An observational study in Pulmonary Embolism and Thrombosis, sponsored by Boston Scientific Corporation. Completed at 80 sites in 8 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-02-22.
Sponsored by Boston Scientific Corporation · Observational
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.
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.
Individuals with intermediate-high and high risk pulmonary embolism who are selected to receive treatment using the EKOS device and thrombolytic.
Retrospective Inclusion Criteria:
Retrospective Exclusion Criteria:
Prospective Inclusion Criteria:
Prospective Exclusion Criteria:
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.
Device: EkoSonic Endovascular System with thrombolytic
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.
Device: EkoSonic Endovascular System with thrombolytic
The device uses ultrasonic waves in combination with clot-dissolving thrombolytic drug to effectively dissolve clots.
Also known as: Acoustic Pulse Thrombolysis, EKOS
Change in RV/LV Ratio on Echocardiogram (Matched Pairs as Available)
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).
Time frame: Baseline to post-procedure (end of procedure through hospital discharge up to 14 days)
Frequency and Safety Outcomes of Subjects Requiring Interventions of Adjunctive Therapies Post-procedure During Hospitalization.
Measured by number of subjects requiring interventions of adjunctive therapies received during post procedure hospitalization through hospital discharge up to 14 days.
Time frame: Post-procedure hospitalization through hospital discharge up to 14 days
Number of Patients Who Underwent Interventional Therapies Prior to the APT Procedure and Experienced a Non- or Partial- Response.
Measured by 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.
Number of Patients Experiencing a SAEs Related to EKOS Device and/or Procedure During First 12 Months Post-APT 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.
Time frame: From time of APT procedure through 12 months post-procedure.
All-cause Mortality During First 12 Months Post-procedure.
Number of all-cause mortality that occurred from the start of procedure through 12 months post-procedure.
Time frame: Start of procedure through 12 months post-procedure.
Healthcare Utilization
Summary of healthcare utilization from date of enrollment through discharge.
Time frame: Measured as time from ICU admission to ICU discharge in hours (from date of enrollment through 12 months post-procedure).
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
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.
Time frame: Measured as percent change in time from baseline assessment at discharge to 3 month and 12 month follow up.
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.
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.
Time frame: Reported results include change from baseline to 3 months and 12 months post-procedure for prospective patients.
Number of Patients Needing an IVC Filter Placement
Measured by number patients with an occurrence of needing an IVC filter placement.
Time frame: From date of procedure through 12 months
Number of Patients Experiencing Adverse Events Classified as Major Bleeding Events During First 12 Months Post-Procedure by Frequency and Severity
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).
Time frame: From post-procedure through 12-months post-procedure
Number of Patients Experiencing VTE (Venus Thromboembolytic Events) During First 12 Months Post-Procedure by Frequency and Severity.
Number of patients experiencing events related to VTE from time of procedure through the first 12 months post-procedure by frequency and severity.
Time frame: From post-procedure through 12-months post-procedure
Diagnosis of Pulmonary Hypertension Diagnosis
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.
Time frame: Analyzed 12 months post-procedure
| Milestone | Retrospective | Prospective |
|---|---|---|
| Started | 991 | 489 |
| Completed | 941 | 251 |
| Not completed | 50 | 238 |
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).
| Percent change | Retrospective | Prospective |
|---|---|---|
| Change in RV/LV Ratio on Echocardiogram (Matched Pairs as Available) | -22.6 ± 20.8 | -22.6 ± 19.9 |
Measured by number of subjects requiring interventions of adjunctive therapies received during post procedure hospitalization through hospital discharge up to 14 days.
| Participants | Retrospective | Prospective |
|---|---|---|
| Continuation of procedure beyond planned time/dose | 7 | 1 |
| Surgical pulmonary embolectomy | 0 | 1 |
| Catheter-assisted embolectomy including thrombus fragmentation or aspiration | 5 | 2 |
| Peripherally administered systemic fibrinolytic therapy | 4 | 0 |
| Other therapy/procedure | 40 | 3 |
Measured by number of patients who underwent interventional therapies prior to the APT procedure and experienced a non or partial response.
| Participants | Retrospective | Prospective |
|---|---|---|
| Peripherally administered systemic fibrinolytic therapy | 9 | 1 |
| Surgical pulmonary embolectomy | 5 | 0 |
| Catheter-assisted embolectomy including fragmentation or aspiration | 19 | 0 |
| Other | 11 | 3 |
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.
| Participants | Retrospective | Prospective |
|---|---|---|
| SAEs related to EKOS device and/or procedure - Severe | 9 | 5 |
| SAEs related to EKOS device and/or procedure - Moderate | 6 | 1 |
| SAEs related to EKOS device and/or procedure - Mild | 1 | 0 |
Number of all-cause mortality that occurred from the start of procedure through 12 months post-procedure.
