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

Primary Purpose

Cardiac Arrest, Cardiopulmonary Arrest, Cardiovascular Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
NEURESCUE device
Sponsored by
neurescue
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age ≥18 and ≤75 years
  2. Witnessed cardiac arrest
  3. CPR initiated within 7 min of presumed arrest
  4. Cardiac arrest not responding to standard ALS
  5. Total CPR time ≤ 40 min at the time of screening for enrollment

Exclusion Criteria:

  1. Traumatic cardiac arrest
  2. Known pregnancy
  3. Known terminal disease
  4. Known Do-Not-Resuscitate (DNR) order
  5. Subjects whose femoral arterial access site cannot accommodate an 8 Fr introducer sheath
  6. Subjects currently on mechanical circulatory support

Sites / Locations

  • Charité - Universitätsklinikum BerlinRecruiting
  • Universitätsklinikum HeidelbergRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

The NEURESCUE device will be used as an adjunct to ALS.

Outcomes

Primary Outcome Measures

Successful balloon inflation within 10 minutes from first vessel puncture

Secondary Outcome Measures

Change in central blood pressure
Total cardiopulmonary resuscitation (CPR) time at the screening for enrollment
Total ALS 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

First Posted
November 23, 2021
Last Updated
August 9, 2023
Sponsor
neurescue
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1. Study Identification

Unique Protocol Identification Number
NCT05146661
Brief Title
NEURESCUE Device as an Adjunct to Cardiac Arrest
Acronym
ARISE-EU
Official Title
An In-hospital Feasibility Study of the NEURESCUE Device as an Adjunct to Cardiac Arrest
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 11, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
December 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
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The NEURESCUE device is the first intelligent balloon catheter for aortic 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 to redirect blood flow towards the upper body. The objective of the study is to investigate the safety and performance of the NEURESCUE device as an adjunct to Advanced Life Support (ALS) 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 ALS.
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 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
At the initiation of balloon inflation compared to two minutes after finalizing balloon inflation
Title
Total cardiopulmonary resuscitation (CPR) time at the screening for enrollment
Time Frame
From initiation of cardiopulmonary resuscitation (CPR) to screening for enrollment
Title
Total ALS time at initiation of the investigational procedure
Time Frame
From initiation of ALS to initiation of the investigational procedure
Title
Time from first vessel puncture to successful sheath insertion
Time Frame
From first needle stick to successful sheath insertion
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
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥18 and ≤79 years Witnessed cardiac arrest CPR initiated within 7 min of presumed arrest Cardiac arrest not responding to standard ALS Total CPR time ≤ 40 min at the time of screening for enrollment Exclusion Criteria: Traumatic cardiac arrest Known pregnancy Known terminal disease Known Do-Not-Resuscitate (DNR) 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
Michael Preusch, M.D.
Organizational Affiliation
University Hospital Heidelberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité - Universitätsklinikum Berlin
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
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 Cardiac Arrest

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