Ignite Creation Date:
2025-12-24 @ 8:02 PM
Ignite Modification Date:
2026-01-02 @ 6:31 AM
Study NCT ID:
NCT00485004
Status:
COMPLETED
Last Update Posted:
2012-08-08
First Post:
2007-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Focal In-stent Restenosis After Drug-Eluting Stent
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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-06', 'studyFirstSubmitDate': '2007-06-11', 'studyFirstSubmitQcDate': '2007-06-11', 'lastUpdatePostDateStruct': {'date': '2012-08-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-06-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Binary In-segment Restenosis', 'timeFrame': 'At 9 months angiographic follow-up'}], 'secondaryOutcomes': [{'measure': 'Composite end-point of death, myocardial infarction, or target vessel revascularization', 'timeFrame': 'At 9-month after index procedure'}, {'measure': 'Stent thrombosis', 'timeFrame': 'In-hospital, 30 days, 9 months, and 1year'}, {'measure': 'Late luminal loss', 'timeFrame': 'at 8 month angiographic follow-up'}, {'measure': 'Procedural success defined as achievement of a final diameter stenosis of <30% by QCA using any percutaneous method, without the occurrence of death, Q wave MI, or repeat revascularization of the target lesion', 'timeFrame': 'during the hospital stay'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Coronary artery disease', 'Stent', 'Angioplasty'], 'conditions': ['In Stent Restenosis']}, 'descriptionModule': {'briefSummary': 'To evaluate the optimal management of focal in-stent restenosis after drug-eluting stent implantation with sirolimus-eluting implantation versus cutting balloon angioplasty', 'detailedDescription': 'Following angiography, patients with focal DES restenosis (lesion length ≤ 10mm) with diameter stenosis \\>50% by visual estimation have documented myocardial ischemia or symptoms of angina, and eligible for PCI without any exclusion criteria will be randomized 1:1 to: a) Cypher stent vs. b) Cutting balloon angioplasty. All patients will be followed for 1 year. Angiographic follow-up at 9-months is mandatory.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. The patient must be at least 18 years of age.\n2. Restenosis after drug-eluting stents (\\>50% by visual estimate)\n3. Lesion length \\< 10 mm (focal ISR)\n4. Patients with stable (CCS class 1 to 4) or acute coronary syndromes (unstable angina pectoris Braunwald class IB, IC, IIB, IIC, IIIB, IIIC or NSTEMI) or patients with atypical chest pain or without symptoms but having documented myocardial ischemia, amenable to stent-assisted percutaneous coronary intervention\n5. The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.\n\nExclusion Criteria:\n\n1. The patient has a known hypersensitivity or contraindication to any of the following medications:\n\n * Heparin\n * Aspirin\n * Both Clopidogrel and TIclopidine\n * Sirolimus eluting stent\n * Stainless steel and/or\n * Contrast media (patients with documented sensitivity to contrast which can be effectively pre-medicated with steroids and diphenhydramine \\[e.g. rash\\] may be enrolled. Patients with true anaphylaxis to prior contrast media, however, should not be enrolled).\n2. Systemic (intravenous) Sirolimus use within 12 months.\n3. Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.\n4. History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.\n5. Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.\n6. Current known current platelet count \\<100,000 cells/mm3 or Hgb \\<10 g/dL.\n7. Non-cardiac co-morbid conditions are present with life expectancy \\<1 year or that may result in protocol non-compliance (per site investigator's medical judgment).\n8. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.\n9. Patients with EF\\<30%.\n10. Acute MI patients within symptom onset \\< 12 hours needing primary angioplasty\n11. Creatinine level 3.0mg/dL or dependence on dialysis.\n12. Severe hepatic dysfunction (AST and ALT 3 times upper normal reference values).\n13. Patients with left main stem stenosis and left main in-stent restenosis created by DES(\\>50% by visual estimate)"}, 'identificationModule': {'nctId': 'NCT00485004', 'acronym': 'FOCUS', 'briefTitle': 'Focal In-stent Restenosis After Drug-Eluting Stent', 'organization': {'class': 'OTHER', 'fullName': 'CardioVascular Research Foundation, Korea'}, 'officialTitle': 'FOcal Type In-stent Restenosis After Drug-Eluting Stent Implantation Treated by CUtting Balloon Angioplasty Versus Sirolimus-Eluting Stent', 'orgStudyIdInfo': {'id': '20070041'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cutting balloon', 'description': 'Cutting balloon', 'interventionNames': ['Device: Cutting balloon', 'Device: Sirolimus-eluting stent']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sirolimus-eluting stent', 'description': 'Sirolimus-eluting stent', 'interventionNames': ['Device: Cutting balloon', 'Device: Sirolimus-eluting stent']}], 'interventions': [{'name': 'Cutting balloon', 'type': 'DEVICE', 'description': 'Cutting balloon', 'armGroupLabels': ['Cutting balloon', 'Sirolimus-eluting stent']}, {'name': 'Sirolimus-eluting stent', 'type': 'DEVICE', 'description': 'Sirolimus-eluting stent', 'armGroupLabels': ['Cutting balloon', 'Sirolimus-eluting stent']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bucheon-si', 'country': 'South Korea', 'facility': 'Soonchunhyang University Bucheon Hospital', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'city': 'Choeng Ju', 'country': 'South Korea', 'facility': "Choeng Ju St.Mary's Hospital"}, {'city': 'Chuncheon', 'country': 'South Korea', 'facility': 'Kangwon National University Hospital', 'geoPoint': {'lat': 37.87472, 'lon': 127.73417}}, {'city': 'Daejeon', 'country': 'South Korea', 'facility': 'Chungnam National University Hospital', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'city': 'Gangneung', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.75266, 'lon': 128.87239}}, {'city': 'Gyongju', 'country': 'South Korea', 'facility': 'DongGuk University Gyongju Hospital'}, {'city': 'Jeonju', 'country': 'South Korea', 'facility': 'Chonbuk National University Hospital', 'geoPoint': {'lat': 35.82194, 'lon': 127.14889}}, {'city': 'Kwangju', 'country': 'South Korea', 'facility': 'Kwangju Christian Hospital', 'geoPoint': {'lat': 36.9122, 'lon': 127.1279}}, {'city': 'Pusan', 'country': 'South Korea', 'facility': 'Inje University Pusan Paik Hospital', 'geoPoint': {'lat': 36.3809, 'lon': 128.3681}}, {'city': 'Pyeongchon', 'country': 'South Korea', 'facility': 'Hallym University Sacred Heart Hospital,', 'geoPoint': {'lat': 37.7007, 'lon': 126.932}}, {'zip': '138-736', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Hangang Sacred Heart Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kyungsang University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul Veterans Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Ulsan', 'country': 'South Korea', 'facility': 'Ulsan University Hospital', 'geoPoint': {'lat': 35.53722, 'lon': 129.31667}}], 'overallOfficials': [{'name': 'Seung-Jung Park, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seung-Jung Park', 'class': 'OTHER'}, 'collaborators': [{'name': 'CardioVascular Research Foundation, Korea', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine', 'investigatorFullName': 'Seung-Jung Park', 'investigatorAffiliation': 'CardioVascular Research Foundation, Korea'}}}}