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NCT03703453 · ClinicalTrials.gov registry record · Early Phase 1
Resuscitative EndoVascular Aortic Occlusion for Maximal Perfusion
A Early Phase 1 study, sponsored by Yale University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 5
- Enrollment target
NCT03703453: Completed Early Phase 1 study, sponsored by Yale University.
NCT03703453 is a Early Phase 1 study that has completed, run by Yale University. The registered enrollment target is 5 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03703453, a Early Phase 1 study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
REBOA is an endovascular technique that is becoming more widely used in the setting of severe trauma. It is a procedure where one uses the seldigner technique to advance a balloon tipped catheter into the femoral artery and then into the aorta. The balloon is then inflated to fully occlude blood flow to the distal aorta. Study investigators hypothesize that this technique may be of use in the setting of medical cardiac arrest. By occluding the aorta and preventing distal blood flow during CPR, physicians might maximize perfusion to the heart and the brain, and promote return of spontaneous circulation and neurologic recovery. Investigators plan to conduct an IDE approved early feasibility study using the ER-REBOA catheter in five patients who are in cardiac arrest of medical (i.e. non-traumatic) etiology. The primary outcomes will be feasibility and safety. Secondary outcomes will focus on procedural performance, hemodynamic response to aortic occlusion, and patient-centered outcome variables. Investigators plan to expand the study to an additional 15 patients if, after the initial five patients, the risk-benefit profile remains favorable.
Primary Outcome
The successful inflation of the aortic balloon at the level of the diaphragm with resultant occlusion of aortic blood flow. The procedure will be considered feasible if aortic balloons are deployed at the level of the diaphragm in at least 70% of patients attempted. The location of the balloon will be confirmed with bedside ultrasound and/or X-ray. Successful aortic occlusion will be confirmed using flow measurements on bedside ultrasound as well as detecting a lack of blood pressure distal to t
Interventions
- DEVICE ER-REBOA catheter
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2020-01-28 |
| Est. Completion | 2021-04-29 |
| Phase | Early Phase 1 |
What the finished NCT03703453 record still lists
NCT03703453 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 1 intervention - of which ER-REBOA catheter is the first listed.
NCT03703453 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03703453 about?
NCT03703453 is a clinical study titled "Resuscitative EndoVascular Aortic Occlusion for Maximal Perfusion". REBOA is an endovascular technique that is becoming more widely used in the setting of severe trauma. It is a procedure where one uses the seldigner technique to advance a balloon tipped catheter into the femoral artery and then into the aorta. The balloon is then inflated to fully occlude blood flo...
What is the current status of trial NCT03703453?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 5 participants. The study started on 2020-01-28. Estimated completion is 2021-04-29.
What interventions are being tested in trial NCT03703453?
The interventions under investigation include: ER-REBOA catheter (DEVICE).
Who is sponsoring clinical trial NCT03703453?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03703453's enrollment target sits among peer trials
5 1888th of 2000 higher than 80 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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