A Randomized Controlled Study of the NEURESCUE Device as an Adjunct to Advanced Cardiac Life Support
neurescue
84 participants
Jul 7, 2025
INTERVENTIONAL
Conditions
Summary
The NEURESCUE device is the first intelligent balloon catheter for aortic balloon occlusion (ABO), an emergency technique that supercharges blood flow to the heart and brain within one minute from deployment. The catheter-based device is delivered via the femoral artery, temporarily inflating a soft balloon in the descending to redirect blood flow towards the upper body. The purpose of this study is to compare the clinical safety and performance of Advanced Cardiovascular Life Support (ACLS) versus ACLS in combination with Aortic Balloon Occlusion (ABO) using the NEURESCUE device in subjects with cardiac arrest.
Eligibility
Inclusion Criteria5
- Age ≥18 and ≤80 years
- Witnessed arrest
- CPR initiated within 7 min of arrest
- CPR time less than 40 min at enrollment
- Non-shockable rhythm
Exclusion Criteria5
- Traumatic cardiac arrest
- Known pregnancy
- Known terminal disease
- Known do-not-attempt-CPR order
- Known opposition to study participation
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Interventions
Standard of care Advanced Cardiac Life Support (ACLS) consists of cardiopulmonary resuscitation (CPR), airway management, ventilation and defibrillation.
Aortic balloon occlusion (ABO) is a technique that diverts blood flow towards the coronary and cerebral circulation. ABO is investigated as an adjunct to the treatment of cardiac arrest. In this study ABO is performed using the NEURESCUE Catheter, which is inserted through an introducer in the femoral artery, and thereby inserted into the aorta during uninterrupted Advanced Cardiac Life Support (ACLS). The balloon is then temporarily inflated as an adjunct to the treatment of cardiac arrest.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06793033