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Completed

NCT Number: NCT05444049

NEURESCUE Device as an Adjunct to In-Hospital Cardiac Arrest (ARISE)

The NEURESCUE device is the first intelligent catheter for aortic balloon occlusion, 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 aorta to redirect blood flow towards the upper body.

The objective of this study is to investigate the feasibility of the NEURESCUE device as an adjunct to Advanced Cardiac Life Support (ACLS) in adults with cardiac arrest.

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Key information

Conditions

Cardiac Arrest Cardiopulmonary Arrest Cardiovascular Diseases Heart Arrest Heart Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Long Beach Medical Center

Long Beach, California, 90806, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 and ≤80 years
  • CPR initiated within 7 min of presumed arrest
  • 8 min of continuous ACLS without ROSC

Exclusion criteria

  • Traumatic cardiac arrest
  • Intraoperative cardiac arrest
  • Known pregnancy
  • Known terminal disease
  • Known do-not-attempt-CPR order
  • Subjects whose femoral arterial access site cannot accommodate an 8 Fr introducer sheath
  • Subjects currently on mechanical circulatory support

Treatment and study plan

NEURESCUE device

Device

The balloon catheter is delivered via the femoral artery, temporarily inflating a soft balloon in the descending aorta to redirect blood flow towards the upper body.

Primary outcomes

  1. Successful balloon inflation within 10 minutes from first vessel puncture

    Time frame: Assessed up to 10 min

Secondary outcomes

  1. Change in central blood pressure

    Time frame: Assessed up to 1 hour

  2. Total ACLS time at initiation of the investigational procedure

    Time frame: Assessed up to 1 hour

  3. Time from first vessel puncture to successful sheath insertion

    Time frame: Assessed up to 1 hour

  4. Rate of occlusion success

    Time frame: Assessed up to 1 hour

  5. Return of spontaneous circulation (ROSC)

    Time frame: Assessed up to 1 hour

    The endpoint is dichotomous (yes/no) for each subject

Sponsors and collaborators

Lead sponsor

neurescue

Industry

Registry information

Official study title

A Feasibility Study of the NEURESCUE Device as an Adjunct to In-Hospital Cardiac Arrest

Acronym: ARISE

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 5, 2022
Registry last updated
Oct 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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