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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 is a NA study that has completed, run by Emory University. The registered enrollment target is 18 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03086317
The ClinicalTrials.gov registry entry for NCT03086317 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Standard Catheter-Directed Thrombolysis is the first listed.
NCT03086317 reports 0 study locations.
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.
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