Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Early Phase 1 study that has completed, run by Yale University. The registered enrollment target is 5 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03703453
The ClinicalTrials.gov registry entry for NCT03703453 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ER-REBOA catheter is the first listed.
NCT03703453 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.