| Participants | Retrospective | Prospective |
|---|---|---|
| All-cause Mortality During First 12 Months Post-procedure. | 50 | 15 |
Summary of healthcare utilization from date of enrollment through discharge.
| Hours | Retrospective | Prospective |
|---|---|---|
| Healthcare Utilization | 44.2 (27.3 to 64.6) | 41.2 (25.8 to 54.3) |
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.
| percentage change | Retrospective | Prospective |
|---|---|---|
| PEmb-QOL Mean Change at 3 Months | — | -22.52 ± 24.12 |
| PEmb-QOL Mean Change at 12 Months | — | -23.74 ± 24.14 |
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.
| units on a scale | Retrospective | Prospective |
|---|---|---|
| Change in VAS at 3 Months | — | 12.4 ± 24.36 |
| Change in VAS at 12 Months | — | 11.1 ± 21.7 |
| Change in Utility Score at 3 Months | — | 0.20 ± 0.35 |
| Change in Utility Score at 12 Months | — | 0.19 ± 0.31 |
| Change in Misery Score at 3 Months | — | -2.8 ± 4.8 |
| Change in Misery Score at 12 Months | — | -2.7 ± 4.3 |
Measured by number patients with an occurrence of needing an IVC filter placement.
| Participants | Retrospective | Prospective |
|---|---|---|
| Number of Patients Needing an IVC Filter Placement | 50 | 20 |
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).
| Participants | Retrospective | Prospective |
|---|---|---|
| Major Bleeds within 365 days - Mild | 10 | 3 |
| Major Bleeds within 365 days - Moderate | 33 | 8 |
| Major Bleeds within 365 days - Severe | 18 | 3 |
Number of patients experiencing events related to VTE from time of procedure through the first 12 months post-procedure by frequency and severity.
| Participants | Retrospective | Prospective |
|---|---|---|
| VTEs within 365 Days - Mild | 33 | 31 |
| VTEs within 365 Days - Moderate | 15 | 11 |
| VTEs within 365 Days - Severe | 15 | 5 |
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.
| Participants | Retrospective | Prospective |
|---|---|---|
| Diagnosis of Pulmonary Hypertension Diagnosis | 0 | 1 |
Collected over Adverse Events were collected on or after the date of the procedure through 12 months. Data presented are for prospective and retrospective patients through the 12 month follow up visit.. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Retrospective | 50/991 (5%) | 100/991 (10.1%) | 63/991 (6.4%) |
| Prospective | 15/489 (3.1%) | 39/489 (8%) | 40/489 (8.2%) |
| Event | Retrospective | Prospective |
|---|---|---|
| Pulmonary embolismVascular disorders | 12/991 | 7/489 |
| DeathGeneral disorders | 3/991 | 5/489 |
| Cardiac arrestCardiac disorders | 10/991 | 0/489 |
| HaematomaVascular disorders | 7/991 | 0/489 |
| Deep vein thrombosisVascular disorders | 5/991 | 1/489 |
| Gastrointestinal haemorrhageVascular disorders | 5/991 | 1/489 |
| Multiple organ dysfunction syndromeGeneral disorders | 1/991 | 2/489 |
| Neoplasm, malignantNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/991 | 2/489 |
| Pulmonary hypertensionVascular disorders | 1/991 | 2/489 |
| AnaemiaBlood and lymphatic system disorders | 4/991 | 0/489 |
| Event | Retrospective | Prospective |
|---|---|---|
| Deep Vein ThrombosisVascular disorders | 39/991 | 34/489 |
| HaematomaVascular disorders | 24/991 | 6/489 |
| Age, Continuous(years) | Retrospective | Prospective | Total |
|---|---|---|---|
| Median | 62.0 (14 to 93) | 63.0 (20 to 81) | 63.0 (20 to 81) |
| Sex/Gender, Customized(Participants) | Retrospective | Prospective | Total |
|---|---|---|---|
| Male | 486 | 259 | 745 |
| Female | 504 | 230 | 734 |
| No Answer | 1 | 0 | 1 |
| Race/Ethnicity, Customized(Participants) | Retrospective | Prospective | Total |
|---|---|---|---|
| Caucasian | 652 | 296 | 948 |
| African American | 192 | 77 | 269 |
| Other | 13 | 9 | 22 |
| Unknown or Missing | 134 | 117 | 251 |
| Baseline Medical History(Participants) | Retrospective | Prospective | Total |
|---|---|---|---|
| Active Cancer | 79 | 20 | 99 |
| BMI ≥30.0 kg/m² | 642 | 319 | 961 |
| Family History of Venous Thromboembolism | 109 | 71 | 180 |
| History of Cancer in Remission | 116 | 60 | 176 |
| Congestive Heart Failure | 54 | 13 | 67 |
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Boston Scientific Corporation