Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2026-03-09 @ 5:43 AM
Study NCT ID:
NCT01873027
Status:
COMPLETED
Last Update Posted:
2016-07-14
First Post:
2013-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
OPtical Frequency Domain Imaging vs. INtravascular Ultrasound in Percutaneous Coronary InterventiON
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 829}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-13', 'studyFirstSubmitDate': '2013-05-26', 'studyFirstSubmitQcDate': '2013-06-05', 'lastUpdatePostDateStruct': {'date': '2016-07-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Target Vessel Failure (TVF)', 'timeFrame': '12 months after PCI', 'description': 'The composite endpoint comprised of cardiac death, target vessel-related myocardial infarction (MI) and clinically-driven target vessel revascularization (TVR)'}], 'secondaryOutcomes': [{'measure': 'Cardiac death', 'timeFrame': '12 months after PCI'}, {'measure': 'Myocardial Infarction (MI)', 'timeFrame': '12 months after PCI'}, {'measure': 'Clinically-driven Target lesion revascularization (TLR)', 'timeFrame': '12 months after PCI'}, {'measure': 'MACE (composite of cardiac death, MI, TLR)', 'timeFrame': '12 months after PCI'}, {'measure': 'Target Vessel Revascularization (TVR)', 'timeFrame': '12 months after PCI'}, {'measure': 'Stroke', 'timeFrame': '12 months after PCI'}, {'measure': 'Stent thrombosis', 'timeFrame': '12 months after PCI'}, {'measure': 'Binary restenosis', 'timeFrame': '12 months after PCI'}, {'measure': 'Renal dysfunction', 'timeFrame': '8 months after PCI'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Coronary Artery Disease', 'Percutaneous Coronary Intervention', 'Optical Frequency Domain Imaging', 'Intravascular Ultrasound'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '29121226', 'type': 'DERIVED', 'citation': 'Kubo T, Shinke T, Okamura T, Hibi K, Nakazawa G, Morino Y, Shite J, Fusazaki T, Otake H, Kozuma K, Ioji T, Kaneda H, Serikawa T, Kataoka T, Okada H, Akasaka T; OPINION Investigators. Optical frequency domain imaging vs. intravascular ultrasound in percutaneous coronary intervention (OPINION trial): one-year angiographic and clinical results. Eur Heart J. 2017 Nov 7;38(42):3139-3147. doi: 10.1093/eurheartj/ehx351.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this randomized study is to evaluate the impact of Optical frequency domain imaging (OFDI) guidance for Percutaneous Coronay Intervention (PCI) with drug-eluting stent (DES) as compared with Intravascular ultrasound (IVUS) guidance.', 'detailedDescription': 'Optical frequency domain imaging (OFDI) is a novel, high resolution intravascular imaging modality. Intravascular ultrasound (IVUS) is a widely used conventional imaging modality for achieving optimal stent deployment.\n\nThe aim of this randomized study is to evaluate the impact of OFDI guidance for Percutaneous Coronay Intervention (PCI) with drug-eluting stent (DES) as compared with IVUS guidance.\n\nWe will enroll 800 patients with a de novo lesion who will undergo PCI with DES as is routine practice. Patients will be rondomely assigned to either OFDI-guided PCI arm or IVUS-guided PCI arm.\n\nPatients will then have a follow-up contact at the time of hospital discharge, 8 month and 12 month after PCI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a de novo lesion (in the native coronary circulation) and planned to undergo drug-eluting stent implantation for indications according to the Japan and USA guidelines\n* Patients aged between 20 and 85 years old\n* Patients who has provided written informed consent\n\nExclusion Criteria:\n\n* Patients with Acute Myocardial Infarction (AMI) within 3 months\n* Patients with cardiogenic shock\n* Patients with chronic heart failure\n* Patients with renal failure (eGFR \\<= 30 ml/min/1.73 m2 or Serum creatinine level \\>=1.5mg/dL)\n* Patients who are currently enrolled in other clinical trial which has possibility to influence the primary endpoint of OPINION trial.\n* Patients planned use of bare metal stent\n* Patients with 3-vessel diseases\n* Planned surgery within 1 year\n* Patient on dialysis\n* Target lesion such as:\n\n * Left main coronary artery\n * Aorto-Ostial lesion location within 3mm of the aorta junction\n * Chronic total occlusion\n * Small vessel (reference vessel diameter \\<2.5mm)\n * Coronary artery bypass graft'}, 'identificationModule': {'nctId': 'NCT01873027', 'acronym': 'OPINION', 'briefTitle': 'OPtical Frequency Domain Imaging vs. INtravascular Ultrasound in Percutaneous Coronary InterventiON', 'organization': {'class': 'OTHER', 'fullName': 'Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan'}, 'officialTitle': 'OPtical Frequency Domain Imaging vs. INtravascular Ultrasound in Percutaneous Coronary InterventiON (OPINION)', 'orgStudyIdInfo': {'id': 'TRICVD1225'}, 'secondaryIdInfos': [{'id': 'UMIN000010580', 'type': 'REGISTRY', 'domain': 'UMIN Clinical Trials Registry'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OFDI-guided PCI', 'description': '* OFDI-guided PCI and assessment by OFDI at pre-PCI and post-PCI\n* Follow-up contact at the time of hospital discharge, 8 months and 12 months after PCI.', 'interventionNames': ['Device: OFDI']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IVUS-guided PCI', 'description': '* IVUS-guided PCI and assessment by IVUS at pre-PCI and post-PCI\n* Follow-up contact at the time of hospital discharge, 8 months and 12 months after PCI.', 'interventionNames': ['Device: IVUS']}], 'interventions': [{'name': 'OFDI', 'type': 'DEVICE', 'otherNames': ['LUNAWAVE', 'Fastview', 'Biolimus a9-eluting stent (Nobori stent)'], 'description': '* OFDI-guided PCI and assessment by OFDI at pre-PCI and post-PCI\n* Follow-up contact at the time of hospital discharge, 8 months and 12months after PCI', 'armGroupLabels': ['OFDI-guided PCI']}, {'name': 'IVUS', 'type': 'DEVICE', 'otherNames': ['VISIWAVE', 'ViewIT', 'Biolimus A9-eluting stent (Nobori stent)'], 'description': '* IVUS-guided PCI and assessment by IVUS at pre-PCI and post-PCI\n* Follow-up contact at the time of hospital discharge, 8 months and 12months after PCI', 'armGroupLabels': ['IVUS-guided PCI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '641-8510', 'city': 'Wakayama', 'state': 'Wakayama', 'country': 'Japan', 'facility': 'Wakayama Medical University', 'geoPoint': {'lat': 34.23333, 'lon': 135.16667}}], 'overallOfficials': [{'name': 'Takashi Akasaka, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wakayama Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wakayama Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}