Study Results
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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COMPLETED
NA
10 participants
INTERVENTIONAL
2022-08-11
2023-11-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment
The NEURESCUE device will be used as an adjunct to ALS.
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.
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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
79 Years
ALL
No
Sponsors
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neurescue
INDUSTRY
Responsible Party
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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
Universitätsklinikum Heidelberg
Heidelberg, , Germany
Countries
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Other Identifiers
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Safestudy5
Identifier Type: -
Identifier Source: org_study_id
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