Ignite Creation Date:
2025-12-24 @ 12:20 PM
Ignite Modification Date:
2025-12-27 @ 9:16 PM
Study NCT ID:
NCT05146661
Status:
COMPLETED
Last Update Posted:
2024-01-05
First Post:
2021-11-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NEURESCUE Device as an Adjunct to Cardiac Arrest
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-03', 'studyFirstSubmitDate': '2021-11-23', 'studyFirstSubmitQcDate': '2021-11-23', 'lastUpdatePostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Successful balloon inflation within 10 minutes from first vessel puncture', 'timeFrame': 'Assessed up to 10 min'}], 'secondaryOutcomes': [{'measure': 'Change in central blood pressure', 'timeFrame': 'At the initiation of balloon inflation compared to two minutes after finalizing balloon inflation'}, {'measure': 'Total cardiopulmonary resuscitation (CPR) time at the screening for enrollment', 'timeFrame': 'From initiation of cardiopulmonary resuscitation (CPR) to screening for enrollment'}, {'measure': 'Total ALS time at initiation of the investigational procedure', 'timeFrame': 'From initiation of ALS to initiation of the investigational procedure'}, {'measure': 'Time from first vessel puncture to successful sheath insertion', 'timeFrame': 'From first needle stick to successful sheath insertion'}, {'measure': 'Rate of occlusion success', 'timeFrame': 'Assessed up to 1 hour'}, {'measure': 'Return of spontaneous circulation (ROSC)', 'timeFrame': 'Assessed up to 1 hour', 'description': 'The endpoint is dichotomous (yes/no) for each subject'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiac Arrest', 'Cardiopulmonary Arrest', 'Cardiovascular Diseases']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥18 and ≤79 years\n2. Witnessed cardiac arrest\n3. CPR initiated within 7 min of presumed arrest\n4. Cardiac arrest not responding to standard ALS\n5. Total CPR time ≤ 40 min at the time of screening for enrollment\n\nExclusion Criteria:\n\n1. Traumatic cardiac arrest\n2. Known pregnancy\n3. Known terminal disease\n4. Known Do-Not-Resuscitate (DNR) order\n5. Subjects whose femoral arterial access site cannot accommodate an 8 Fr introducer sheath\n6. Subjects currently on mechanical circulatory support'}, 'identificationModule': {'nctId': 'NCT05146661', 'acronym': 'ARISE-EU', 'briefTitle': 'NEURESCUE Device as an Adjunct to Cardiac Arrest', 'organization': {'class': 'INDUSTRY', 'fullName': 'neurescue'}, 'officialTitle': 'An In-hospital Feasibility Study of the NEURESCUE Device as an Adjunct to Cardiac Arrest', 'orgStudyIdInfo': {'id': 'Safestudy5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'The NEURESCUE device will be used as an adjunct to ALS.', 'interventionNames': ['Device: NEURESCUE device']}], 'interventions': [{'name': 'NEURESCUE device', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12203', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité - Universitätsklinikum Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '69120', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Universitätsklinikum Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}], 'overallOfficials': [{'name': 'Michael Preusch, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Heidelberg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'neurescue', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}