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

Neurescue

Status: Completed

Conditions: Cardiopulmonary Arrest; Cardiovascular Diseases; Cardiac Arrest

Treatments: Device: NEURESCUE device

Study type: Interventional

Funder types: Industry

Identifiers

NCT05146661

Safestudy5

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Treatment

Experimental group

Description:

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

Treatment:

Device: NEURESCUE device