Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-28 @ 7:31 PM
Study NCT ID:
NCT04491903
Status:
WITHDRAWN
Last Update Posted:
2021-05-04
First Post:
2020-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
REBOA for Out-of-hospital Cardiac Arrest
Sponsor:
neurescue
Organization:
Study Overview
Official Title:
REBOA for Out-of-hospital Cardiac Arrest
Status:
WITHDRAWN
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Withdrawn
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Cardiac arrest is a major health problem that carries a high mortality rate. Substantial research and development have been put into changing the outcome of cardiac arrest and despite the advent of automated external defibrillators (AED), increase in bystander Cardiopulmonary resuscitation (CPR) and automated CPR devices (ACPR), the proportion of patient survival to hospital discharge has only minimally improved.
The objective is to investigate safety and performance of the Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) procedure as an adjunct to Advanced Life Support (ALS) for treatment of refractory cardiac arrest.
The objective is to investigate safety and performance of the Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) procedure as an adjunct to Advanced Life Support (ALS) for treatment of refractory cardiac arrest.
Detailed Description:
The scope of the study is to collect data on patients with refractory out of hospital cardiac arrest (OHCA) for this feasibility study.
Data collected:
* from enrolment of the patient until hospital arrival
* every 24 hours
* at discharge or 7 days post enrollment
* at 30 days post enrollment
The investigation is initiated to investigate the safety and performance of the REBOA procedure for patients experiencing refractory OHCA.
Data collected:
* from enrolment of the patient until hospital arrival
* every 24 hours
* at discharge or 7 days post enrollment
* at 30 days post enrollment
The investigation is initiated to investigate the safety and performance of the REBOA procedure for patients experiencing refractory OHCA.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: