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

November 13, 2025 updated by: neurescue

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
84

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Germany
      • Berlin, Germany, 12203
        • Recruiting
        • Charité - Universitätsklinikum Berlin
        • Contact:
        • Principal Investigator:
          • Carsten Skurk, M.D.
      • Heidelberg, Germany, 69120
        • Recruiting
        • University Hospital Heidelberg
        • Contact:
        • Principal Investigator:
          • Michael Preusch, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Resuscitation
Time Frame: Measured from 10 minutes after randomization to 70 minutes after randomization
Subject achieving shockable rhythm or ROSC
Measured from 10 minutes after randomization to 70 minutes after randomization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Epinephrine
Time Frame: Measured from 10 minutes after randomization to 70 minutes after randomization
Dosage of epinephrine administered during resuscitation
Measured from 10 minutes after randomization to 70 minutes after randomization
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)
Measured from 10 minutes after randomization to 90 days post cardiac arrest
(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
Measured from randomization to 90 days post cardiac arrest
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
Measured at dischage or at 7 days post cardiac arrest, and 90 days post cardiac arrest
EQ-5D
Time Frame: Measured 90 days post cardiac arrest
EQ-5D is a standardized measure of quality of life
Measured 90 days post cardiac arrest
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
Measured at dischage or at 7 days post cardiac arrest, and 90 days post cardiac arrest

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
neurescue

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 7, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 20, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 27, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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