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NCT01513759 · ClinicalTrials.gov registry record · Phase 3
Submassive and Massive Pulmonary Embolism Treatment With Ultrasound Accelerated Thrombolysis Therapy
A Phase 3 study, sponsored by Boston Scientific Corporation.
- Completed
- Registry status
- Phase 3
- Development phase
- 150
- Enrollment target
NCT01513759: Completed Phase 3 study, sponsored by Boston Scientific Corporation.
NCT01513759 is a Phase 3 study that has completed, run by Boston Scientific Corporation. The registered enrollment target is 150 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01513759, a Phase 3 study, has completed, sponsored by Boston Scientific Corporation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 150 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if the EKOS EkoSonic® Endovascular Device when used in conjunction with recombinant tissue plasminogen activator (t-PA) as a treatment for acute PE will decrease the ratio of right ventricle (RV) to left ventricle (LV) diameter within 48 =/- 6 hours in participants with massive or submassive PE.
Primary Outcome
Change from baseline in RV diameter/LV diameter ratio was determined by contrast-enhanced chest computed tomography (CT) within 48 +/- 6 hours after initiating ultrasound-accelerated catheter-directed fibrinolysis.
Interventions
- DRUG recombinant tissue plasminogen activator
- DEVICE EKOS EkoSonic Endovascular System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2012-06-07 |
| Est. Completion | 2013-02-17 |
| Phase | Phase 3 |
What the finished NCT01513759 record still lists
NCT01513759 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 2 interventions - of which recombinant tissue plasminogen activator is the first listed.
NCT01513759 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01513759 about?
NCT01513759 is a clinical study titled "Submassive and Massive Pulmonary Embolism Treatment With Ultrasound Accelerated Thrombolysis Therapy". The purpose of this study is to determine if the EKOS EkoSonic® Endovascular Device when used in conjunction with recombinant tissue plasminogen activator (t-PA) as a treatment for acute PE will decrease the ratio of right ventricle (RV) to left ventricle (LV) diameter within 48 =/- 6 hours in parti...
What is the current status of trial NCT01513759?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 150 participants. The study started on 2012-06-07. Estimated completion is 2013-02-17.
What interventions are being tested in trial NCT01513759?
The interventions under investigation include: recombinant tissue plasminogen activator (DRUG), EKOS EkoSonic Endovascular System (DEVICE).
Who is sponsoring clinical trial NCT01513759?
This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01513759's enrollment target sits among peer trials
150 1519th of 2000 higher than 455 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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