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

NCT ID: NCT05444049

Last Updated: 2025-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-08

Study Completion Date

2024-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiac Arrest Cardiopulmonary Arrest Cardiovascular Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

The NEURESCUE device will be used as an adjunct to ACLS.

Group Type EXPERIMENTAL

NEURESCUE device

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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neurescue

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Shavelle, M.D.

Role: PRINCIPAL_INVESTIGATOR

Long Beach Medical Center

Locations

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Long Beach Medical Center

Long Beach, California, United States

Site Status

Countries

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United States

Other Identifiers

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Safestudy3

Identifier Type: -

Identifier Source: org_study_id

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