A Randomized Controlled Study of the NEURESCUE Device as an Adjunct to Advanced Cardiac Life Support
NCT ID: NCT06793033
Last Updated: 2025-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
84 participants
INTERVENTIONAL
2025-07-07
2027-03-31
Brief Summary
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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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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm 1 (Control)
Enrolled subjects randomized into Arm 1 will receive ACLS treatment.
Advanced Cardiac Life Support (ACLS)
Standard of care Advanced Cardiac Life Support (ACLS) consists of cardiopulmonary resuscitation (CPR), airway management, ventilation and defibrillation.
Arm 2 (Intervention)
Enrolled subjects randomized into Arm 2 will receive ACLS treatment combined with ABO.
Advanced Cardiac Life Support (ACLS)
Standard of care Advanced Cardiac Life Support (ACLS) consists of cardiopulmonary resuscitation (CPR), airway management, ventilation and defibrillation.
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.
Interventions
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Advanced Cardiac Life Support (ACLS)
Standard of care Advanced Cardiac Life Support (ACLS) consists of cardiopulmonary resuscitation (CPR), airway management, ventilation and defibrillation.
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.
Eligibility Criteria
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Inclusion Criteria
* Witnessed arrest
* CPR initiated within 7 min of arrest
* CPR time less than 40 min at enrollment
* Non-shockable rhythm
Exclusion Criteria
* Known pregnancy
* Known terminal disease
* Known do-not-attempt-CPR order
* Known opposition to study participation
18 Years
80 Years
ALL
No
Sponsors
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neurescue
INDUSTRY
Responsible Party
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Locations
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Charité - Universitätsklinikum Berlin
Berlin, , Germany
University Hospital Heidelberg
Heidelberg, , Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ARISE RCT
Identifier Type: -
Identifier Source: org_study_id
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