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

Neurescue

Status: Completed

Conditions: Cardiopulmonary Arrest; Cardiovascular Diseases; Cardiac Arrest

Treatments: Device: NEURESCUE device

Study type: Interventional

Funder types: Industry

Identifiers

NCT05444049

Safestudy3

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Treatment

Experimental group

Description:

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

Treatment:

Device: NEURESCUE device