Cardiac Arrest, Cardiopulmonary Arrest, Cardiovascular Diseases
Conditions
Brief summary
The NEURESCUE device is the first intelligent balloon catheter for aortic 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 to redirect blood flow towards the upper body. The objective of the study is to investigate the safety and performance of the NEURESCUE device as an adjunct to Advanced Life Support (ALS) 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 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 79 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 and ≤79 years 2. Witnessed cardiac arrest 3. CPR initiated within 7 min of presumed arrest 4. Cardiac arrest not responding to standard ALS 5. Total CPR time ≤ 40 min at the time of screening for enrollment
Exclusion criteria
1. Traumatic cardiac arrest 2. Known pregnancy 3. Known terminal disease 4. Known Do-Not-Resuscitate (DNR) order 5. Subjects whose femoral arterial access site cannot accommodate an 8 Fr introducer sheath 6. 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 |
|---|---|---|
| Total cardiopulmonary resuscitation (CPR) time at the screening for enrollment | From initiation of cardiopulmonary resuscitation (CPR) to screening for enrollment | — |
| Total ALS time at initiation of the investigational procedure | From initiation of ALS to initiation of the investigational procedure | — |
| Change in central blood pressure | At the initiation of balloon inflation compared to two minutes after finalizing balloon inflation | — |
| 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 |
| Time from first vessel puncture to successful sheath insertion | From first needle stick to successful sheath insertion | — |
Countries
Germany
Outcome results
None listed