Clinical trial NCT03426124: An International Pulmonary Embolism Registry Using EKOS
Official title: Retrospective and Prospective International EkoSonic® Registry of the Treatment and Clinical OUTcomes of Patients With Pulmonary Embolism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Embolism and Thrombosis
Keywords: venous thromboembolism
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
Collaborators: name: BTG International Inc.
First posted: 2018-02-08
Enrollment: 1480
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in RV/LV Ratio on Echocardiogram (Matched Pairs as Available)
timeFrame: Baseline to post-procedure (end of procedure through hospital discharge up to 14 days)
measure: Frequency and Safety Outcomes of Subjects Requiring Interventions of Adjunctive Therapies Post-procedure During Hospitalization.
timeFrame: Post-procedure hospitalization through hospital discharge up to 14 days
measure: Number of Patients Who Underwent Interventional Therapies Prior to the APT Procedure and Experienced a Non- or Partial- Response.
timeFrame: From date of enrollment up to or until the placement of the Ekos device, on average 48 hours.
measure: Number of Patients Experiencing a SAEs Related to EKOS Device and/or Procedure During First 12 Months Post-APT Procedure.
timeFrame: From time of APT procedure through 12 months post-procedure.
measure: All-cause Mortality During First 12 Months Post-procedure.
timeFrame: Start of procedure through 12 months post-procedure.
measure: Healthcare Utilization
timeFrame: Measured as time from ICU admission to ICU discharge in hours (from date of enrollment through 12 months post-procedure).
measure: 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
timeFrame: Measured as percent change in time from baseline assessment at discharge to 3 month and 12 month follow up.
measure: 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.
timeFrame: Reported results include change from baseline to 3 months and 12 months post-procedure for prospective patients.
measure: Number of Patients Needing an IVC Filter Placement
timeFrame: From date of procedure through 12 months
measure: Number of Patients Experiencing Adverse Events Classified as Major Bleeding Events During First 12 Months Post-Procedure by Frequency and Severity
timeFrame: From post-procedure through 12-months post-procedure
measure: Number of Patients Experiencing VTE (Venus Thromboembolytic Events) During First 12 Months Post-Procedure by Frequency and Severity.
timeFrame: From post-procedure through 12-months post-procedure
measure: Diagnosis of Pulmonary Hypertension Diagnosis
timeFrame: Analyzed 12 months post-procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Healthfinity, PLLC Advanced Cardiac & Vascular Clinic
state: Arizona
city: Los Angeles
country: United States
facility: Cedars - Sinai
state: California
city: Englewood
country: United States
facility: Radiology Imaging Associates
state: Colorado
city: Bradenton
country: United States
facility: Bradenton Cardiology Center
state: Florida
city: Delray Beach
country: United States
facility: Delray Medical Center
state: Florida
city: Jacksonville
country: United States
facility: St. Vincent's Healthcare
state: Florida
city: Jacksonville
country: United States
facility: University of Florida
state: Florida
city: Jacksonville
country: United States
facility: Memorial Hospital
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Orlando
country: United States
facility: Orlando Health, Inc.
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Research Institute, Inc
state: Florida
city: Tampa
country: United States
facility: AdventHealth Tampa Pepin Heart Institute
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Marietta
country: United States
facility: WellStar Medical Group
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Hobart
country: United States
facility: St. Mary Medical Center
state: Indiana
city: Indianapolis
country: United States
facility: St. Vincent Hospital
state: Indiana
city: Crestview Hills
country: United States
facility: St. Elizabeth Healthcare
state: Kentucky
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Louisville
country: United States
facility: Jewish Hospital
state: Kentucky
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Worcester
country: United States
facility: St. Vincent Hospital/Reliant Medical Group
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Detroit
country: United States
facility: Ascension St. John Hospital
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health
state: Michigan
city: Wyoming
country: United States
facility: Metro Health - University of Michigan Health
state: Michigan
city: Oxford
country: United States
facility: Cardiology Associates of Northern Mississippi
state: Mississippi
city: Saint Louis
country: United States
facility: Saint Louis University Hospital
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth - Hitchcock Medical Center
state: New Hampshire
city: Camden
country: United States
facility: Cooper University Healthcare
state: New Jersey
city: Buffalo
country: United States
facility: University of Buffalo
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
city: Akron
country: United States
facility: Summa Health
state: Ohio
city: Cincinnati
country: United States
facility: Mercy Health Cincinnati
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cincinnati
country: United States
facility: TriHealth Good Samaritan Bethesda North
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Columbus
country: United States
facility: Mount Caramel East Hospital
state: Ohio
city: Toledo
country: United States
facility: University of Toledo
state: Ohio
city: Zanesville
country: United States
facility: Genesis Healthcare System
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Bethlehem
country: United States
facility: St. Luke's University Health Network
state: Pennsylvania
city: Erie
country: United States
facility: St. Vincent Hospital, Allegheny Health Network
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital, Department of Thoracic Medicine & Surgery
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Hamot
state: Pennsylvania
city: Wynnewood
country: United States
facility: Lankenau Medical Center
state: Pennsylvania
city: West Columbia
country: United States
facility: Lexington Cardiology
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Abilene
country: United States
facility: Hendrick Medical Center
state: Texas
city: Plano
country: United States
facility: The Heart Hospital Baylor Plano
state: Texas
city: Sugar Land
country: United States
facility: Houston Methodist Sugarland
state: Texas
city: Alexandria
country: United States
facility: Inova Alexandria Hospital
state: Virginia
city: Norfolk
country: United States
facility: Sentara Vascular Specialists
state: Virginia
city: Everett
country: United States
facility: Providence Regional Medical Center
state: Washington
city: Spokane
country: United States
facility: Inland Imaging
state: Washington
city: Charleston
country: United States
facility: CAMC
state: West Virginia
city: Morgantown
country: United States
facility: West Virginia University Heart & Vascular Institute
state: West Virginia
city: Milwaukee
country: United States
facility: Aurora Cardiovascular Services
state: Wisconsin
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Besançon
country: France
facility: CHRU jean Minjoz, Pôle cœur-Poumons
city: Marseille
country: France
facility: Hôpital Nord, APHM
city: Mainz
country: Germany
facility: Johannes Gutenberg Univeristy Mainz
city: Munchen
country: Germany
facility: Technical University Munchen
city: Utrecht
country: Netherlands
facility: University Medical Center Uterecht
city: Bern
country: Switzerland
facility: Swiss Cardiovascular Center
city: Zurich
country: Switzerland
facility: University Hospital Zurich
city: Istanbul
country: Turkey
facility: Acibadem University School of Medicine
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter Hospital
city: Gillingham
country: United Kingdom
facility: Medway NHS Foundation Trust
city: Headington
country: United Kingdom
facility: Oxford University Hospitals
city: London
country: United Kingdom
facility: Royal Free
city: London
country: United Kingdom
facility: Guy's & St Thomas' NHS Foundation Trust
city: London
country: United Kingdom
facility: St. Mary's Hospital
Study officials:
affiliation: Inova Alexandria Hospital
name: Keith Sterling, MD
role: PRINCIPAL_INVESTIGATOR
References: