ARISE-EU: NEURESCUE Device as an Adjunct to Cardiac Arrest

• Sponsor: neurescue (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05146661
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 7
• Patients Per Site Per Month: 1.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Arrest; Cardiopulmonary Arrest; Cardiovascular Diseases	Device: NEURESCUE device	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An In-hospital Feasibility Study of the NEURESCUE Device as an Adjunct to Cardiac Arrest
• Anticipated Study Start Date: May 2, 2022
• Anticipated Primary Completion Date: Sep 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment The NEURESCUE device will be used as an adjunct to ALS.	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.

Outcome Measures

Primary Outcome Measures

1. Successful balloon inflation within 10 minutes from first vessel puncture [Assessed up to 10 min]

Secondary Outcome Measures

1. Change in central blood pressure [At the initiation of balloon inflation compared to two minutes after finalizing balloon inflation]

2. Total cardiopulmonary resuscitation (CPR) time at the screening for enrollment [From initiation of cardiopulmonary resuscitation (CPR) to screening for enrollment]

3. Total ALS time at initiation of the investigational procedure [From initiation of ALS to initiation of the investigational procedure]

4. Time from first vessel puncture to successful sheath insertion [From first needle stick to successful sheath insertion]

5. Rate of occlusion success [Assessed up to 1 hour]

6. Return of spontaneous circulation (ROSC) [Assessed up to 1 hour]

   The endpoint is dichotomous (yes/no) for each subject

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitätsklinikum Heidelberg	Heidelberg		Germany	69120

Sponsors and Collaborators

• neurescue

Investigators

• Principal Investigator: Michael Preusch, M.D., University Hospital Heidelberg

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: neurescue
• ClinicalTrials.gov Identifier: NCT05146661
• Other Study ID Numbers: Safestudy5
• First Posted: Dec 7, 2021
• Last Update Posted: May 6, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cardiovascular Diseases; Heart Arrest

Study Results

No Results Posted as of May 6, 2022