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

An In-hospital Feasibility Study of the 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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Cardiac Arrest; Cardiopulmonary Arrest
• Intervention / Treatment: Device: NEURESCUE device

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 12203
    • Charité - Universitätsklinikum Berlin
  • Heidelberg, Germany, 69120
    • Universitätsklinikum Heidelberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Traumatic cardiac arrest
2. Known pregnancy
3. Known terminal disease
4. Known Do-Not-Resuscitate (DNR) order
5. Subjects whose femoral arterial access site cannot accommodate an 8 Fr introducer sheath
6. Subjects currently on mechanical circulatory support

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; The NEURESCUE device will be used as an adjunct to ALS.	Device: NEURESCUE 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Successful balloon inflation within 10 minutes from first vessel puncture	Assessed up to 10 min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of occlusion success		Assessed up to 1 hour
Return of spontaneous circulation (ROSC)	The endpoint is dichotomous (yes/no) for each subject	Assessed up to 1 hour
Change in central blood pressure		At the initiation of balloon inflation compared to two minutes after finalizing balloon inflation
Total cardiopulmonary resuscitation (CPR) time at the screening for enrollment		From initiation of cardiopulmonary resuscitation (CPR) to screening for enrollment
Total ALS time at initiation of the investigational procedure		From initiation of ALS to initiation of the investigational procedure
Time from first vessel puncture to successful sheath insertion		From first needle stick to successful sheath insertion

Collaborators and Investigators

• Sponsor: neurescue
• Investigators: Principal Investigator: Michael Preusch, M.D., University Hospital Heidelberg

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2022
• Primary Completion (Actual): November 29, 2023
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: November 23, 2021
• First Submitted That Met QC Criteria: November 23, 2021
• First Posted (Actual): December 7, 2021

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 3, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest
• Other Study ID Numbers: Safestudy5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No