Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2026-02-21 @ 11:18 PM
Study NCT ID:
NCT02981134
Status:
WITHDRAWN
Last Update Posted:
2021-07-23
First Post:
2016-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Usefulness of Coronary CT Scan After Everolimus-eluting Bioabsorbable Scaffold Implantation for Coronary Artery Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'This study will be revived with retrospective design.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-19', 'studyFirstSubmitDate': '2016-11-30', 'studyFirstSubmitQcDate': '2016-11-30', 'lastUpdatePostDateStruct': {'date': '2021-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Computed tomographic scan parameters', 'timeFrame': '3 years', 'description': 'Computed tomographic scan parameters predicting clinical outcomes'}], 'secondaryOutcomes': [{'measure': 'Restenosis', 'timeFrame': '1 year', 'description': 'Restenosis on computed tomographic scan'}, {'measure': 'Thrombosis', 'timeFrame': '1 year', 'description': 'Thrombosis on computed tomographic scan'}, {'measure': 'Lumen loss', 'timeFrame': '1 year', 'description': 'lumen loss: the change in minimal lumen diameter on computed tomographic scan'}, {'measure': 'Positive predictive value', 'timeFrame': '3 years', 'description': 'Positive predictive value on computed tomographic scan'}, {'measure': 'Clinical outcomes', 'timeFrame': '3 years', 'description': 'Death, target vessel myocardial infarction, clinically driven revascularization'}, {'measure': 'Proportion of analyzable lesion', 'timeFrame': '3 years', 'description': 'small vessel defined diameter less than 3.0 mm, bifurcation, overlapped lesion'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['bioabsorbable scaffold', 'computed tomography'], 'conditions': ['Coronary Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate usefulness of coronary computed tomographic scan for prediction of clinical events after everolimus-eluting bioabsorbable scaffold implantation for coronary artery disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated with Bioresobable Vascular Scaffold for coronary disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients treated withBioresobable Vascular Scaffold for coronary disease\n\nExclusion Criteria:\n\n* History of allergy to contrast\n* Serum Creatinine \\> 2.0 mg/dl\n* Severe arrhythmia\n* Pregnancy or breast feeding'}, 'identificationModule': {'nctId': 'NCT02981134', 'acronym': 'CT BVS', 'briefTitle': 'The Usefulness of Coronary CT Scan After Everolimus-eluting Bioabsorbable Scaffold Implantation for Coronary Artery Disease', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'The Usefulness of Coronary CT Scan After Everolimus-eluting Bioabsorbable Scaffold Implantation for Coronary Artery Disease; A Single Center, Prospective Observational Study', 'orgStudyIdInfo': {'id': 'AMCCV2016-25'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'bioabsorbable scaffold', 'description': 'Patients with BVS(bioabsorbable scaffold) for coronary stenosis', 'interventionNames': ['Procedure: Computed tomographic scan']}], 'interventions': [{'name': 'Computed tomographic scan', 'type': 'PROCEDURE', 'description': 'after 1year of BVS implantation, computed tomographic scan will be performed', 'armGroupLabels': ['bioabsorbable scaffold']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jung-min Ahn', 'class': 'OTHER'}, 'collaborators': [{'name': 'CardioVascular Research Foundation, Korea', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant professor, Department of Cardiology, Heart Institute, University of Ulsan College of Medicine', 'investigatorFullName': 'Jung-min Ahn', 'investigatorAffiliation': 'Asan Medical Center'}}}}