Trial · NCT03426124
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| 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 | |
| PRIMARY | Number of Patients Experiencing VTE (Venus Thromboembolytic Events) During First 12 Months Post-Procedure by Frequency and Severity. | From post-procedure through 12-months post-procedure | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Diagnosis of Pulmonary Hypertension Diagnosis | Analyzed 12 months post-procedure | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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GET https://conductscience.org/api/trials/v1/NCT03426124/outcomes