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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Arrest (CA); Cardiopulmonary Arrest
• Intervention / Treatment: Procedure: Advanced Cardiac Life Support (ACLS); Device: Aortic balloon occlusion (ABO)

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael Preusch, M.D.; Phone Number: +49 151 40044669‬; Email: Michael.Preusch@med.uni-heidelberg.de

Study Locations

• Germany
  • Berlin, Germany, 12203
    • Recruiting
    • Charité - Universitätsklinikum Berlin
    • Contact: Carsten Skurk, M.D.; Phone Number: +49 030 450 513725; Email: carsten.skurk@dhzc-charite.de
    • Principal Investigator: Carsten Skurk, M.D.
  • Heidelberg, Germany, 69120
    • Recruiting
    • University Hospital Heidelberg
    • Contact: Michael Preusch, M.D.; Phone Number: +49 151 40044669‬; Email: Michael.Preusch@med.uni-heidelberg.de
    • Principal Investigator: Michael Preusch, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 1 (Control); Enrolled subjects randomized into Arm 1 will receive ACLS treatment.	Procedure: Advanced Cardiac Life Support (ACLS); Standard of care Advanced Cardiac Life Support (ACLS) consists of cardiopulmonary resuscitation (CPR), airway management, ventilation and defibrillation.
Experimental: Arm 2 (Intervention); Enrolled subjects randomized into Arm 2 will receive ACLS treatment combined with ABO.	Procedure: Advanced Cardiac Life Support (ACLS); Standard of care Advanced Cardiac Life Support (ACLS) consists of cardiopulmonary resuscitation (CPR), airway management, ventilation and defibrillation.; Device: Aortic balloon occlusion (ABO); Aortic balloon occlusion (ABO) is a technique that diverts blood flow towards the coronary and cerebral circulation. ABO is investigated as an adjunct to the treatment of cardiac arrest. In this study ABO is performed using the NEURESCUE Catheter, which is inserted through an introducer in the femoral artery, and thereby inserted into the aorta during uninterrupted Advanced Cardiac Life Support (ACLS). The balloon is then temporarily inflated as an adjunct to the treatment of cardiac arrest.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resuscitation	Subject achieving shockable rhythm or ROSC	Measured from 10 minutes after randomization to 70 minutes after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Epinephrine	Dosage of epinephrine administered during resuscitation	Measured from 10 minutes after randomization to 70 minutes after randomization
Procedures	Need for any invasive procedures, e.g. surgery, extracorporeal membrane oxygenation (ECMO) or percutaneous coronary intervention (PCI)	Measured from 10 minutes after randomization to 90 days post cardiac arrest
(S)A(D)E	All Anticipated (S)AEs/(S)ADEs and Unanticipated (S)AEs/(S)ADEs	Measured from randomization to 90 days post cardiac arrest
CPC score	Cerebral Performance Category (CPC) is a five-point scale used to categorize the neurological outcome after cardiac arrest	Measured at dischage or at 7 days post cardiac arrest, and 90 days post cardiac arrest
EQ-5D	EQ-5D is a standardized measure of quality of life	Measured 90 days post cardiac arrest
Survival	Survival at discharge or 7 day post cardiac arrest (whichever comes first), and survival at 90 days post cardiac arrest	Measured at dischage or at 7 days post cardiac arrest, and 90 days post cardiac arrest

Collaborators and Investigators

• Sponsor: neurescue

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: January 20, 2025
• First Submitted That Met QC Criteria: January 20, 2025
• First Posted (Actual): January 27, 2025

Study Record Updates

• Last Update Posted (Actual): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 13, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Arrest; Therapeutics; Patient Care; Health Services; Health Care Facilities Workforce and Services; Resuscitation; Emergency Treatment; Cardiopulmonary Resuscitation; Life Support Care; Advanced Cardiac Life Support
• Other Study ID Numbers: ARISE RCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No