An International Pulmonary Embolism Registry Using EKOS (KNOCOUT PE)

Boston Scientific

Status: Completed

Conditions: Pulmonary Embolism and Thrombosis

Treatments: Device: EkoSonic Endovascular System with thrombolytic

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03426124

BTG-001653-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,480 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

1,480 participants in 2 patient groups

Retrospective

Description:

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.

Treatment:

Device: EkoSonic Endovascular System with thrombolytic

Prospective

Description:

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.

Treatment:

Device: EkoSonic Endovascular System with thrombolytic