Trial · NCT01166997
ULTrasound Accelerated ThrombolysIs of PulMonAry Embolism
NCT01166997, Phase 3, Completed, Boston Scientific Corporation; results first posted 2016-10-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. ULTrasound Accelerated ThrombolysIs of PulMonAry Embolism. Trials, record NCT01166997. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01166997
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ULTrasound Accelerated ThrombolysIs of PulMonAry Embolism
- NCT number
- NCT01166997
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 59 participants, actual
- Lead sponsor
- Boston Scientific Corporation
- Conditions
- Submassive Pulmonary Embolism
- Interventions
- EkoSonic Endovascular System, Unfractionated heparin
- First posted
- 2010-07-21
- Last updated
- 2021-07-19
- Results first posted
- 2016-10-18
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Reduction of RV/LV Ratio | 24 hours | Change in the end-diastolic RV/LV ratio from baseline to 24 hours by echocardiography. |
| Primary | Major Bleeding and Intracranial Bleeding at 30 Days. | 30 days | Bleeding will be classified as major if it is associated with a fall in the hemoglobin level of at least 2.0 g/dl, transfusion of ≥ 2 units of red blood cells, or involvement of a critical site (e.g., intracranial, intraspinal). To aid in evaluating the relationship of bleeding events to rt-PA administration, they will also be categorized by whether they occurred within 3 days after the initiation of thrombolytic therapy. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Reduction of RV/LV Ratio | 24 hours | Ratio | MEAN | |
| PRIMARY | Major Bleeding and Intracranial Bleeding at 30 Days. | 30 days | participants | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Reduction of RV/LV Ratio | Unfractionated Heparin (UFH) Alone | 0.03 | Standard Deviation 0.16 | Ratio | |
| Reduction of RV/LV Ratio | Unfractionated Heprin + EkoSonic Procedure | 0.30 | Standard Deviation 0.20 | Ratio | |
| Major Bleeding and Intracranial Bleeding at 30 Days. | Ultrasound Accelerated Thrombolysis | 0 | participants | ||
| Major Bleeding and Intracranial Bleeding at 30 Days. | Intravenous Unfractionated Heparin | 0 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Unfractionated Heparin (UFH) Alone | 29 | |
| Overall Study | STARTED | Unfractionated Heparin (UFH) + EkoSonic Procedure | 30 | |
| Overall Study | COMPLETED | Unfractionated Heparin (UFH) Alone | 27 | |
| Overall Study | COMPLETED | Unfractionated Heparin (UFH) + EkoSonic Procedure | 30 | |
| Overall Study | NOT COMPLETED | Unfractionated Heparin (UFH) Alone | 2 | |
| Overall Study | NOT COMPLETED | Unfractionated Heparin (UFH) + EkoSonic Procedure | 0 |
Source ClinicalTrials.gov
Adverse events16
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 | Oedema peripheral | General disorders | Unfractionated Heparin (UFH) Alone | 2 | 29 | |
| other | Oedema peripheral | General disorders | UFH + EkoSonic | 0 | 30 | |
| serious | Postoperative wound infection | Surgical and medical procedures | Unfractionated Heparin (UFH) Alone | 0 | 29 | |
| serious | Postoperative wound infection | Surgical and medical procedures | UFH + EkoSonic | 1 | 30 | |
| serious | Pneumonia | Respiratory, thoracic and mediastinal disorders | Unfractionated Heparin (UFH) Alone | 0 | 29 | |
| serious | Pneumonia | Respiratory, thoracic and mediastinal disorders | UFH + EkoSonic | 1 | 30 | |
| serious | Radius fracture | Musculoskeletal and connective tissue disorders | Unfractionated Heparin (UFH) Alone | 0 | 29 | |
| serious | Radius fracture | Musculoskeletal and connective tissue disorders | UFH + EkoSonic | 1 | 30 | |
| serious | Supraventricular tachycardia | Respiratory, thoracic and mediastinal disorders | Unfractionated Heparin (UFH) Alone | 1 | 29 | |
| serious | Supraventricular tachycardia | Respiratory, thoracic and mediastinal disorders | UFH + EkoSonic | 0 | 30 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Unfractionated Heparin (UFH) Alone | ||
| Total, all-cause mortality | UFH + EkoSonic | ||
| Total, other adverse events | Unfractionated Heparin (UFH) Alone | 2 | 29 |
| Total, other adverse events | UFH + EkoSonic | 0 | 30 |
| Total, serious adverse events | Unfractionated Heparin (UFH) Alone | 4 | 29 |
| Total, serious adverse events | UFH + EkoSonic | 3 | 30 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24226805 | 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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ultrasound Accelerated Thrombolysis vs Intravenous Unfractionated Heparin: Major Bleeding and Intracranial Bleeding at 30 Days. | Trial comparisons |
| Unfractionated Heparin (UFH) Alone vs UFH + EkoSonic: 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/NCT01166997
GET https://conductscience.org/api/trials/v1/NCT01166997/registered