Trial · NCT03426124
An International Pulmonary Embolism Registry Using EKOS
NCT03426124, Completed, Boston Scientific Corporation; results first posted 2023-02-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An International Pulmonary Embolism Registry Using EKOS. Trials, record NCT03426124. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03426124
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An International Pulmonary Embolism Registry Using EKOS
- NCT number
- NCT03426124
- Status
- Completed
- Enrollment
- 1,480 participants, actual
- Lead sponsor
- Boston Scientific Corporation
- Conditions
- Pulmonary Embolism and Thrombosis
- Interventions
- EkoSonic Endovascular System with thrombolytic
- First posted
- 2018-02-08
- Last updated
- 2023-02-22
- Results first posted
- 2023-02-22
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in RV/LV Ratio on Echocardiogram (Matched Pairs as Available) | Baseline to post-procedure (end of procedure through hospital discharge up to 14 days) | 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). |
| Primary | Frequency and Safety Outcomes of Subjects Requiring Interventions of Adjunctive Therapies Post-procedure During Hospitalization. | Post-procedure hospitalization through hospital discharge up to 14 days | Measured by number of subjects requiring interventions of adjunctive therapies received during post procedure hospitalization through hospital discharge up to 14 days. |
| Primary | Number of Patients Who Underwent Interventional Therapies Prior to the APT Procedure and Experienced a Non- or Partial- Response. | From date of enrollment up to or until the placement of the Ekos device, on average 48 hours. | Measured by number of patients who underwent interventional therapies prior to the APT procedure and experienced a non or partial response. |
| Primary | Number of Patients Experiencing a SAEs Related to EKOS Device and/or Procedure During First 12 Months Post-APT Procedure. | From time of APT procedure through 12 months post-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. |
| Primary | All-cause Mortality During First 12 Months Post-procedure. | Start of procedure through 12 months post-procedure. | Number of all-cause mortality that occurred from the start of procedure through 12 months post-procedure. |
| Primary | Healthcare Utilization | Measured as time from ICU admission to ICU discharge in hours (from date of enrollment through 12 months post-procedure). | Summary of healthcare utilization from date of enrollment through discharge. |
| 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 | Measured as percent change in time from baseline assessment at discharge to 3 month and 12 month follow up. | 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. |
| 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. | Reported results include change from baseline to 3 months and 12 months post-procedure for prospective patients. | 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. |
| Primary | Number of Patients Needing an IVC Filter Placement | From date of procedure through 12 months | Measured by number patients with an occurrence of needing an IVC filter placement. |
| Primary | Number of Patients Experiencing Adverse Events Classified as Major Bleeding Events During First 12 Months Post-Procedure by Frequency and Severity | From post-procedure through 12-months post-procedure | 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). |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in RV/LV Ratio on Echocardiogram (Matched Pairs as Available) | Baseline to post-procedure (end of procedure through hospital discharge up to 14 days) | Subjects with matched pairs (pre-procedure echocardiogram and post-procedure echocardiogram through discharge from index hospitalization) have been reported. | Percent change | MEAN |
| PRIMARY | Frequency and Safety Outcomes of Subjects Requiring Interventions of Adjunctive Therapies Post-procedure During Hospitalization. | Post-procedure hospitalization through hospital discharge up to 14 days | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Patients Who Underwent Interventional Therapies Prior to the APT Procedure and Experienced a Non- or Partial- Response. | From date of enrollment up to or until the placement of the Ekos device, on average 48 hours. | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Patients Experiencing a SAEs Related to EKOS Device and/or Procedure During First 12 Months Post-APT Procedure. | From time of APT procedure through 12 months post-procedure. | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | All-cause Mortality During First 12 Months Post-procedure. | Start of procedure through 12 months post-procedure. | Retrospective data to be updated. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Healthcare Utilization | Measured as time from ICU admission to ICU discharge in hours (from date of enrollment through 12 months post-procedure). | Hours | MEDIAN | |
| 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 | Measured as percent change in time from baseline assessment at discharge to 3 month and 12 month follow up. | QOL date were not collected in the retrospective cohort. These questionnaires were only collected prospectively. | percentage change | MEAN |
