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NCT Number: NCT06793033

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

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.

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Key information

Conditions

Cardiac Arrest (CA) Cardiopulmonary Arrest Cardiovascular Diseases Heart Arrest Heart Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charité - Universitätsklinikum Berlin, Berlin, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Advanced Cardiac Life Support (ACLS)

Procedure

Standard of care Advanced Cardiac Life Support (ACLS) consists of cardiopulmonary resuscitation (CPR), airway management, ventilation and defibrillation.

Aortic balloon occlusion (ABO)

Device

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.

Primary outcomes

  1. Resuscitation

    Time frame: Measured from 10 minutes after randomization to 70 minutes after randomization

    Subject achieving shockable rhythm or ROSC

Secondary outcomes

  1. Epinephrine

    Time frame: Measured from 10 minutes after randomization to 70 minutes after randomization

    Dosage of epinephrine administered during resuscitation

  2. Procedures

    Time frame: Measured from 10 minutes after randomization to 90 days post cardiac arrest

    Need for any invasive procedures, e.g. surgery, extracorporeal membrane oxygenation (ECMO) or percutaneous coronary intervention (PCI)

  3. (S)A(D)E

    Time frame: Measured from randomization to 90 days post cardiac arrest

    All Anticipated (S)AEs/(S)ADEs and Unanticipated (S)AEs/(S)ADEs

  4. CPC score

    Time frame: Measured at dischage or at 7 days post cardiac arrest, and 90 days post cardiac arrest

    Cerebral Performance Category (CPC) is a five-point scale used to categorize the neurological outcome after cardiac arrest

  5. EQ-5D

    Time frame: Measured 90 days post cardiac arrest

    EQ-5D is a standardized measure of quality of life

  6. Survival

    Time frame: Measured at dischage or at 7 days post cardiac arrest, and 90 days post cardiac arrest

    Survival at discharge or 7 day post cardiac arrest (whichever comes first), and survival at 90 days post cardiac arrest

Study contacts

Contact information is provided by the study sponsor or research team.

Michael Preusch, M.D.

CONTACT

[email protected]

+49 151 40044669‬

Sponsors and collaborators

Lead sponsor

neurescue

Industry

Registry information

Acronym: ARISE RCT

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 27, 2025
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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