Status:
COMPLETED
An International Pulmonary Embolism Registry Using EKOS
Lead Sponsor:
Boston Scientific Corporation
Collaborating Sponsors:
BTG International Inc.
Conditions:
Pulmonary Embolism and Thrombosis
Eligibility:
All Genders
18-80 years
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 al...
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 judgemen...
Eligibility Criteria
Inclusion
- Retrospective
- 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
- 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
Key Trial Info
Start Date :
March 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 30 2020
Estimated Enrollment :
1480 Patients enrolled
Trial Details
Trial ID
NCT03426124
Start Date
March 1 2018
End Date
September 30 2020
Last Update
February 22 2023
Active Locations (80)
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1
Healthfinity, PLLC Advanced Cardiac & Vascular Clinic
Glendale, Arizona, United States, 85308
2
Cedars - Sinai
Los Angeles, California, United States, 90048
3
Radiology Imaging Associates
Englewood, Colorado, United States, 80112
4
Bradenton Cardiology Center
Bradenton, Florida, United States, 34205