A Randomized Controlled Study of the NEURESCUE Device as an Adjunct to Advanced Cardiac Life Support
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- neurescue
- Enrollment
- 84
- Locations
- 2
- Primary Endpoint
- Resuscitation
Study Overview
Brief Summary
The NEURESCUE device is the first intelligent balloon catheter for aortic balloon occlusion (ABO), 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 purpose of this study is to compare the clinical safety and performance of Advanced Cardiovascular Life Support (ACLS) versus ACLS in combination with Aortic Balloon Occlusion (ABO) using the NEURESCUE device in subjects with cardiac arrest.
Detailed Description
Subjects will be randomized into two arms: ACLS treatment or ACLS + ABO treatment. Those in the ACLS treatment arm will receive standard of care treatment for cardiac arrest, while those in Arm 2 will receive ACLS in combination with ABO.
The NEURESCUE device is an aortic balloon catheter designed to temporarily occlude the aorta. During the treatment, the NEURESCUE Catheter will be placed in the descending aorta and be connected to the NEURESCUE Assistant. The NEURESCUE Assistant facilitates pressure-regulated inflation and deflation of the balloon.
Throughout the treatment, cardiac rhythm and return of spontaneous circulation (ROSC) will be monitored.
The subject will be monitored for a total of 4 visits, where a 90-days follow-up will account for the last visit.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥18 and ≤80 years
- •Witnessed arrest
- •CPR initiated within 7 min of arrest
- •CPR time less than 40 min at enrollment
- •Non-shockable rhythm
Exclusion Criteria
- •Traumatic cardiac arrest
- •Known pregnancy
- •Known terminal disease
- •Known do-not-attempt-CPR order
- •Known opposition to study participation
Arms & Interventions
Arm 1 (Control)
Enrolled subjects randomized into Arm 1 will receive ACLS treatment.
Intervention: Advanced Cardiac Life Support (ACLS) (Procedure)
Arm 2 (Intervention)
Enrolled subjects randomized into Arm 2 will receive ACLS treatment combined with ABO.
Intervention: Advanced Cardiac Life Support (ACLS) (Procedure)
Arm 2 (Intervention)
Enrolled subjects randomized into Arm 2 will receive ACLS treatment combined with ABO.
Intervention: Aortic balloon occlusion (ABO) (Device)
Outcomes
Primary Outcomes
Resuscitation
Time Frame: Measured from 10 minutes after randomization to 70 minutes after randomization
Subject achieving shockable rhythm or ROSC
Secondary Outcomes
- EQ-5D(Measured 90 days post cardiac arrest)
- Epinephrine(Measured from 10 minutes after randomization to 70 minutes after randomization)
- Procedures(Measured from 10 minutes after randomization to 90 days post cardiac arrest)
- CPC score(Measured at dischage or at 7 days post cardiac arrest, and 90 days post cardiac arrest)
- (S)A(D)E(Measured from randomization to 90 days post cardiac arrest)
- Survival(Measured at dischage or at 7 days post cardiac arrest, and 90 days post cardiac arrest)