NEURESCUE Device as an Adjunct to In-Hospital Cardiac Arrest (ARISE) (ARISE)
Primary Purpose
Cardiac Arrest, Cardiopulmonary Arrest, Cardiovascular Diseases
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NEURESCUE device
Sponsored by
About this trial
This is an interventional treatment trial for Cardiac Arrest
Eligibility Criteria
Inclusion Criteria:
- Age ≥18 and ≤70 years
- CPR initiated within 7 min of presumed arrest
- 8 min of continuous ACLS without ROSC
Exclusion Criteria:
- Traumatic cardiac arrest
- Intraoperative cardiac arrest
- Known pregnancy
- Known terminal disease
- Known do-not-attempt-CPR order
- Subjects whose femoral arterial access site cannot accommodate an 8 Fr introducer sheath
- Subjects currently on mechanical circulatory support
Sites / Locations
- Long Beach Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
The NEURESCUE device will be used as an adjunct to ACLS.
Outcomes
Primary Outcome Measures
Successful balloon inflation within 10 minutes from first vessel puncture
Secondary Outcome Measures
Change in central blood pressure
Total ACLS time at initiation of the investigational procedure
Time from first vessel puncture to successful sheath insertion
Rate of occlusion success
Return of spontaneous circulation (ROSC)
The endpoint is dichotomous (yes/no) for each subject
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05444049
Brief Title
NEURESCUE Device as an Adjunct to In-Hospital Cardiac Arrest (ARISE)
Acronym
ARISE
Official Title
A Feasibility Study of the NEURESCUE Device as an Adjunct to In-Hospital Cardiac Arrest
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 8, 2022 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
neurescue
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest, Cardiopulmonary Arrest, Cardiovascular Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
The NEURESCUE device will be used as an adjunct to ACLS.
Intervention Type
Device
Intervention Name(s)
NEURESCUE device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Successful balloon inflation within 10 minutes from first vessel puncture
Time Frame
Assessed up to 10 min
Secondary Outcome Measure Information:
Title
Change in central blood pressure
Time Frame
Assessed up to 1 hour
Title
Total ACLS time at initiation of the investigational procedure
Time Frame
Assessed up to 1 hour
Title
Time from first vessel puncture to successful sheath insertion
Time Frame
Assessed up to 1 hour
Title
Rate of occlusion success
Time Frame
Assessed up to 1 hour
Title
Return of spontaneous circulation (ROSC)
Description
The endpoint is dichotomous (yes/no) for each subject
Time Frame
Assessed up to 1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥18 and ≤80 years
CPR initiated within 7 min of presumed arrest
8 min of continuous ACLS without ROSC
Exclusion Criteria:
Traumatic cardiac arrest
Intraoperative cardiac arrest
Known pregnancy
Known terminal disease
Known do-not-attempt-CPR order
Subjects whose femoral arterial access site cannot accommodate an 8 Fr introducer sheath
Subjects currently on mechanical circulatory support
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Habib Frost, M.D.
Phone
+4553536760
Email
habib.frost@neurescue.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Shavelle, M.D.
Organizational Affiliation
Long Beach Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Long Beach Medical Center
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual request
Learn more about this trial
NEURESCUE Device as an Adjunct to In-Hospital Cardiac Arrest (ARISE)
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