Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-29 @ 6:17 PM
Study NCT ID:
NCT04837404
Status:
COMPLETED
Last Update Posted:
2023-06-18
First Post:
2021-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound Guided Transfemoral Complex Large-bore PCI Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, multicentre, randomized investigator-initiated trial with a superiority design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 544}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-15', 'studyFirstSubmitDate': '2021-03-01', 'studyFirstSubmitQcDate': '2021-04-06', 'lastUpdatePostDateStruct': {'date': '2023-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients with BARC 2, 3 or 5 access-site related bleeding or vascular complication requiring intervention of the primary femoral access site during index hospitalization.', 'timeFrame': 'up to discharge hospital, on average 24 hours'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients with BARC 2, 3 or 5 access-site related bleeding or vascular complication requiring intervention of the secondary femoral or radial access site during index hospitalization.', 'timeFrame': 'up to discharge hospital, on average 24 hours'}, {'measure': 'Proportion of patients with BARC 2, 3 or 5 access-site related bleeding or vascular complication requiring intervention of the primary femoral access site at 1 month.', 'timeFrame': '1 month'}, {'measure': 'Proportion of patients with BARC 2, 3 or 5 access-site related bleeding or vascular complication requiring intervention of the secondary femoral or radial access site at 1 month', 'timeFrame': '1 month'}, {'measure': 'Proportion of patients with MACE', 'timeFrame': 'up to discharge hospital (on average 24 hours) and at 1 month'}, {'measure': 'Procedural duration', 'timeFrame': 'during PCI procedure'}, {'measure': 'Incidence of first pass puncture', 'timeFrame': 'during PCI procedure'}, {'measure': 'Number of access attempts', 'timeFrame': 'during PCI procedure'}, {'measure': 'Incidence of.accidental venipuncture', 'timeFrame': 'during PCI procedure'}, {'measure': 'Incidence of access below the femoral artery bifurcation (ileofemoral angiogram)', 'timeFrame': 'during PCI procedure'}, {'measure': 'Incidence of vascular complication not requiring intervention of the primary femoral access site', 'timeFrame': 'up to discharge hospital (on average 24 hours) and at 1 month'}, {'measure': 'Incidence of vascular complication not requiring intervention of the secondary femoral or radial access site', 'timeFrame': 'up to discharge hospital (on average 24 hours) and at 1 month'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Complex Coronary Lesions', 'Percutaneous Coronary Intervention']}, 'referencesModule': {'references': [{'pmid': '38742577', 'type': 'DERIVED', 'citation': 'Meijers TA, Nap A, Aminian A, Schmitz T, Dens J, Teeuwen K, van Kuijk JP, van Wely M, Bataille Y, Kraaijeveld AO, Roolvink V, Dambrink JE, Gosselink ATM, Hermanides RS, Ottervanger JP, Tsilingiris I, van den Buijs DMF, van Royen N, van Leeuwen MAH. Ultrasound-guided versus fluoroscopy-guided large-bore femoral access in PCI of complex coronary lesions: the international, multicentre, randomised ULTRACOLOR Trial. EuroIntervention. 2024 Jul 15;20(14):e876-e886. doi: 10.4244/EIJ-D-24-00089.'}]}, 'descriptionModule': {'briefSummary': 'ULTRACOLOR is a randomized multicentre investigator-initiated study to investigate if ultrasound guided femoral access is associated with less clinically relevant access site related bleeding and/or vascular complications requiring intervention as compared to the fluoroscopy guided method for complex PCI with large-bore access.', 'detailedDescription': 'ULTRACOLOR is a prospective, multicentre, randomized investigator-initiated trial designed to enroll 542 subjects with an indication for PCI for complex coronary lesions.\n\nThis study will investigate if ultrasound guided femoral access is associated with less clinically relevant access site related bleeding and/or vascular complications requiring intervention as compared to the fluoroscopy guided method for complex PCI with large-bore access.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Use of the femoral artery for primary or secondary access with ≥ 7 Fr guiding catheter as indication for complex PCI, according to the expertise of the treating physician.\n2. Age 18 years or older.\n\nExclusion Criteria:\n\n1. Inability to obtain informed consent\n2. Contra-indication for femoral access\n3. Cardiogenic shock\n4. ST elevation myocardial infarction'}, 'identificationModule': {'nctId': 'NCT04837404', 'acronym': 'ULTRACOLOR', 'briefTitle': 'Ultrasound Guided Transfemoral Complex Large-bore PCI Trial', 'organization': {'class': 'OTHER', 'fullName': 'Maatschap Cardiologie Zwolle'}, 'officialTitle': 'Ultrasound Guided Transfemoral Complex Large-bore PCI Trial', 'orgStudyIdInfo': {'id': '9343'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'ultrasound guided femoral access', 'description': 'Patients who are planned for complex PCI requiring 7 or more French sheath and guiding catheters. Ultrasound guided femoral access will be used.', 'interventionNames': ['Procedure: Ultrasound guided femoral access for complex PCI']}, {'type': 'OTHER', 'label': 'fluoroscopy guided femoral access', 'description': 'Patients who are planned for complex PCI requiring 7 or more French sheath and guiding catheters. Fluoroscopy guided femoral access will be used.', 'interventionNames': ['Procedure: Fluoroscopy guided femoral access for complex PCI']}], 'interventions': [{'name': 'Ultrasound guided femoral access for complex PCI', 'type': 'PROCEDURE', 'description': 'Ultrasound guided femoral access for complex PCI', 'armGroupLabels': ['ultrasound guided femoral access']}, {'name': 'Fluoroscopy guided femoral access for complex PCI', 'type': 'PROCEDURE', 'description': 'Fluoroscopy guided femoral access for complex PCI', 'armGroupLabels': ['fluoroscopy guided femoral access']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Charleroi', 'country': 'Belgium', 'facility': 'CHU Charleroi', 'geoPoint': {'lat': 50.41136, 'lon': 4.44448}}, {'city': 'Genk', 'country': 'Belgium', 'facility': 'Ziekenhuis Oost Limburg', 'geoPoint': {'lat': 50.965, 'lon': 5.50082}}, {'city': 'Hasselt', 'country': 'Belgium', 'facility': 'Jessa hospital', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}, {'city': 'Essen', 'country': 'Germany', 'facility': 'Elisabeth-Krankenhaus', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Amsterdam UMC', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Eindhoven', 'country': 'Netherlands', 'facility': 'Catharina hospital', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}, {'city': 'Nieuwegein', 'country': 'Netherlands', 'facility': 'St Antonius', 'geoPoint': {'lat': 52.02917, 'lon': 5.08056}}, {'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Radboudumc', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'UMC Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'zip': '8025 AB', 'city': 'Zwolle', 'country': 'Netherlands', 'facility': 'Isala Hospital', 'geoPoint': {'lat': 52.5125, 'lon': 6.09444}}], 'overallOfficials': [{'name': 'Maarten van Leeuwen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Isala'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maatschap Cardiologie Zwolle', 'class': 'OTHER'}, 'collaborators': [{'name': 'Diagram B.V.', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}