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Trial record 1 of 1 for:    Retrospective and Prospective International EkoSonic Registry of the Treatment and Clinical Outcomes of Patients With Pulmonary Embolism
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An International Pulmonary Embolism Registry Using EKOS (KNOCOUT PE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03426124
Recruitment Status : Completed
First Posted : February 8, 2018
Last Update Posted : December 17, 2020
Sponsor:
Collaborator:
BTG International Inc.
Information provided by (Responsible Party):
EKOS Corporation

Tracking Information
First Submitted Date January 29, 2018
First Posted Date February 8, 2018
Last Update Posted Date December 17, 2020
Actual Study Start Date March 1, 2018
Actual Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 15, 2020)
  • Change in the ratio of the measurement of the right ventricular to left ventricular diameters (RV/LV) as measured by echocardiogram or CTA (matched pairs as available) [ Time Frame: Baseline to 24 to 48 hours after the start of the APT procedure ]
    Change in RV/LV ratio at 24 to 48 hours.
  • Persistence of pulmonary hypertension defined as mean pulmonary artery pressure greater than 25mm Hg by echocardiogram [ Time Frame: 3 months post PE diagnosis ]
    Measured by frequency and severity
  • Other urgent interventions for index PE following APT procedure [ Time Frame: From date of enrollment through hospital discharge, assessed up to 30 days ]
    Measured by number of interventions
  • Number of participants with non or partial response to other interventional procedures with APT procedure as adjunctive treatment during hospitalization for index PE [ Time Frame: From date of enrollment up to or until the placement of the Ekos device, which is enrollment. ]
    Measured by number of participants
  • Serious adverse experiences (SAE) related to the device and procedure, major bleeding, and venous thromboembolic disease (VTE) events during index hospitalization [ Time Frame: From date of enrollment through hospital discharge, assessed up to 30 days ]
    Measured by frequency and severity
  • Recurrent symptomatic VTE and bleeding events [ Time Frame: After the index hospital discharge and during first 12 months ]
    Measured by frequency and duration of hospital stay
  • All-cause mortality: PE, stroke, cardiac, malignancy, other [ Time Frame: Up to 12 months after index procedure. ]
    Summary of all-cause mortality
  • Healthcare utilization during hospitalization [ Time Frame: From date of enrollment through 12 month post index procedure. ]
    Summary of healthcare utilization from date of enrollment through 12 month post index procedure
  • Change in quality of life (QOL) as measured by the Pulmonary Embolism Quality of Life (PEmb-QOL) at post-treatment before discharge and all post-hospitalization follow-up visits [ Time Frame: At baseline and at 3 and 12 months post index procedure. ]
    Summary by timepoint and/or study visits including change from baseline through continuous post procedure endpoints.
  • Change in quality of life (QOL) as measured by the EuroQol five dimension five level questionnaire (EQ-5D-5L) at post-treatment before discharge and all post-hospitalization follow-up visits [ Time Frame: At baseline and at 3 and 12 months post index procedure. ]
    Summary by timepoint and/or study visits including change from baseline through continuous post procedure endpoints.
  • IVC filter placement [ Time Frame: From date of enrollment through 12 months ]
    Measured by number of occurrences
Original Primary Outcome Measures
 (submitted: February 1, 2018)
  • Change in the ratio of the measurement of the right ventricular to left ventricular diameters (RV/LV) as measured by echocardiogram [ Time Frame: Baseline to 24 hours after the start of the APT procedure ]
  • Persistence of pulmonary hypertension defined as mean pulmonary artery pressure greater than 25mm Hg by echocardiogram [ Time Frame: 6 months after PE diagnosis ]
    Measured by number of frequency and severity
  • Other urgent interventions for index PE [ Time Frame: From date of enrollment through hospital discharge, assessed up to 30 days ]
    Measured by number of interventions
  • Number of patients with non or partial response to other interventional procedures with APT procedure as adjunctive for index PE [ Time Frame: From date of enrollment through hospital discharge, assessed up to 30 days ]
  • Serious adverse experiences (SAE) related to the device and procedure, major bleeding, and venous thromboembolic disease (VTE) events during index hospitalization [ Time Frame: From date of enrollment through hospital discharge, assessed up to 30 days ]
    Measured by frequency and severity
  • Recurrent symptomatic VTE and bleeding events [ Time Frame: After the index hospital discharge and during first 12 months ]
    Measured by frequency and duration of stay
  • All-cause mortality: PE, stroke, cardiac, malignancy, other [ Time Frame: 12 months after index procedure ]
  • Healthcare utilization during hospitalization [ Time Frame: From date of enrollment through hospital discharge, assessed up to 30 days ]
  • Quality of life (QOL) as measured by the Pulmonary Embolism Quality of Life (PEmb-QOL) at all post-hospitalization follow-up visits [ Time Frame: 12 months after index procedure ]
  • Quality of life (QOL) as measured by the EuroQol five dimension five level questionnaire (EQ-5D-5L) at all post-hospitalization follow-up visits [ Time Frame: 12 months after index procedure ]
  • IVC filter placement [ Time Frame: From date of enrollment through hospital discharge, assessed up to 30 days ]
    Measured by number of occurrences
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration 1 Year
Biospecimen Not Provided
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.
Condition Pulmonary Embolism and Thrombosis
Intervention Device: EkoSonic Endovascular System with thrombolytic
The device uses ultrasonic waves in combination with clot-dissolving thrombolytic drug to effectively dissolve clots.
Other Names:
  • Acoustic Pulse Thrombolysis
  • EKOS
Study Groups/Cohorts
  • 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.
    Intervention: 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.
    Intervention: Device: EkoSonic Endovascular System with thrombolytic
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 1, 2018)
1500
Original Estimated Enrollment Same as current
Actual Study Completion Date September 30, 2020
Actual Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Austria,   France,   Germany,   Netherlands,   Switzerland,   Turkey,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03426124
Other Study ID Numbers BTG-001653-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party EKOS Corporation
Study Sponsor EKOS Corporation
Collaborators BTG International Inc.
Investigators
Principal Investigator: Keith Sterling, MD Inova Alexandria Hospital
PRS Account EKOS Corporation
Verification Date December 2020