NCT06793033

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
10mo left

Started Jul 2025

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress51%
Jul 2025Mar 2027

First Submitted

Initial submission to the registry

January 20, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 27, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

July 7, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

November 17, 2025

Status Verified

November 1, 2025

Enrollment Period

1.5 years

First QC Date

January 20, 2025

Last Update Submit

November 13, 2025

Conditions

Cardiac Arrest (CA)Cardiopulmonary Arrest

Outcome Measures

Primary Outcomes (1)

  • Resuscitation

    Subject achieving shockable rhythm or ROSC

    Measured from 10 minutes after randomization to 70 minutes after randomization

Secondary Outcomes (6)

  • Epinephrine

    Measured from 10 minutes after randomization to 70 minutes after randomization

  • Procedures

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

  • (S)A(D)E

    Measured from randomization to 90 days post cardiac arrest

  • CPC score

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

  • EQ-5D

    Measured 90 days post cardiac arrest

  • +1 more secondary outcomes

Study Arms (2)

Arm 1 (Control)

ACTIVE COMPARATOR

Enrolled subjects randomized into Arm 1 will receive ACLS treatment.

Procedure: Advanced Cardiac Life Support (ACLS)

Arm 2 (Intervention)

EXPERIMENTAL

Enrolled subjects randomized into Arm 2 will receive ACLS treatment combined with ABO.

Procedure: Advanced Cardiac Life Support (ACLS)Device: Aortic balloon occlusion (ABO)

Interventions

Advanced Cardiac Life Support (ACLS)PROCEDURE

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

Arm 1 (Control)Arm 2 (Intervention)
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.

Arm 2 (Intervention)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Traumatic cardiac arrest
  • Known pregnancy
  • Known terminal disease
  • Known do-not-attempt-CPR order
  • Known opposition to study participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Charité - Universitätsklinikum Berlin

Berlin, 12203, Germany

RECRUITING

University Hospital Heidelberg

Heidelberg, 69120, Germany

RECRUITING

MeSH Terms

Conditions

Heart Arrest

Interventions

Advanced Cardiac Life Support

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiopulmonary ResuscitationResuscitationEmergency TreatmentTherapeuticsLife Support CarePatient CareHealth ServicesHealth Care Facilities Workforce and Services

Central Study Contacts

Michael Preusch, M.D.

CONTACT

+49 151 40044669‬Michael.Preusch@med.uni-heidelberg.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2025

First Posted

January 27, 2025

Study Start

July 7, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

November 17, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Individual request

Locations

DE(2)