Health TrialsbyHealthPanel

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

ConditionsCardiac Arrest (CA)Cardiopulmonary Arrest
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
Sponsorneurescue

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 and ≤80 years

Witnessed arrest

CPR initiated within 7 min of arrest

CPR time less than 40 min at enrollment

Disqualifiers

Traumatic cardiac arrest

Known pregnancy

Known terminal disease

Known do-not-attempt-CPR order

Trial design

Design model

Parallel

Treatments tested in this trial

  • Advanced Cardiac Life Support (ACLS)

    Procedure/Surgery

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

  • Aortic balloon occlusion (ABO)

    Device

    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.

Treatment groups

84 Participants
are divided into 2 treatment groups
Group A: Arm 1 (Control)Active comparator 1 intervention
Group B: Arm 2 (Intervention)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Resuscitation

Subject achieving shockable rhythm or ROSC

Time frame
Measured from 10 minutes after randomization to 70 minutes after randomization

Secondary outcomes

1

Epinephrine

Dosage of epinephrine administered during resuscitation

Time frame
Measured from 10 minutes after randomization to 70 minutes after randomization
2

Procedures

Need for any invasive procedures, e.g. surgery, extracorporeal membrane oxygenation (ECMO) or percutaneous coronary intervention (PCI)

Time frame
Measured from 10 minutes after randomization to 90 days post cardiac arrest
3

(S)A(D)E

All Anticipated (S)AEs/(S)ADEs and Unanticipated (S)AEs/(S)ADEs

Time frame
Measured from randomization to 90 days post cardiac arrest
4

CPC score

Cerebral Performance Category (CPC) is a five-point scale used to categorize the neurological outcome after cardiac arrest

Time frame
Measured at dischage or at 7 days post cardiac arrest, and 90 days post cardiac arrest

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

neurescue

Lead sponsor

Source ClinicalTrials.gov
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