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

• Sponsor: neurescue (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05444049
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 8
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Arrest; Cardiopulmonary Arrest; Cardiovascular Diseases	Device: NEURESCUE device	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Feasibility Study of the NEURESCUE Device as an Adjunct to In-Hospital Cardiac Arrest
• Anticipated Study Start Date: Jul 1, 2022
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment The NEURESCUE device will be used as an adjunct to ACLS.	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.

Outcome Measures

Primary Outcome Measures

1. Successful balloon inflation within 10 minutes from first vessel puncture [Assessed up to 10 min]

Secondary Outcome Measures

1. Change in central blood pressure [Assessed up to 1 hour]

2. Total ACLS time at initiation of the investigational procedure [Assessed up to 1 hour]

3. Time from first vessel puncture to successful sheath insertion [Assessed up to 1 hour]

4. Rate of occlusion success [Assessed up to 1 hour]

5. Return of spontaneous circulation (ROSC) [Assessed up to 1 hour]

   The endpoint is dichotomous (yes/no) for each subject

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Age ≥18 and ≤70 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Long Beach Medical Center	Long Beach	California	United States	90806

Sponsors and Collaborators

• neurescue

Investigators

• Principal Investigator: David Shavelle, M.D., Long Beach Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: neurescue
• ClinicalTrials.gov Identifier: NCT05444049
• Other Study ID Numbers: Safestudy3
• First Posted: Jul 5, 2022
• Last Update Posted: Jul 5, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Cardiovascular Diseases; Heart Arrest

Study Results

No Results Posted as of Jul 5, 2022