An International Pulmonary Embolism Registry Using EKOS

NCT03426124 | Completed Results FDA Device

• 1 other identifier: BTG-001653-01
• Study Type: observational
• Target: 1,480
• Locations: 8 countries
• Sites: 80

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.

Conditions

Pulmonary Embolism and Thrombosis

Keywords

venous thromboembolism

Outcome Measures

Primary Outcomes (12)

• 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

Study Arms (2)

Retrospective

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

Prospective

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

Interventions

EkoSonic Endovascular System with thrombolytic DEVICE

The device uses ultrasonic waves in combination with clot-dissolving thrombolytic drug to effectively dissolve clots.

Also known as: Acoustic Pulse Thrombolysis, EKOS

Prospective; Retrospective

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with intermediate-high and high risk pulmonary embolism who are selected to receive treatment using the EKOS device and thrombolytic.

You may qualify if:

• 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

You may not qualify if:

• Enrollment into the OPTALYSE PE study
• 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
• High-risk for catastrophic bleeding
• Life expectancy \< one year

Sponsors & Collaborators

• Boston Scientific Corporation: lead
• BTG International Inc.: collaborator

Study Sites (80)

Healthfinity, PLLC Advanced Cardiac & Vascular Clinic

Glendale, Arizona, 85308, United States

Location

Cedars - Sinai

Los Angeles, California, 90048, United States

Location

Radiology Imaging Associates

Englewood, Colorado, 80112, United States

Location

Bradenton Cardiology Center

Bradenton, Florida, 34205, United States

Location

Delray Medical Center

Delray Beach, Florida, 33484, United States

Location

St. Vincent's Healthcare

Jacksonville, Florida, 32204, United States

Location

University of Florida

Jacksonville, Florida, 32209, United States

Location

Memorial Hospital

Jacksonville, Florida, 32216, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Florida Hospital

Orlando, Florida, 32803, United States

Location

Orlando Health, Inc.

Orlando, Florida, 32806, United States

Location

Tallahassee Research Institute, Inc

Tallahassee, Florida, 32308, United States

Location

AdventHealth Tampa Pepin Heart Institute

Tampa, Florida, 33613, United States

Location

Emory University

Atlanta, Georgia, 30308, United States

Location

Augusta University

Augusta, Georgia, 30912, United States

Location

WellStar Medical Group

Marietta, Georgia, 30060, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

St. Mary Medical Center

Hobart, Indiana, 46342, United States

Location

St. Vincent Hospital

Indianapolis, Indiana, 46260, United States

Location

St. Elizabeth Healthcare

Crestview Hills, Kentucky, 41017, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Jewish Hospital

Louisville, Kentucky, 40202, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

St. Vincent Hospital/Reliant Medical Group

Worcester, Massachusetts, 01608, United States

Location

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

Ascension St. John Hospital

Detroit, Michigan, 88236, United States

Location

Spectrum Health

Grand Rapids, Michigan, 49503, United States

Location

Metro Health - University of Michigan Health

Wyoming, Michigan, 49519, United States

Location

Cardiology Associates of Northern Mississippi

Oxford, Mississippi, 38655, United States

Location

Saint Louis University Hospital

St Louis, Missouri, 63110, United States

Location

Dartmouth - Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Cooper University Healthcare

Camden, New Jersey, 08103, United States

Location

University of Buffalo

Buffalo, New York, 14203, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

East Carolina University

Greenville, North Carolina, 27834, United States

Location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

Summa Health

Akron, Ohio, 44304, United States

Location

Mercy Health Cincinnati

Cincinnati, Ohio, 45211, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45219, United States

Location

TriHealth Good Samaritan Bethesda North

Cincinnati, Ohio, 45220, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Mount Caramel East Hospital

Columbus, Ohio, 43213, United States

Location

University of Toledo

Toledo, Ohio, 43614, United States

Location

Genesis Healthcare System

Zanesville, Ohio, 43701, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

St. Luke's University Health Network

Bethlehem, Pennsylvania, 18015, United States

Location

St. Vincent Hospital, Allegheny Health Network

Erie, Pennsylvania, 16502, United States

Location

Temple University Hospital, Department of Thoracic Medicine & Surgery

Philadelphia, Pennsylvania, 19140, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

UPMC Hamot

Pittsburgh, Pennsylvania, 15219, United States

Location

Lankenau Medical Center

Wynnewood, Pennsylvania, 19096, United States

Location

Lexington Cardiology

West Columbia, South Carolina, 29169, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Hendrick Medical Center

Abilene, Texas, 79601, United States

Location

The Heart Hospital Baylor Plano

Plano, Texas, 75093, United States

Location

Houston Methodist Sugarland

Sugar Land, Texas, 77479, United States

Location

Inova Alexandria Hospital

Alexandria, Virginia, 22304, United States

Location

Sentara Vascular Specialists

Norfolk, Virginia, 23507, United States

Location

Providence Regional Medical Center

Everett, Washington, 98201, United States

Location

Inland Imaging

Spokane, Washington, 99204, United States

Location

CAMC

Charleston, West Virginia, 25304, United States

Location

West Virginia University Heart & Vascular Institute

Morgantown, West Virginia, 26505, United States

Location

Aurora Cardiovascular Services

Milwaukee, Wisconsin, 53205, United States

Location

Medical University of Vienna

Vienna, Austria

Location

CHRU jean Minjoz, Pôle cœur-Poumons

Besançon, France

Location

Hôpital Nord, APHM

Marseille, 13015, France

Location

Johannes Gutenberg Univeristy Mainz

Mainz, 55099, Germany

Location

Technical University Munchen

München, 80333, Germany

Location

University Medical Center Uterecht

Utrecht, Netherlands

Location

Swiss Cardiovascular Center

Bern, Switzerland

Location

University Hospital Zurich

Zurich, Switzerland

Location

Acibadem University School of Medicine

Istanbul, 34662, Turkey (Türkiye)

Location

Royal Devon and Exeter Hospital

Exeter, United Kingdom

Location

Medway NHS Foundation Trust

Gillingham, United Kingdom

Location

Oxford University Hospitals

Headington, OX3 0BL, United Kingdom

Location

Royal Free

London, NW3 2QG, United Kingdom

Location

Guy's & St Thomas' NHS Foundation Trust

London, SE1 7EH, United Kingdom

Location

St. Mary's Hospital

London, United Kingdom

Location

Related Publications (1)

• Sterling KM, Goldhaber SZ, Sharp ASP, Kucher N, Jones N, Maholic R, Meneveau N, Zlotnick D, Sayfo S, Konstantinides SV, Piazza G. Prospective Multicenter International Registry of Ultrasound-Facilitated Catheter-Directed Thrombolysis in Intermediate-High and High-Risk Pulmonary Embolism (KNOCOUT PE). Circ Cardiovasc Interv. 2024 Mar;17(3):e013448. doi: 10.1161/CIRCINTERVENTIONS.123.013448. Epub 2024 Jan 24.

  PMID: 38264938 DERIVED

MeSH Terms

Conditions

Pulmonary Embolism; Thrombosis; Venous Thromboembolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thromboembolism

Results Point of Contact

• Title: Leslie Cass
• Organization: Boston Scientific

Leslie.Cass@bsci.com

206-641-4529

Study Officials

• Keith Sterling, MD

  Inova Alexandria Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2018
• First Posted: February 8, 2018
• Study Start: March 1, 2018
• Primary Completion: June 30, 2020
• Study Completion: September 30, 2020
• Last Updated: February 22, 2023
• Results First Posted: February 22, 2023

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2); AU (1); US (65); FR (2); GB (6); TU (1); NL (1); CH (2)