NEURESCUE Device as an Adjunct to Cardiac Arrest | NCT05146661

Studies
NEURESCUE Device as an Adjunct to Cardiac Arrest

NCT05146661

Sponsor

neurescue

Status

Completed

Last Update Posted

Jan 5, 2024Actual

Enrollment

10Actual

Phase

Not Applicable

Conditions

Cardiac Arrest
Cardiopulmonary Arrest
Cardiovascular Diseases

Interventions

NEURESCUE device

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 11, 2022Actual

Primary Completion Date

Nov 29, 2023Actual

Completion Date

Nov 30, 2023Actual

First Submitted Date

Nov 23, 2021

First Submission Date that Met QC Criteria

Nov 23, 2021

First Posted Date

Dec 7, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 3, 2024

Last Update Posted Date

Jan 5, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment	Experimental	The NEURESCUE device will be used as an adjunct to ALS.	Device: NEURESCUE device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NEURESCUE device	Device	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Successful balloon inflation within 10 minutes from first vessel puncture		Assessed up to 10 min

Secondary Outcomes

Measure	Description	Time Frame
Change in central blood pressure		At the initiation of balloon inflation compared to two minutes after finalizing balloon inflation
Total cardiopulmonary resuscitation (CPR) time at the screening for enrollment		From initiation of cardiopulmonary resuscitation (CPR) to screening for enrollment

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

79 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael Preusch, M.D.	University Hospital Heidelberg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Charité - Universitätsklinikum Berlin		Berlin		12203	Germany
Universitätsklinikum Heidelberg

IPD Sharing Statement Module

Plan to Share IPD

Description

Individual request

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006323	Heart Arrest
D002318	Cardiovascular Diseases

Ancestor Terms

ID	Term
D006331	Heart Diseases

Browse Leaves

Not provided

Browse Branches

Not provided