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An International Pulmonary Embolism Registry Using EKOS (KNOCOUT PE)

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ClinicalTrials.gov Identifier: NCT03426124
Recruitment Status : Recruiting
First Posted : February 8, 2018
Last Update Posted : May 30, 2018
Sponsor:
Collaborator:
BTG International Inc.
Information provided by (Responsible Party):
EKOS 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.

Condition or disease Intervention/treatment
Pulmonary Embolism and Thrombosis Device: EkoSonic Endovascular System with thrombolytic

Detailed Description:

For the prospective arm of the registry a physician will have already 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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 1 Year
Official Title: Retrospective and Prospective International EkoSonic® Registry of the Treatment and Clinical OUTcomes of Patients With Pulmonary Embolism
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : March 10, 2020
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Retrospective
Individuals with submassive or massive 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
The device uses ultrasonic waves in combination with clot-dissolving thrombolytic drug to effectively dissolve clots.
Other Names:
  • Acoustic Pulse Thrombolysis
  • EKOS

Prospective
Individuals who are experiencing submassive or massive pulmonary embolism where the treating physician has selected the EKOS device and thrombolytic drug. The procedure and volume of thrombolytic drug is selected per standard of care.
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




Primary Outcome Measures :
  1. 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 ]
  2. 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

  3. 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

  4. 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 ]
  5. 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

  6. 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

  7. All-cause mortality: PE, stroke, cardiac, malignancy, other [ Time Frame: 12 months after index procedure ]
  8. Healthcare utilization during hospitalization [ Time Frame: From date of enrollment through hospital discharge, assessed up to 30 days ]
  9. 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 ]
  10. 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 ]
  11. IVC filter placement [ Time Frame: From date of enrollment through hospital discharge, assessed up to 30 days ]
    Measured by number of occurrences



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals with submassive or massive pulmonary embolism and selected to receive treatment using the EKOS device and thrombolytic.
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 subject or legally authorized representative
  • Investigator has selected the EKOS device to treat patient with massive or submassive pulmonary embolism

Prospective Exclusion Criteria:

  • Clinician deems the subject high-risk for catastrophic bleeding
  • Life expectancy < one year

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03426124


Contacts
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Contact: Timothy S Keo 425-415-3113 Timothy.Keo@btgplc.com

Locations
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United States, Virginia
Inova Alexandria Hospital Recruiting
Springfield, Virginia, United States, 22151
Contact: Lilliana Payne       lilliana.payne@inova.org   
Sponsors and Collaborators
EKOS Corporation
BTG International Inc.
Investigators
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Principal Investigator: Keith Sterling, MD Inova Alexandria Hospital

Additional Information:

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Responsible Party: EKOS Corporation
ClinicalTrials.gov Identifier: NCT03426124     History of Changes
Other Study ID Numbers: BTG-001653-01
First Posted: February 8, 2018    Key Record Dates
Last Update Posted: May 30, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by EKOS Corporation:
venous thromboembolism

Additional relevant MeSH terms:
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Thrombosis
Embolism
Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action