NEURESCUE Device as an Adjunct to Cardiac Arrest

Study Overview
=================
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.

Official Title
-----------------
An In-hospital Feasibility Study of the NEURESCUE Device as an Adjunct to Cardiac Arrest

Conditions
-----------------
Cardiac Arrest, Cardiopulmonary Arrest, Cardiovascular Diseases

Intervention / Treatment
-----------------
* Device: NEURESCUE device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 and ≤79 years Witnessed cardiac arrest CPR initiated within 7 min of presumed arrest Cardiac arrest not responding to standard ALS Total CPR time ≤ 40 min at the time of screening for enrollment Exclusion Criteria: Traumatic cardiac arrest Known pregnancy Known terminal disease Known Do-Not-Resuscitate (DNR) order Subjects whose femoral arterial access site cannot accommodate an 8 Fr introducer sheath Subjects currently on mechanical circulatory support

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>The NEURESCUE device will be used as an adjunct to ALS. | Device: NEURESCUE device<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful balloon inflation within 10 minutes from first vessel puncture |  | Assessed up to 10 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in central blood pressure |  | At the initiation of balloon inflation compared to two minutes after finalizing balloon inflation | 
| 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 | 
| Time from first vessel puncture to successful sheath insertion |  | From first needle stick to successful sheath insertion | 
| Rate of occlusion success |  | Assessed up to 1 hour | 
| Return of spontaneous circulation (ROSC) | The endpoint is dichotomous (yes/no) for each subject | Assessed up to 1 hour |