| 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. | Reported results include change from baseline to 3 months and 12 months post-procedure for prospective patients. | Data for the retrospective cohort were not captured as Quality of Life questionnaires were not Standard of Care at most institutions. | units on a scale | MEAN |
| PRIMARY | Number of Patients Needing an IVC Filter Placement | From date of procedure through 12 months | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Patients Experiencing Adverse Events Classified as Major Bleeding Events During First 12 Months Post-Procedure by Frequency and Severity | From post-procedure through 12-months post-procedure | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group54
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in RV/LV Ratio on Echocardiogram (Matched Pairs as Available) | Retrospective | -22.6 | Standard Deviation 20.8 | Percent change | |
| Change in RV/LV Ratio on Echocardiogram (Matched Pairs as Available) | Prospective | -22.6 | Standard Deviation 19.9 | Percent change | |
| Frequency and Safety Outcomes of Subjects Requiring Interventions of Adjunctive Therapies Post-procedure During Hospitalization. | Retrospective | Continuation of procedure beyond planned time/dose | 7 | Participants | |
| Frequency and Safety Outcomes of Subjects Requiring Interventions of Adjunctive Therapies Post-procedure During Hospitalization. | Prospective | Continuation of procedure beyond planned time/dose | 1 | Participants | |
| Frequency and Safety Outcomes of Subjects Requiring Interventions of Adjunctive Therapies Post-procedure During Hospitalization. | Retrospective | Surgical pulmonary embolectomy | 0 | Participants | |
| Frequency and Safety Outcomes of Subjects Requiring Interventions of Adjunctive Therapies Post-procedure During Hospitalization. | Prospective | Surgical pulmonary embolectomy | 1 | Participants | |
| Frequency and Safety Outcomes of Subjects Requiring Interventions of Adjunctive Therapies Post-procedure During Hospitalization. | Retrospective | Catheter-assisted embolectomy including thrombus fragmentation or aspiration | 5 | Participants | |
| Frequency and Safety Outcomes of Subjects Requiring Interventions of Adjunctive Therapies Post-procedure During Hospitalization. | Prospective | Catheter-assisted embolectomy including thrombus fragmentation or aspiration | 2 | Participants | |
| Frequency and Safety Outcomes of Subjects Requiring Interventions of Adjunctive Therapies Post-procedure During Hospitalization. | Retrospective | Peripherally administered systemic fibrinolytic therapy | 4 | Participants | |
| Frequency and Safety Outcomes of Subjects Requiring Interventions of Adjunctive Therapies Post-procedure During Hospitalization. | Prospective | Peripherally administered systemic fibrinolytic therapy | 0 | Participants |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Retrospective | 991 | |
| Overall Study | STARTED | Prospective | 489 | |
| Overall Study | COMPLETED | Retrospective | 941 | |
| Overall Study | COMPLETED | Prospective | 251 | |
| Overall Study | NOT COMPLETED | Retrospective | 50 | |
| Overall Study | NOT COMPLETED | Prospective | 238 |
Source ClinicalTrials.gov
Adverse events166
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Deep Vein Thrombosis | Vascular disorders | Retrospective | 39 | 991 | |
| other | Deep Vein Thrombosis | Vascular disorders | Prospective | 34 | 489 | |
| other | Haematoma | Vascular disorders | Retrospective | 24 | 991 | |
| other | Haematoma | Vascular disorders | Prospective | 6 | 489 | |
| serious | Anaemia | Blood and lymphatic system disorders | Retrospective | 4 | 991 | |
| serious | Anaemia | Blood and lymphatic system disorders | Prospective | 0 | 489 | |
| serious | Thrombocytopenia | Blood and lymphatic system disorders | Retrospective | 1 | 991 | |
| serious | Thrombocytopenia | Blood and lymphatic system disorders | Prospective | 0 | 489 | |
| serious | Atrial Fibrillation | Cardiac disorders | Retrospective | 0 | 991 | |
| serious | Atrial Fibrillation | Cardiac disorders | Prospective | 0 | 489 |
1 to 10 of 166Source ClinicalTrials.gov
See all 166 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Retrospective | 50 | 991 |
| Total, all-cause mortality | Prospective | 15 | 489 |
| Total, other adverse events | Retrospective | 63 | 991 |
| Total, other adverse events | Prospective | 40 | 489 |
| Total, serious adverse events | Retrospective | 100 | 991 |
| Total, serious adverse events | Prospective | 39 | 489 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38264938 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Retrospective vs Prospective: Diagnosis of Pulmonary Hypertension Diagnosis | Trial comparisons |
| Retrospective vs Prospective: Number of Patients Needing an IVC Filter Placement | Trial comparisons |
| Retrospective vs Prospective: All-cause Mortality During First 12 Months Post-procedure. | Trial comparisons |
| Retrospective vs Prospective: deaths from any cause | Trial comparisons |
| Retrospective vs Prospective: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03426124
GET https://conductscience.org/api/trials/v1/NCT03426124/results?page=2