Ignite Creation Date:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2025-12-25 @ 8:29 PM
Study NCT ID:
NCT00936169
Status:
COMPLETED
Last Update Posted:
2012-02-22
First Post:
2009-07-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Angiography Versus (vs) IVUS Optimisation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 284}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-20', 'studyFirstSubmitDate': '2009-07-08', 'studyFirstSubmitQcDate': '2009-07-08', 'lastUpdatePostDateStruct': {'date': '2012-02-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-procedure Minimal Lumen Diameter (MLD) evaluated by core lab QCA: superiority for the IVUS optimised group.', 'timeFrame': 'Procedure day'}], 'secondaryOutcomes': [{'measure': 'Target lesion revascularisation (TLR) at 9 months: superiority or statistical trend for the IVUS optimized group', 'timeFrame': '9 months'}, {'measure': 'Major adverse cardiac events (MACE) at 9 months: superiority or statistical trend for the IVUS guided group due to lower TLR and no difference in myocardial infarction (MI) or death.', 'timeFrame': '9 months'}, {'measure': 'MACE events at 2 years.', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Patients with at least one complex lesion suitable for implantation of a drug-eluting stent'], 'conditions': ['Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '23237135', 'type': 'DERIVED', 'citation': 'Chieffo A, Latib A, Caussin C, Presbitero P, Galli S, Menozzi A, Varbella F, Mauri F, Valgimigli M, Arampatzis C, Sabate M, Erglis A, Reimers B, Airoldi F, Laine M, Palop RL, Mikhail G, Maccarthy P, Romeo F, Colombo A. A prospective, randomized trial of intravascular-ultrasound guided compared to angiography guided stent implantation in complex coronary lesions: the AVIO trial. Am Heart J. 2013 Jan;165(1):65-72. doi: 10.1016/j.ahj.2012.09.017. Epub 2012 Nov 20.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study id to demonstrate an advantage for intra-vascular ultrasound (IVUS) optimized drug-eluting stent (DES) implantation compared to angiography in complex lesions'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A complex lesion is regarded as a lesion where the operator would expect a lower immediate and long term success rate compared to non-complex lesions (according to the results of Randomized Controlled Trials and from large Registries). The operator must consider the implantation of a drug-eluting stent, feasible and appropriate for this particular complex lesion\n\nExclusion Criteria:\n\n* Contra-indication to dual anti-platelet therapy.\n* Ejection fraction \\<30%.\n* Renal failure (creatinine \\>2 mg/dL).\n* Significant co-morbidity precluding clinical follow-up.\n* Acute myocardial infarction in the 48 hours prior to the procedure.\n* In-stent restenosis\n* Prior brachytherapy\n* Thrombocytopenia \\<100,000\n* Unprotected left main stem stenosis\n* Venous or arterial grafts\n* Recipient of heart transplant\n* A positive pregnancy test in women with child bearing potential\n* Acute infections\n* Major surgery planned which will lead to discontinuation of antiplatelet therapy\n* Patients with prior BMS or DES implanted in the target vessel less than one year prior to the enrollment, including one year from any intercurrent restenotic or thrombotic event\n* Age under 18 years old.\n* There is no maximum number of lesions which can be treated'}, 'identificationModule': {'nctId': 'NCT00936169', 'acronym': 'AVIO', 'briefTitle': 'Angiography Versus (vs) IVUS Optimisation', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS'}, 'officialTitle': 'Angiography vs. IVUS Optimisation: A Multi-Centre European Study of Drug Eluting Stent Implantation', 'orgStudyIdInfo': {'id': 'AVIO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IVUS optimised stent implantation', 'interventionNames': ['Procedure: IVUS optimised DES implantation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'angiographically guided DES implantation', 'interventionNames': ['Procedure: angiographically guided DES implantation']}], 'interventions': [{'name': 'IVUS optimised DES implantation', 'type': 'PROCEDURE', 'description': 'Ivus optimised stent implantation', 'armGroupLabels': ['IVUS optimised stent implantation']}, {'name': 'angiographically guided DES implantation', 'type': 'PROCEDURE', 'description': 'angiographically guided DES implantation', 'armGroupLabels': ['angiographically guided DES implantation']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mediolanum Cardio Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}