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RECRUITING
NCT06793033
NA

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

Sponsor: neurescue

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

84

Start Date

2025-07-07

Completion Date

2027-03

Last Updated

2025-11-17

Healthy Volunteers

No

Interventions

PROCEDURE

Advanced Cardiac Life Support (ACLS)

Standard of care Advanced Cardiac Life Support (ACLS) consists of cardiopulmonary resuscitation (CPR), airway management, ventilation and defibrillation.

DEVICE

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.

Locations (2)

Charité - Universitätsklinikum Berlin

Berlin, Germany

University Hospital Heidelberg

Heidelberg, Germany