NEURESCUE Device as an Adjunct to Cardiac Arrest

Cardiovascular Diseases Clinical Trial

— ARISE-EU  

Official title:

An In-hospital Feasibility Study of the NEURESCUE Device as an Adjunct to Cardiac Arrest

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05146661
• Other study ID #: Safestudy5
• Status: Completed
• Phase: N/A
• Start date: August 11, 2022
• Est. completion date: November 30, 2023

Study information

• Verified date: January 2024
• Source: neurescue
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 30, 2023
• Est. primary completion date: November 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

Inclusion Criteria:

1. Age =18 and =79 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

Related Conditions & MeSH terms

• Cardiac Arrest
• Cardiopulmonary Arrest
• Cardiovascular Diseases
• Heart Arrest

Intervention

Device:
• NEURESCUE 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.

Locations

Country	Name	City	State
Germany	Charité - Universitätsklinikum Berlin	Berlin
Germany	Universitätsklinikum Heidelberg	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
neurescue

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful balloon inflation within 10 minutes from first vessel puncture		Assessed up to 10 min
Secondary	Change in central blood pressure		At the initiation of balloon inflation compared to two minutes after finalizing balloon inflation
Secondary	Total cardiopulmonary resuscitation (CPR) time at the screening for enrollment		From initiation of cardiopulmonary resuscitation (CPR) to screening for enrollment
Secondary	Total ALS time at initiation of the investigational procedure		From initiation of ALS to initiation of the investigational procedure
Secondary	Time from first vessel puncture to successful sheath insertion		From first needle stick to successful sheath insertion
Secondary	Rate of occlusion success		Assessed up to 1 hour
Secondary	Return of spontaneous circulation (ROSC)	The endpoint is dichotomous (yes/no) for each subject	Assessed up to 1 hour