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Completed

NCT Number: NCT03426124

An International Pulmonary Embolism Registry Using EKOS

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.

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Key information

Conditions

Pulmonary Embolism and Thrombosis Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases Pulmonary Embolism Respiratory Tract Diseases Thromboembolism Thrombosis Vascular Diseases Venous Thromboembolism

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Vienna, Vienna, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EkoSonic Endovascular System with thrombolytic

Device

The device uses ultrasonic waves in combination with clot-dissolving thrombolytic drug to effectively dissolve clots.

Other names: Acoustic Pulse Thrombolysis, EKOS

Primary outcomes

  1. Change in RV/LV Ratio on Echocardiogram (Matched Pairs as Available)

    Time frame: Baseline to post-procedure (end of procedure through hospital discharge up to 14 days)

    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).

  2. Frequency and Safety Outcomes of Subjects Requiring Interventions of Adjunctive Therapies Post-procedure During Hospitalization.

    Time frame: Post-procedure hospitalization through hospital discharge up to 14 days

    Measured by number of subjects requiring interventions of adjunctive therapies received during post procedure hospitalization through hospital discharge up to 14 days.

  3. Number of Patients Who Underwent Interventional Therapies Prior to the APT Procedure and Experienced a Non- or Partial- Response.

    Time frame: From date of enrollment up to or until the placement of the Ekos device, on average 48 hours.

    Measured by number of patients who underwent interventional therapies prior to the APT procedure and experienced a non or partial response.

  4. Number of Patients Experiencing a SAEs Related to EKOS Device and/or Procedure During First 12 Months Post-APT Procedure.

    Time frame: From time of APT procedure through 12 months post-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.

  5. All-cause Mortality During First 12 Months Post-procedure.

    Time frame: Start of procedure through 12 months post-procedure.

    Number of all-cause mortality that occurred from the start of procedure through 12 months post-procedure.

  6. Healthcare Utilization

    Time frame: Measured as time from ICU admission to ICU discharge in hours (from date of enrollment through 12 months post-procedure).

    Summary of healthcare utilization from date of enrollment through discharge.

  7. 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

    Time frame: Measured as percent change in time from baseline assessment at discharge to 3 month and 12 month follow up.

    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.

  8. 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.

    Time frame: Reported results include change from baseline to 3 months and 12 months post-procedure for prospective patients.

    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.

  9. Number of Patients Needing an IVC Filter Placement

    Time frame: From date of procedure through 12 months

    Measured by number patients with an occurrence of needing an IVC filter placement.

  10. Number of Patients Experiencing Adverse Events Classified as Major Bleeding Events During First 12 Months Post-Procedure by Frequency and Severity

    Time frame: From post-procedure through 12-months post-procedure

    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).

  11. Number of Patients Experiencing VTE (Venus Thromboembolytic Events) During First 12 Months Post-Procedure by Frequency and Severity.

    Time frame: From post-procedure through 12-months post-procedure

    Number of patients experiencing events related to VTE from time of procedure through the first 12 months post-procedure by frequency and severity.

  12. Diagnosis of Pulmonary Hypertension Diagnosis

    Time frame: Analyzed 12 months post-procedure

    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.

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Collaborators

  • BTG International Inc.

Registry information

Official study title

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

Acronym: KNOCOUT PE

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 8, 2018
Registry last updated
Feb 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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