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Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Cohort
Time Perspective
Other

Arm Groups

ArmDescriptionAssigned Intervention
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
    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 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
    The device uses ultrasonic waves in combination with clot-dissolving thrombolytic drug to effectively dissolve clots.
    Other names:
    • Acoustic Pulse Thrombolysis
    • EKOS

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky
Lexington, Kentucky 40536
Contact:
Adrian Messerli, MD
awm@dr.com

More Details

NCT ID
NCT03426124
Status
Recruiting
Sponsor
EKOS Corporation

Study Contact

EKOS Corp KNOCOUT PE Study Manager
425-415-3100
KNOCOUTPE@btgplc.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.