Cardiac Arrest, Cardiopulmonary Arrest, Cardiovascular Diseases
Conditions
Brief summary
The NEURESCUE device is the first intelligent catheter for aortic balloon occlusion, 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 aorta to redirect blood flow towards the upper body. The objective of this study is to investigate the feasibility of the NEURESCUE device as an adjunct to Advanced Cardiac Life Support (ACLS) in adults with cardiac arrest.
Interventions
DEVICENEURESCUE device
The balloon catheter is delivered via the femoral artery, temporarily inflating a soft balloon in the descending aorta to redirect blood flow towards the upper body.
Sponsors
neurescue
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 and ≤80 years 2. CPR initiated within 7 min of presumed arrest 3. 8 min of continuous ACLS without ROSC
Exclusion criteria
1. Traumatic cardiac arrest 2. Intraoperative cardiac arrest 3. Known pregnancy 4. Known terminal disease 5. Known do-not-attempt-CPR order 6. Subjects whose femoral arterial access site cannot accommodate an 8 Fr introducer sheath 7. Subjects currently on mechanical circulatory support
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Successful balloon inflation within 10 minutes from first vessel puncture | Assessed up to 10 min |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in central blood pressure | Assessed up to 1 hour | — |
| Total ACLS time at initiation of the investigational procedure | Assessed up to 1 hour | — |
| Time from first vessel puncture to successful sheath insertion | Assessed up to 1 hour | — |
| Rate of occlusion success | Assessed up to 1 hour | — |
| Return of spontaneous circulation (ROSC) | Assessed up to 1 hour | The endpoint is dichotomous (yes/no) for each subject |
Countries
United States
Outcome results
None listed