ohio, United States
University of Toledo
🇺🇸
Toledo, Ohio, United States
Spectrum Health
🇺🇸
Grand Rapids, Michigan, United States
East Carolina University
🇺🇸
Greenville, North Carolina, United States
Vanderbilt University Medical Center
🇺🇸
Nashville, Tennessee, United States
Hendrick Medical Center
🇺🇸
Abilene, Texas, United States
Medical University of Vienna
🇦🇹
Vienna, Austria
Sentara Vascular Specialists
🇺🇸
Norfolk, Virginia, United States
Providence Regional Medical Center
🇺🇸
Everett, Washington, United States
Temple University Hospital, Department of Thoracic Medicine & Surgery
🇺🇸
Philadelphia, Pennsylvania, United States
The Heart Hospital Baylor Plano
🇺🇸
Plano, Texas, United States
CHRU jean Minjoz, Pôle cœur-Poumons
🇫🇷
Besançon, France
Technical University Munchen
🇩🇪
Munchen, Germany
Lankenau Medical Center
🇺🇸
Wynnewood, Pennsylvania, United States
Inova Alexandria Hospital
🇺🇸
Alexandria, Virginia, United States
Inland Imaging
🇺🇸
Spokane, Washington, United States
CAMC
🇺🇸
Charleston, West Virginia, United States
University Medical Center Uterecht
🇳🇱
Utrecht, Netherlands
Royal Free
🇬🇧
London, United Kingdom
Guy's & St Thomas' NHS Foundation Trust
🇬🇧
London, United Kingdom
AdventHealth Tampa Pepin Heart Institute
🇺🇸
Tampa, Florida, United States
University of Michigan Health System
🇺🇸
Ann Arbor, Michigan, United States
Aurora Cardiovascular Services
🇺🇸
Milwaukee, Wisconsin, United States
Emory University
🇺🇸
Atlanta, Georgia, United States
Saint Louis University Hospital
🇺🇸
Saint Louis, Missouri, United States
University of Buffalo
🇺🇸
Buffalo, New York, United States
Wake Forest Baptist Health
🇺🇸
Winston-Salem, North Carolina, United States
Ohio State University
🇺🇸
Columbus, Ohio, United States
Genesis Healthcare System
🇺🇸
Zanesville, Ohio, United States
St. Luke's University Health Network
🇺🇸
Bethlehem, Pennsylvania, United States
Allegheny General Hospital
🇺🇸
Pittsburgh, Pennsylvania, United States
UPMC Hamot
🇺🇸
Pittsburgh, Pennsylvania, United States
Hôpital Nord, APHM
🇫🇷
Marseille, France
Johannes Gutenberg Univeristy Mainz
🇩🇪
Mainz, Germany
St. Mary's Hospital
🇬🇧
London, United Kingdom
Royal Devon and Exeter Hospital
🇬🇧
Exeter, United Kingdom
Medway NHS Foundation Trust
🇬🇧
Gillingham, United Kingdom
Oxford University Hospitals
🇬🇧
Headington, United Kingdom
Jewish Hospital
🇺🇸
Louisville, Kentucky, United States
Florida Hospital
🇺🇸
Orlando, Florida, United States
Orlando Health, Inc.
🇺🇸
Orlando, Florida, United States
University of Kentucky
🇺🇸
Lexington, Kentucky, United States
Lexington Cardiology
🇺🇸
West Columbia, South Carolina, United States