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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
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.
Charité - Universitätsklinikum Berlin
Berlin, Germany
Universitätsklinikum Heidelberg
Heidelberg, Germany
Successful balloon inflation within 10 minutes from first vessel puncture
Time frame: Assessed up to 10 min
Change in central blood pressure
Time frame: At the initiation of balloon inflation compared to two minutes after finalizing balloon inflation
Total cardiopulmonary resuscitation (CPR) time at the screening for enrollment
Time frame: From initiation of cardiopulmonary resuscitation (CPR) to screening for enrollment
Total ALS time at initiation of the investigational procedure
Time frame: From initiation of ALS to initiation of the investigational procedure
Time from first vessel puncture to successful sheath insertion
Time frame: From first needle stick to successful sheath insertion
Rate of occlusion success
Time frame: Assessed up to 1 hour
Return of spontaneous circulation (ROSC)
The endpoint is dichotomous (yes/no) for each subject
Time frame: Assessed up to 1 hour
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