Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-01-01 @ 8:43 AM
Study NCT ID:
NCT02900456
Status:
UNKNOWN
Last Update Posted:
2017-11-14
First Post:
2016-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Intra-Aortic Balloon Pumps Insertion Registry on Behalf of the Groupe Des Angioplasticiens de la Région Ouest
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 177}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2018-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-11-13', 'studyFirstSubmitDate': '2016-08-26', 'studyFirstSubmitQcDate': '2016-09-08', 'lastUpdatePostDateStruct': {'date': '2017-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IABP insertion rate', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Number of cardiogenic shock', 'timeFrame': '1 year', 'description': 'IABP indications'}, {'measure': 'Number of mechanical complication of acute coronary syndrome', 'timeFrame': '1 year', 'description': 'IABP indications'}, {'measure': 'Number of myocardial infarction not shocked', 'timeFrame': '1 year', 'description': 'IABP indications'}, {'measure': 'Number of other indications', 'timeFrame': '1 year', 'description': 'IABP indications'}, {'measure': 'Survival rate following IABP insertion', 'timeFrame': '1 year'}, {'measure': 'IABP-related complications rate and type', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Intra-aortic Balloon Pumps', 'Registry'], 'conditions': ['Interventional Cardiology']}, 'descriptionModule': {'briefSummary': 'Intra-aortic Balloon Pumps (IABP) have been used for roughly 50 years in Critical Care Units, Intensive Care Units, Cath labs as a way to improve systemic and coronary circulation in patients in cardiogenic shock (CS) or at high risk situation as mechanical complications stemming from myocardial infarction (MI), critical coronary stenosis, high-risk PCI, etc. Several papers recently questioned the relevance of this assistance device - namely the IABP-SHOCK II trial in CS and the CRISP-AMI trial in anterior MI without CS - resulting in the downgrading of the recommendation standards of the IABP by medical societies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Intra-aortic Balloon Pumps in patients in cardiogenic shock (CS) or at high risk situation as mechanical complications stemming from myocardial infarction (MI), critical coronary stenosis, high-risk PCI, etc', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females at least of 18 of age;\n* Undergoing IABP treatment ;\n* Subject, relatives or legal guardian signified their non-opposition to participate in the study\n\nExclusion Criteria:\n\n\\- IABP insertion in immediate post-intervention period'}, 'identificationModule': {'nctId': 'NCT02900456', 'acronym': 'CP-GARO', 'briefTitle': 'The Intra-Aortic Balloon Pumps Insertion Registry on Behalf of the Groupe Des Angioplasticiens de la Région Ouest', 'organization': {'class': 'OTHER', 'fullName': 'Rennes University Hospital'}, 'officialTitle': 'The Intra-Aortic Balloon Pumps Insertion Registry on Behalf of the Groupe Des Angioplasticiens de la Région Ouest', 'orgStudyIdInfo': {'id': '35RC14_8942'}}, 'contactsLocationsModule': {'locations': [{'city': 'Angers', 'country': 'France', 'facility': 'CHU Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'city': 'Angers', 'country': 'France', 'facility': 'Clinique Saint Joseph', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'city': 'Brest', 'country': 'France', 'facility': 'CHU Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'city': 'Caen', 'country': 'France', 'facility': 'CHU Caen', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Caen', 'country': 'France', 'facility': 'Hôpital Prive Saint Martin', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Chartres', 'country': 'France', 'facility': 'CH Chartres', 'geoPoint': {'lat': 48.44685, 'lon': 1.48925}}, {'city': 'Laval', 'country': 'France', 'facility': 'CH Laval', 'geoPoint': {'lat': 48.07247, 'lon': -0.77019}}, {'city': 'Le Mans', 'country': 'France', 'facility': 'CH Le Mans', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}, {'city': 'Lorient', 'country': 'France', 'facility': 'CH Bretagne Sud', 'geoPoint': {'lat': 47.74817, 'lon': -3.37177}}, {'city': 'Nantes', 'country': 'France', 'facility': 'CHU Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Nantes', 'country': 'France', 'facility': 'Nouvelles Cliniques Nantaises', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Quimper', 'country': 'France', 'facility': 'CH Intercommunal de Cornouaille', 'geoPoint': {'lat': 47.99597, 'lon': -4.09795}}, {'city': 'Rennes', 'country': 'France', 'facility': 'CHU Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Rennes', 'country': 'France', 'facility': 'Hôpital privé Beauregard', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Rennes', 'country': 'France', 'facility': 'Polyclinique Saint-Laurent', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Rouen', 'country': 'France', 'facility': 'CHU Rouen', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'city': 'Rouen', 'country': 'France', 'facility': 'Clinique Saint-Hilaire', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'city': 'Saint-Brieuc', 'country': 'France', 'facility': 'CH Saint-Brieuc', 'geoPoint': {'lat': 48.51513, 'lon': -2.76838}}, {'city': 'Saint-Nazaire', 'country': 'France', 'facility': 'CH Saint-Nazaire', 'geoPoint': {'lat': 47.27506, 'lon': -2.2179}}, {'city': 'Saint-Nazaire', 'country': 'France', 'facility': 'Groupement Coopération Sanitaire Pui Cite Sanitaire', 'geoPoint': {'lat': 47.27506, 'lon': -2.2179}}, {'city': 'St-Malo', 'country': 'France', 'facility': 'Communauté Hospitalière de Territoire Rance Emeraude', 'geoPoint': {'lat': 48.64738, 'lon': -2.00877}}, {'city': 'Toulon', 'country': 'France', 'facility': 'Polyclinique Les Fleurs', 'geoPoint': {'lat': 43.12442, 'lon': 5.92836}}, {'city': 'Tours', 'country': 'France', 'facility': 'CHU Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'city': 'Tours', 'country': 'France', 'facility': 'Clinique Saint Gatien', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'city': 'Vannes', 'country': 'France', 'facility': 'CH Bretagne Atlantique', 'geoPoint': {'lat': 47.65688, 'lon': -2.76205}}], 'overallOfficials': [{'name': 'Guillaume LEURENT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Rennes'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rennes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}