NEURESCUE Device as an Adjunct to Cardiac Arrest

NCT05146661 | Completed

• 1 other identifier: Safestudy5
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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.

Conditions

Cardiac Arrest; Cardiopulmonary Arrest; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• Successful balloon inflation within 10 minutes from first vessel puncture

  Assessed up to 10 min

Secondary Outcomes (6)

• 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

• Total ALS time at initiation of the investigational procedure

  From initiation of ALS to initiation of the investigational procedure

• Time from first vessel puncture to successful sheath insertion

  From first needle stick to successful sheath insertion

• Rate of occlusion success

  Assessed up to 1 hour

Study Arms (1)

Treatment

EXPERIMENTAL

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

Device: NEURESCUE device

Interventions

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.

Treatment

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• neurescue: lead

Study Sites (2)

Charité - Universitätsklinikum Berlin

Berlin, 12203, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

MeSH Terms

Conditions

Heart Arrest; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Heart Diseases

Study Officials

• Michael Preusch, M.D.

  University Hospital Heidelberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: December 7, 2021
• Study Start: August 11, 2022
• Primary Completion: November 29, 2023
• Study Completion: November 30, 2023
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)