Cardiac ArrestARISE-EUNCT05146661
NEURESCUE Device as an Adjunct to Cardiac Arrest
A study testing NEURESCUE device in people with Cardiac Arrest and Cardiopulmonary Arrest, run by neurescue at 2 sites in Germany.
Trial summary
The NEURESCUE device is the first intelligent balloon catheter for aortic occlusion, 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 79 years
- Conditions the study is for
- Cardiac Arrest, Cardiopulmonary Arrest, Cardiovascular Diseases
- What is being tested?
- NEURESCUE device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesGermany
- Study dates
- 11 Aug 2022to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 and ≤79 years
- Witnessed cardiac arrest
- CPR initiated within 7 min of presumed arrest
- Cardiac arrest not responding to standard ALS
- Total CPR time ≤ 40 min at the time of screening for enrollment
Who cannot join
- Traumatic cardiac arrest
- Known pregnancy
- Known terminal disease
- Known Do-Not-Resuscitate (DNR) order
- Subjects whose femoral arterial access site cannot accommodate an 8 Fr introducer sheath
- Subjects currently on mechanical circulatory support
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Charité - Universitätsklinikum Berlin
Berlin, 12203
Universitätsklinikum Heidelberg
Heidelberg, 69120
About this study
Official title: An In-hospital Feasibility Study of the NEURESCUE Device as an Adjunct to Cardiac Arrest
The NEURESCUE device is the first intelligent balloon catheter for aortic occlusion, 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 objective of the study is to investigate the safety and performance of the NEURESCUE device as an adjunct to Advanced Life Support (ALS) in adults with cardiac arrest.
- Being tested
- NEURESCUE device
- Medical subject headings
- Heart Arrest, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEURESCUE deviceDevice
The balloon catheter is delivered via the femoral artery, temporarily inflating a soft balloon in the descending to redirect blood flow towards the upper body.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | The NEURESCUE device will be used as an adjunct to ALS. Receives: Device: NEURESCUE device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful balloon inflation within 10 minutes from first vessel puncture
Measured: Assessed up to 10 min
Secondary outcomes (6)
Change in central blood pressure
Measured: At the initiation of balloon inflation compared to two minutes after finalizing balloon inflation
Total cardiopulmonary resuscitation (CPR) time at the screening for enrollment
Measured: From initiation of cardiopulmonary resuscitation (CPR) to screening for enrollment
Total ALS time at initiation of the investigational procedure
Measured: From initiation of ALS to initiation of the investigational procedure
Time from first vessel puncture to successful sheath insertion
Measured: From first needle stick to successful sheath insertion
Rate of occlusion success
Measured: Assessed up to 1 hour
Return of spontaneous circulation (ROSC)
The endpoint is dichotomous (yes/no) for each subject
Measured: Assessed up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2021
- Study start11 Aug 2022
- Primary completion29 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- neurescue
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Preusch, M.D., Principal investigator, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05146661
- Sponsor's protocol ID
- Safestudy5
- Acronym
- ARISE-EU
- Status last verified
- Jan 2024
- First submitted
- 23 Nov 2021
- Last updated
- 5 Jan 2024
- 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 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An In-hospital Feasibility Study of the NEURESCUE Device as an Adjunct to Cardiac Arrest
- ClinicalTrials.gov ID
- NCT05146661
- Acronym / sponsor ID
- ARISE-EU / Safestudy5
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- neurescueIndustry (pharma, biotech, devices)
- Study start
- 11 Aug 2022 (actual)
- Primary completion
- 29 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 7 Dec 2021 (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 occlusion, 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 objective of the study is to investigate the safety and performance of the NEURESCUE device as an adjunct to Advanced Life Support (ALS) in adults with cardiac arrest.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: NEURESCUE deviceThe NEURESCUE device will be used as an adjunct to ALS. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 and ≤79 years
- Witnessed cardiac arrest
- CPR initiated within 7 min of presumed arrest
- Cardiac arrest not responding to standard ALS
- Total CPR time ≤ 40 min at the time of screening for enrollment
Key exclusion criteria (6 listed)
- Traumatic cardiac arrest
- Known pregnancy
- Known terminal disease
- Known Do-Not-Resuscitate (DNR) order
- Subjects whose femoral arterial access site cannot accommodate an 8 Fr introducer sheath
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 |
|---|---|---|
| NEURESCUE deviceThe balloon catheter is delivered via the femoral artery, temporarily inflating a soft balloon in the descending to redirect blood flow towards the upper body. | Device | Treatment |
Primary outcome
Successful balloon inflation within 10 minutes from first vessel puncture
Time frame: Assessed up to 10 min
6 secondary outcomes
Change in central blood pressure
Time frame: At the initiation of balloon inflation compared to two minutes after finalizing balloon inflation
Total cardiopulmonary resuscitation (CPR) time at the screening for enrollment
Time frame: From initiation of cardiopulmonary resuscitation (CPR) to screening for enrollment
Total ALS time at initiation of the investigational procedure
Time frame: From initiation of ALS to initiation of the investigational procedure
Time from first vessel puncture to successful sheath insertion
Time frame: From first needle stick to successful sheath insertion
Rate of occlusion success
Time frame: Assessed up to 1 hour
Return of spontaneous circulation (ROSC)
Time frame: Assessed up to 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- 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. This study is not recruiting at the moment.
Michael Preusch, M.D. principal investigator
University Hospital Heidelberg
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NEURESCUE device in people with Cardiac Arrest 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 6 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: finished, as of the sponsor's last update on 5 Jan 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful balloon inflation within 10 minutes from first vessel puncture (time frame: Assessed up to 10 min). 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 5 Jan 2024.