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

Not Applicable

Recruiting

• Conditions: Cardiac Arrest; Cardiopulmonary Arrest; Cardiovascular Diseases
• Interventions: Device: NEURESCUE device

• Registration Number: NCT05444049
• Lead Sponsor: neurescue

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-28
• Study First Submitted QC: 2022-06-29
• Study First Posted: 2022-07-05
• Study Start: 2022-12-08
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-16
• Last Update Posted: 2023-02-17
• Primary Completion: 2023-04
• Study Completion: 2023-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	NEURESCUE device	The NEURESCUE device will be used as an adjunct to ACLS.

Primary Outcome Measures

Name	Time	Method
Successful balloon inflation within 10 minutes from first vessel puncture	Assessed up to 10 min

Secondary Outcome Measures

Name	Time	Method
Change in central blood pressure	Assessed up to 1 hour
Rate of occlusion success	Assessed up to 1 hour
Return of spontaneous circulation (ROSC)	Assessed up to 1 hour	The endpoint is dichotomous (yes/no) for each subject
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

Trial Locations

Locations (1)

Long Beach Medical Center; 🇺🇸 Long Beach, California, United States