Cardiac Arrest (CA)ARISE RCTNCT06793033
A Randomized Controlled Study of the NEURESCUE Device as an Adjunct to Advanced Cardiac Life Support
A study testing Advanced Cardiac Life Support (ACLS) and Aortic balloon occlusion (ABO) in people with Cardiac Arrest (CA) and Cardiopulmonary Arrest, run by neurescue at 2 sites in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiac Arrest (CA), Cardiopulmonary Arrest
- What is being tested?
- Advanced Cardiac Life Support (ACLS) and Aortic balloon occlusion (ABO)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 2 sitesGermany
- Study dates
- 7 Jul 2025to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Traumatic cardiac arrest
- Known pregnancy
- Known terminal disease
- Known do-not-attempt-CPR order
- Known opposition to study participation
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites, 2 recruiting
- Recruiting
Charité - Universitätsklinikum Berlin
Berlin, 12203
Carsten Skurk, M.D., +49 030 450 513725, carsten.skurk@dhzc-charite.de
Carsten Skurk, M.D.
- Recruiting
University Hospital Heidelberg
Heidelberg, 69120
Michael Preusch, M.D., +49 151 40044669, Michael.Preusch@med.uni-heidelberg.de
Michael Preusch, M.D.
About this study
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.
Read the 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.
- Conditions
- Cardiac Arrest (CA), Cardiopulmonary Arrest
- Being tested
- Advanced Cardiac Life Support (ACLS), Aortic balloon occlusion (ABO)
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advanced Cardiac Life Support (ACLS)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (Control) | Active comparator | Enrolled subjects randomized into Arm 1 will receive ACLS treatment. Receives: Procedure: Advanced Cardiac Life Support (ACLS) |
| Arm 2 (Intervention) | Experimental | Enrolled subjects randomized into Arm 2 will receive ACLS treatment combined with ABO. Receives: Procedure: Advanced Cardiac Life Support (ACLS); Device: Aortic balloon occlusion (ABO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resuscitation
Subject achieving shockable rhythm or ROSC
Measured: Measured from 10 minutes after randomization to 70 minutes after randomization
Secondary outcomes (6)
Epinephrine
Dosage of epinephrine administered during resuscitation
Measured: 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: 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: 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: 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: 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: Measured at dischage or at 7 days post cardiac arrest, and 90 days post cardiac arrest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start7 Jul 2025
- Primary completionJan 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Arrest (CA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- neurescue
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06793033
- Sponsor's protocol ID
- ARISE RCT
- Acronym
- ARISE RCT
- Status last verified
- Nov 2025
- First submitted
- 20 Jan 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual request
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of the NEURESCUE Device as an Adjunct to Advanced Cardiac Life Support
- ClinicalTrials.gov ID
- NCT06793033
- Acronym / sponsor ID
- ARISE RCT / ARISE RCT
- Conditions
- Cardiac Arrest (CA), Cardiopulmonary Arrest
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- neurescueIndustry (pharma, biotech, devices)
- Study start
- 7 Jul 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 27 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (Control) | Active comparator | Procedure: Advanced Cardiac Life Support (ACLS)Enrolled subjects randomized into Arm 1 will receive ACLS treatment. |
| Arm 2 (Intervention) | Experimental | Procedure: Advanced Cardiac Life Support (ACLS), Device: Aortic balloon occlusion (ABO)Enrolled subjects randomized into Arm 2 will receive ACLS treatment combined with ABO. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Traumatic cardiac arrest
- Known pregnancy
- Known terminal disease
- Known do-not-attempt-CPR order
- Known opposition to study participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Advanced Cardiac Life Support (ACLS)Standard of care Advanced Cardiac Life Support (ACLS) consists of cardiopulmonary resuscitation (CPR), airway management, ventilation and defibrillation. | Procedure or surgery | Arm 1 (Control), Arm 2 (Intervention) |
| 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. | Device | Arm 2 (Intervention) |
Primary outcome
Resuscitation
Time frame: Measured from 10 minutes after randomization to 70 minutes after randomization
Subject achieving shockable rhythm or ROSC
6 secondary outcomes
Epinephrine
Time frame: 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
(S)A(D)E
Time frame: 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
EQ-5D
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Individual participant dataSharing planned: No. Individual request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Advanced Cardiac Life Support (ACLS) and Aortic balloon occlusion (ABO) in people with Cardiac Arrest (CA) and Cardiopulmonary Arrest, run by neurescue at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Preusch, M.D. (+49 151 40044669, Michael.Preusch@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resuscitation (time frame: Measured from 10 minutes after randomization to 70 minutes after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.