NEURESCUE Device as an Adjunct to Cardiac Arrest

NCT ID: NCT05146661

Last Updated: 2024-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-11

Study Completion Date

2023-11-30

Brief Summary

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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

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Conditions

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Cardiac Arrest Cardiopulmonary Arrest Cardiovascular Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

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

Group Type EXPERIMENTAL

NEURESCUE device

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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neurescue

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Preusch, M.D.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Heidelberg

Locations

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Charité - Universitätsklinikum Berlin

Berlin, , Germany

Site Status

Universitätsklinikum Heidelberg

Heidelberg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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Safestudy5

Identifier Type: -

Identifier Source: org_study_id

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