Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2025-12-31 @ 6:18 PM
Study NCT ID:
NCT06793033
Status:
RECRUITING
Last Update Posted:
2025-11-17
First Post:
2025-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized Controlled Study of the NEURESCUE Device as an Adjunct to Advanced Cardiac Life Support
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006323', 'term': 'Heart Arrest'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D022561', 'term': 'Advanced Cardiac Life Support'}], 'ancestors': [{'id': 'D016887', 'term': 'Cardiopulmonary Resuscitation'}, {'id': 'D012151', 'term': 'Resuscitation'}, {'id': 'D004638', 'term': 'Emergency Treatment'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008020', 'term': 'Life Support Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 84}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-13', 'studyFirstSubmitDate': '2025-01-20', 'studyFirstSubmitQcDate': '2025-01-20', 'lastUpdatePostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Resuscitation', 'timeFrame': 'Measured from 10 minutes after randomization to 70 minutes after randomization', 'description': 'Subject achieving shockable rhythm or ROSC'}], 'secondaryOutcomes': [{'measure': 'Epinephrine', 'timeFrame': 'Measured from 10 minutes after randomization to 70 minutes after randomization', 'description': 'Dosage of epinephrine administered during resuscitation'}, {'measure': 'Procedures', 'timeFrame': 'Measured from 10 minutes after randomization to 90 days post cardiac arrest', 'description': 'Need for any invasive procedures, e.g. surgery, extracorporeal membrane oxygenation (ECMO) or percutaneous coronary intervention (PCI)'}, {'measure': '(S)A(D)E', 'timeFrame': 'Measured from randomization to 90 days post cardiac arrest', 'description': 'All Anticipated (S)AEs/(S)ADEs and Unanticipated (S)AEs/(S)ADEs'}, {'measure': 'CPC score', 'timeFrame': 'Measured at dischage or at 7 days post cardiac arrest, and 90 days post cardiac arrest', 'description': 'Cerebral Performance Category (CPC) is a five-point scale used to categorize the neurological outcome after cardiac arrest'}, {'measure': 'EQ-5D', 'timeFrame': 'Measured 90 days post cardiac arrest', 'description': 'EQ-5D is a standardized measure of quality of life'}, {'measure': 'Survival', 'timeFrame': 'Measured at dischage or at 7 days post cardiac arrest, and 90 days post cardiac arrest', 'description': 'Survival at discharge or 7 day post cardiac arrest (whichever comes first), and survival at 90 days post cardiac arrest'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiac Arrest (CA)', 'Cardiopulmonary Arrest']}, 'descriptionModule': {'briefSummary': 'The NEURESCUE device is the first intelligent balloon catheter for aortic balloon occlusion (ABO), 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 purpose of this study is to compare the clinical safety and performance of Advanced Cardiovascular Life Support (ACLS) versus ACLS in combination with Aortic Balloon Occlusion (ABO) using the NEURESCUE device in subjects with cardiac arrest.', 'detailedDescription': 'Subjects will be randomized into two arms: ACLS treatment or ACLS + ABO treatment. Those in the ACLS treatment arm will receive standard of care treatment for cardiac arrest, while those in Arm 2 will receive ACLS in combination with ABO.\n\nThe NEURESCUE device is an aortic balloon catheter designed to temporarily occlude the aorta. During the treatment, the NEURESCUE Catheter will be placed in the descending aorta and be connected to the NEURESCUE Assistant. The NEURESCUE Assistant facilitates pressure-regulated inflation and deflation of the balloon.\n\nThroughout the treatment, cardiac rhythm and return of spontaneous circulation (ROSC) will be monitored.\n\nThe subject will be monitored for a total of 4 visits, where a 90-days follow-up will account for the last visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 and ≤80 years\n* Witnessed arrest\n* CPR initiated within 7 min of arrest\n* CPR time less than 40 min at enrollment\n* Non-shockable rhythm\n\nExclusion Criteria:\n\n* Traumatic cardiac arrest\n* Known pregnancy\n* Known terminal disease\n* Known do-not-attempt-CPR order\n* Known opposition to study participation'}, 'identificationModule': {'nctId': 'NCT06793033', 'acronym': 'ARISE RCT', 'briefTitle': 'A Randomized Controlled Study of the NEURESCUE Device as an Adjunct to Advanced Cardiac Life Support', 'organization': {'class': 'INDUSTRY', 'fullName': 'neurescue'}, 'officialTitle': 'A Randomized Controlled Study of the NEURESCUE Device as an Adjunct to Advanced Cardiac Life Support', 'orgStudyIdInfo': {'id': 'ARISE RCT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 1 (Control)', 'description': 'Enrolled subjects randomized into Arm 1 will receive ACLS treatment.', 'interventionNames': ['Procedure: Advanced Cardiac Life Support (ACLS)']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2 (Intervention)', 'description': 'Enrolled subjects randomized into Arm 2 will receive ACLS treatment combined with ABO.', 'interventionNames': ['Procedure: Advanced Cardiac Life Support (ACLS)', 'Device: Aortic balloon occlusion (ABO)']}], 'interventions': [{'name': 'Advanced Cardiac Life Support (ACLS)', 'type': 'PROCEDURE', 'description': 'Standard of care Advanced Cardiac Life Support (ACLS) consists of cardiopulmonary resuscitation (CPR), airway management, ventilation and defibrillation.', 'armGroupLabels': ['Arm 1 (Control)', 'Arm 2 (Intervention)']}, {'name': 'Aortic balloon occlusion (ABO)', 'type': 'DEVICE', 'description': 'Aortic balloon occlusion (ABO) is a technique that diverts blood flow towards the coronary and cerebral circulation. ABO is investigated as an adjunct to the treatment of cardiac arrest.\n\nIn this study ABO is performed using the NEURESCUE Catheter, which is inserted through an introducer in the femoral artery, and thereby inserted into the aorta during uninterrupted Advanced Cardiac Life Support (ACLS). The balloon is then temporarily inflated as an adjunct to the treatment of cardiac arrest.', 'armGroupLabels': ['Arm 2 (Intervention)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12203', 'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Carsten Skurk, M.D.', 'role': 'CONTACT', 'email': 'carsten.skurk@dhzc-charite.de', 'phone': '+49 030 450 513725'}, {'name': 'Carsten Skurk, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Charité - Universitätsklinikum Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '69120', 'city': 'Heidelberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Michael Preusch, M.D.', 'role': 'CONTACT', 'email': 'Michael.Preusch@med.uni-heidelberg.de', 'phone': '+49 151 40044669\u202c'}, {'name': 'Michael Preusch, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}], 'centralContacts': [{'name': 'Michael Preusch, M.D.', 'role': 'CONTACT', 'email': 'Michael.Preusch@med.uni-heidelberg.de', 'phone': '+49 151 40044669\u202c'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'neurescue', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}