An International Pulmonary Embolism Registry Using EKOS (KNOCOUT PE)
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ClinicalTrials.gov Identifier: NCT03426124 |
Recruitment Status :
Completed
First Posted : February 8, 2018
Last Update Posted : December 17, 2020
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Condition or disease | Intervention/treatment |
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Pulmonary Embolism and Thrombosis | Device: EkoSonic Endovascular System with thrombolytic |
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] |
Actual 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 |
Actual Primary Completion Date : | June 30, 2020 |
Actual Study Completion Date : | September 30, 2020 |

Group/Cohort | Intervention/treatment |
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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.
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Device: EkoSonic Endovascular System with thrombolytic
The device uses ultrasonic waves in combination with clot-dissolving thrombolytic drug to effectively dissolve clots.
Other Names:
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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.
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Device: EkoSonic Endovascular System with thrombolytic
The device uses ultrasonic waves in combination with clot-dissolving thrombolytic drug to effectively dissolve clots.
Other Names:
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- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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 |
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

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

Principal Investigator: | Keith Sterling, MD | Inova Alexandria Hospital |
Responsible Party: | EKOS Corporation |
ClinicalTrials.gov Identifier: | NCT03426124 |
Other Study ID Numbers: |
BTG-001653-01 |
First Posted: | February 8, 2018 Key Record Dates |
Last Update Posted: | December 17, 2020 |
Last Verified: | December 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
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 |
venous thromboembolism |
Pulmonary Embolism Thrombosis Embolism Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases |
Lung Diseases Respiratory Tract Diseases Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action |