N/A
N=1,480
An International Pulmonary Embolism Registry Using EKOS
Pulmonary Embolism and Thrombosis
Bottom Line
View on ClinicalTrials.gov: NCT03426124 ↗Enrolled (actual)
1,480
Serious AEs
9.4%
Results posted
Feb 2023
Primary outcome: Primary: Change in RV/LV Ratio on Echocardiogram (Matched Pairs as Available) — -22.6; -22.6 Percent change
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- EkoSonic Endovascular System with thrombolytic (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston Scientific Corporation
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in RV/LV Ratio on Echocardiogram (Matched Pairs as Available) |
-22.6; -22.6 | — |
| PRIMARY Frequency and Safety Outcomes of Subjects Requiring Interventions of Adjunctive Therapies Post-procedure During Hospitalization. |
7; 1; 0; 1; 5; 2 | — |
| PRIMARY Number of Patients Who Underwent Interventional Therapies Prior to the APT Procedure and Experienced a Non- or Partial- Response. |
9; 1; 5; 0; 19; 0 | — |
| PRIMARY Number of Patients Experiencing a SAEs Related to EKOS Device and/or Procedure During First 12 Months Post-APT Procedure. |
9; 5; 6; 1; 1; 0 | — |
| PRIMARY All-cause Mortality During First 12 Months Post-procedure. |
50; 15 | — |
| PRIMARY Healthcare Utilization |
44.2; 41.2 | — |
| PRIMARY 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 |
-22.52; -23.74 | — |
| PRIMARY 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. |
12.4; 11.1; 0.20; 0.19; -2.8; -2.7 | — |
| PRIMARY Number of Patients Needing an IVC Filter Placement |
50; 20 | — |
| PRIMARY Number of Patients Experiencing Adverse Events Classified as Major Bleeding Events During First 12 Months Post-Procedure by Frequency and Severity |
10; 3; 33; 8; 18; 3 | — |
| PRIMARY Number of Patients Experiencing VTE (Venus Thromboembolytic Events) During First 12 Months Post-Procedure by Frequency and Severity. |
33; 31; 15; 11; 15; 5 | — |
| PRIMARY Diagnosis of Pulmonary Hypertension Diagnosis |
0; 1 | — |
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 already received the APT treatment and those that will undergo APT treatment.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03426124). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.