A Randomized Controlled Study of the NEURESCUE Device as an Adjunct to Advanced Cardiac Life Support (ARISE RCT)

Neurescue

Status: Enrolling

Conditions: Cardiopulmonary Arrest; Cardiac Arrest (CA)

Treatments: Device: Aortic balloon occlusion (ABO); Procedure: Advanced Cardiac Life Support (ACLS)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06793033

ARISE RCT

Details and patient eligibility

About

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.

Full description

Subjects will be randomized into two arms: ACLS treatment or ACLS + ABO treatment. Those in the ACLS treatment arm will receive standard of care treatment for cardiac arrest, while those in Arm 2 will receive ACLS in combination with ABO.

The NEURESCUE device is an aortic balloon catheter designed to temporarily occlude the aorta. During the treatment, the NEURESCUE Catheter will be placed in the descending aorta and be connected to the NEURESCUE Assistant. The NEURESCUE Assistant facilitates pressure-regulated inflation and deflation of the balloon.

Throughout the treatment, cardiac rhythm and return of spontaneous circulation (ROSC) will be monitored.

The subject will be monitored for a total of 4 visits, where a 90-days follow-up will account for the last visit.

Enrollment: 84 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• Traumatic cardiac arrest
• Known pregnancy
• Known terminal disease
• Known do-not-attempt-CPR order
• Known opposition to study participation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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84 participants in 2 patient groups

Arm 1 (Control)

Active Comparator group

Description:

Enrolled subjects randomized into Arm 1 will receive ACLS treatment.

Treatment:

Procedure: Advanced Cardiac Life Support (ACLS)

Arm 2 (Intervention)

Experimental group

Description:

Enrolled subjects randomized into Arm 2 will receive ACLS treatment combined with ABO.

Treatment:

Procedure: Advanced Cardiac Life Support (ACLS)

Device: Aortic balloon occlusion (ABO)