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
1 other identifier
interventional
6
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2022
Typical duration for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
June 28, 2022
CompletedFirst Posted
Study publicly available on registry
July 5, 2022
CompletedStudy Start
First participant enrolled
December 8, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2024
CompletedOctober 9, 2025
October 1, 2024
1.8 years
June 28, 2022
October 7, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Successful balloon inflation within 10 minutes from first vessel puncture
Assessed up to 10 min
Secondary Outcomes (5)
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)
Assessed up to 1 hour
Study Arms (1)
Treatment
EXPERIMENTALThe NEURESCUE device will be used as an adjunct to ACLS.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Age ≥18 and ≤80 years
- CPR initiated within 7 min of presumed arrest
- min of continuous ACLS without ROSC
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- neurescuelead
Study Sites (1)
Long Beach Medical Center
Long Beach, California, 90806, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Shavelle, M.D.
Long Beach Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2022
First Posted
July 5, 2022
Study Start
December 8, 2022
Primary Completion
September 30, 2024
Study Completion
September 30, 2024
Last Updated
October 9, 2025
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share
Individual request