An International Pulmonary Embolism Registry Using EKOS

Pulmonary Embolism and Thrombosis Clinical Trial

— KNOCOUT PE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03426124
• Other study ID #: BTG-001653-01
• Status: Completed
• Start date: March 1, 2018
• Est. completion date: September 30, 2020

Study information

• Verified date: May 2022
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 1480
• Est. completion date: September 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Embolism
• Embolism and Thrombosis
• Pulmonary Embolism
• Pulmonary Embolism and Thrombosis
• Thrombosis

Intervention

Device:
• EkoSonic Endovascular System with thrombolytic
The device uses ultrasonic waves in combination with clot-dissolving thrombolytic drug to effectively dissolve clots.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Boston Scientific Corporation	BTG International Inc.

Countries where clinical trial is conducted

United States,  Austria,  France,  Germany,  Netherlands,  Switzerland,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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.
Primary	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.
Primary	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.
Primary	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).
Primary	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.
Primary	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.
Primary	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
Primary	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
Primary	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
Primary	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