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

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Long Beach, California, United States, 90806
      • Long Beach Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥18 and ≤80 years
2. CPR initiated within 7 min of presumed arrest
3. 8 min of continuous ACLS without ROSC

Exclusion Criteria:

1. Traumatic cardiac arrest
2. Intraoperative cardiac arrest
3. Known pregnancy
4. Known terminal disease
5. Known do-not-attempt-CPR order
6. Subjects whose femoral arterial access site cannot accommodate an 8 Fr introducer sheath
7. 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 ACLS.	Device: NEURESCUE 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.

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
Change in central blood pressure		Assessed up to 1 hour
Total ACLS time at initiation of the investigational procedure		Assessed up to 1 hour
Time from first vessel puncture to successful sheath insertion		Assessed up to 1 hour
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

Collaborators and Investigators

• Sponsor: neurescue
• Investigators: Principal Investigator: David Shavelle, M.D., Long Beach Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2022
• Primary Completion (Actual): September 30, 2024
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: June 28, 2022
• First Submitted That Met QC Criteria: June 29, 2022
• First Posted (Actual): July 5, 2022

Study Record Updates

• Last Update Posted (Estimated): October 9, 2025
• Last Update Submitted That Met QC Criteria: October 7, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest
• Other Study ID Numbers: Safestudy3

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: Yes
• product manufactured in and exported from the U.S.: No