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OpenTrials
Completed

NCT Number: NCT05146661

NEURESCUE Device as an Adjunct to Cardiac Arrest

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

The objective of the study is to investigate the safety and performance of the NEURESCUE device as an adjunct to Advanced Life Support (ALS) 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–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charité - Universitätsklinikum Berlin, Berlin, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥18 and ≤79 years
  • Witnessed cardiac arrest
  • CPR initiated within 7 min of presumed arrest
  • Cardiac arrest not responding to standard ALS
  • Total CPR time ≤ 40 min at the time of screening for enrollment

Exclusion criteria

  • Traumatic cardiac arrest
  • Known pregnancy
  • Known terminal disease
  • Known Do-Not-Resuscitate (DNR) 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 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: At the initiation of balloon inflation compared to two minutes after finalizing balloon inflation

  2. Total cardiopulmonary resuscitation (CPR) time at the screening for enrollment

    Time frame: From initiation of cardiopulmonary resuscitation (CPR) to screening for enrollment

  3. Total ALS time at initiation of the investigational procedure

    Time frame: From initiation of ALS to initiation of the investigational procedure

  4. Time from first vessel puncture to successful sheath insertion

    Time frame: From first needle stick to successful sheath insertion

  5. Rate of occlusion success

    Time frame: Assessed up to 1 hour

  6. 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

An In-hospital Feasibility Study of the NEURESCUE Device as an Adjunct to Cardiac Arrest

Acronym: ARISE-EU

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 7, 2021
Registry last updated
Jan 5, 2024

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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