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

Cardiovascular Diseases Clinical Trial

— ARISE  

Official title:

A Feasibility Study of the NEURESCUE Device as an Adjunct to In-Hospital Cardiac Arrest

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05444049
• Other study ID #: Safestudy3
• Status: Recruiting
• Phase: N/A
• Start date: December 8, 2022
• Est. completion date: July 2023

Study information

• Verified date: February 2023
• Source: neurescue
• Contact: Habib Frost, M.D.
• Phone: +4553536760
• Email: habib.frost[@]neurescue.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: July 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Arrest
• Cardiopulmonary Arrest
• Cardiovascular Diseases
• Heart Arrest

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Long Beach Medical Center	Long Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
neurescue

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful balloon inflation within 10 minutes from first vessel puncture		Assessed up to 10 min
Secondary	Change in central blood pressure		Assessed up to 1 hour
Secondary	Total ACLS time at initiation of the investigational procedure		Assessed up to 1 hour
Secondary	Time from first vessel puncture to successful sheath insertion		Assessed up to 1 hour
Secondary	Rate of occlusion success		Assessed up to 1 hour
Secondary	Return of spontaneous circulation (ROSC)	The endpoint is dichotomous (yes/no) for each subject	Assessed up to 1 hour