Clinical trial NCT06793033: A Randomized Controlled Study of the NEURESCUE Device as an Adjunct to Advanced Cardiac Life Support
Official title: A Randomized Controlled Study of the NEURESCUE Device as an Adjunct to Advanced Cardiac Life Support
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiac Arrest (CA)
Cardiopulmonary Arrest
Lead sponsor: neurescue
Sponsor class: INDUSTRY
First posted: 2025-01-27
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Resuscitation
timeFrame: Measured from 10 minutes after randomization to 70 minutes after randomization
Secondary outcomes:
measure: Epinephrine
timeFrame: Measured from 10 minutes after randomization to 70 minutes after randomization
measure: Procedures
timeFrame: Measured from 10 minutes after randomization to 90 days post cardiac arrest
measure: (S)A(D)E
timeFrame: Measured from randomization to 90 days post cardiac arrest
measure: CPC score
timeFrame: Measured at dischage or at 7 days post cardiac arrest, and 90 days post cardiac arrest
measure: EQ-5D
timeFrame: Measured 90 days post cardiac arrest
measure: Survival
timeFrame: Measured at dischage or at 7 days post cardiac arrest, and 90 days post cardiac arrest
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - Universitätsklinikum Berlin
city: Heidelberg
country: Germany
facility: University Hospital Heidelberg
Study officials:
References: