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

Not Applicable

Not yet recruiting

• Conditions: Cardiac Arrest (CA); Cardiopulmonary Arrest

• Registration Number: NCT06793033
• Lead Sponsor: neurescue

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.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-20
• Study First Submitted QC: 2025-01-20
• Study First Posted: 2025-01-27
• Study Start: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-22
• Primary Completion: 2027-01
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 84

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Resuscitation	Measured from 10 minutes after randomization to 70 minutes after randomization	Subject achieving shockable rhythm or ROSC

Secondary Outcome Measures

Name	Time	Method
Epinephrine	Measured from 10 minutes after randomization to 70 minutes after randomization	Dosage of epinephrine administered during resuscitation
Procedures	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)
CPC score	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
(S)A(D)E	Measured from randomization to 90 days post cardiac arrest	All Anticipated (S)AEs/(S)ADEs and Unanticipated (S)AEs/(S)ADEs
EQ-5D	Measured 90 days post cardiac arrest	EQ-5D is a standardized measure of quality of life
Survival	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

Trial Locations

Locations (2)

Charité - Universitätsklinikum Berlin; 🇩🇪 Berlin, Germany

University Hospital Heidelberg; 🇩🇪 Heidelberg, Germany