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NCT03086317 · ClinicalTrials.gov registry record · NA
Standard vs Ultrasound-assisted Catheter Thrombolysis for Submassive Pulmonary Embolism
A NA study, sponsored by Emory University.
- Completed
- Registry status
- NA
- Development phase
- 18
- Enrollment target
NCT03086317: Completed NA study, sponsored by Emory University.
NCT03086317 is a NA study that has completed, run by Emory University. The registered enrollment target is 18 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03086317, a NA study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- NA
- Development phase
- 18 participants
- Enrollment target
Study Summary
The study is an investigator-initiated trial comparing two different catheters (standard versus ultrasound assisted) for the treatment of acute high risk pulmonary embolism (blood clots in lung arteries with evidence or heart strain). Patients already planned for the procedure will be randomized to standard catheter-directed thrombolysis (CDT) or to ultrasound-assisted catheter thrombolysis (USAT). Both catheters are currently used routinely in practice for the treatment of pulmonary embolism, but it is not known if USAT is superior to standard CDT, the former being much more expensive and more commonly used. The purpose of the study is to learn about which catheter-directed therapy is more suitable for patients with pulmonary embolism (PE), who are candidates for both standard catheter directed therapy (CDT), and ultrasound-assisted catheter directed therapy (USAT), and to provide information regarding the cost effectiveness of the two different types of treatment. A total of 80 patients are planned to be recruited. All medication administration, procedures or in-hospital tests will be performed as routine clinical practice. The study will compare short term and long term outcomes: resolution of blood clots on CT scan, right ventricular size improvement, quality of life and symptoms at 3 and 12 months, and cost effectiveness.
Primary Outcome
Computed tomography angiography (CTA) will be performed before and after treatment. An independent radiologist will quantify the degree of obstruction from the thrombus by determining the vascular obstruction index. For determining the CT obstruction index, the arterial tree of each lung will be considered to have 10 segmental arteries (three to the upper lobes, two to both the middle lobe and the lingula, and five to the lower lobes).
Interventions
- DEVICE Standard Catheter-Directed Thrombolysis
- DEVICE Ultrasound-Accelerated Thrombolysis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2017-10-19 |
| Est. Completion | 2020-12-08 |
| Phase | NA |
What the finished NCT03086317 record still lists
NCT03086317 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Standard Catheter-Directed Thrombolysis is the first listed.
NCT03086317 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03086317 about?
NCT03086317 is a clinical study titled "Standard vs Ultrasound-assisted Catheter Thrombolysis for Submassive Pulmonary Embolism". The study is an investigator-initiated trial comparing two different catheters (standard versus ultrasound assisted) for the treatment of acute high risk pulmonary embolism (blood clots in lung arteries with evidence or heart strain). Patients already planned for the procedure will be randomized to ...
What is the current status of trial NCT03086317?
This trial is currently completed. It is a NA study. The enrollment target is 18 participants. The study started on 2017-10-19. Estimated completion is 2020-12-08.
What interventions are being tested in trial NCT03086317?
The interventions under investigation include: Standard Catheter-Directed Thrombolysis (DEVICE), Ultrasound-Accelerated Thrombolysis (DEVICE).
Who is sponsoring clinical trial NCT03086317?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03086317's enrollment target sits among peer trials
18 1863rd of 2000 higher than 130 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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