Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-30 @ 8:15 PM
Study NCT ID:
NCT00912756
Status:
UNKNOWN
Last Update Posted:
2010-07-22
First Post:
2009-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sufficient Treatment of Peripheral Intervention by Cilostazol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001162', 'term': 'Arteriosclerosis Obliterans'}], 'ancestors': [{'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077407', 'term': 'Cilostazol'}], 'ancestors': [{'id': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2012-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-07-21', 'studyFirstSubmitDate': '2009-06-02', 'studyFirstSubmitQcDate': '2009-06-02', 'lastUpdatePostDateStruct': {'date': '2010-07-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Angiographic restenosis rate', 'timeFrame': '12 months +- 1 month'}], 'secondaryOutcomes': [{'measure': 'Cardiovascular events'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['endovascular therapy', 'restenosis', 'cilostazol', 'femoropopliteal artery lesions', 'Chronic arteriosclerosis obliterans afflicting the femoropopliteal artery area'], 'conditions': ['Arteriosclerosis Obliterans']}, 'referencesModule': {'references': [{'pmid': '29706129', 'type': 'DERIVED', 'citation': 'Soga Y, Hamasaki T, Edahiro R, Iida O, Inoue N, Suzuki K, Yokoi Y, Kawasaki D, Zen K, Urasawa K, Aodo K; STOP-IC investigators. Sustained Effectiveness of Cilostazol After Endovascular Treatment of Femoropopliteal Lesions: Midterm Follow-up From the Sufficient Treatment of Peripheral Intervention by Cilostazol (STOP-IC) Study. J Endovasc Ther. 2018 Jun;25(3):306-312. doi: 10.1177/1526602818771358. Epub 2018 Apr 30.'}, {'pmid': '23652861', 'type': 'DERIVED', 'citation': 'Iida O, Yokoi H, Soga Y, Inoue N, Suzuki K, Yokoi Y, Kawasaki D, Zen K, Urasawa K, Shintani Y, Miyamoto A, Hirano K, Miyashita Y, Tsuchiya T, Shinozaki N, Nakamura M, Isshiki T, Hamasaki T, Nanto S; STOP-IC investigators. Cilostazol reduces angiographic restenosis after endovascular therapy for femoropopliteal lesions in the Sufficient Treatment of Peripheral Intervention by Cilostazol study. Circulation. 2013 Jun 11;127(23):2307-15. doi: 10.1161/CIRCULATIONAHA.112.000711. Epub 2013 May 7.'}]}, 'descriptionModule': {'briefSummary': 'Recently, Nanto et al. reported that cilostazol effectively prevented restenosis in a retrospective analysis of 121 femoropopliteal artery lesions in percutaneous transluminal angioplasty (PTA) patients who had undergone PTA. In a prospective 3-year follow-up study in 127 patients with similar diseases, the patency rate was significantly higher in the cilostazol group than in the ticlopidine group. It was also found that cilostazol markedly inhibited restenosis during the first 1-year period following endovascular therapy when restenosis is most frequently observed. In addition, there have been sporadic reports that cilostazol was effective in preventing post-stenting restenosis in the coronary artery area.\n\nBased on these results, this multicenter study is going to be conducted to prospectively evaluate the usefulness of cilostazol in lower limb endovascular therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Patient criteria:\n\n* Chronic arteriosclerosis obliterans afflicting the femoropopliteal artery area\\*\n* Patients who can be monitored for at least 2 years after surgery\n\nLesion criteria:\n\n* Angiographically-confirmed new significant superficial femoral artery stenosis or occlusive lesions that are 30 cm long or less if stented\n* At least 1 arterial runoff below the knee; stenosis lesions not limiting flow may be included.\n* Occlusive lesions may be included.\n\nExclusion criteria:\n\n* Patients with or at risk of hemorrhagic complications or patients with bleeding tendency\n* Patients with congestive cardiac failure\n* Patients with a drug-eluting stent\n* Patients with acute lower limb ischemia\n* Patients with creatinine of 2 mg/dL or more(without dialysis)\n* patients with a history of serious adverse reaction such as leukopenia, hepatic dysfunction, or renal dysfunction, or hypersensitivity to any component of the study drug.\n\nLesion criteria:\n\n* Remnant inflow\n* Severe calcification\n* No arterial runoff below the knee'}, 'identificationModule': {'nctId': 'NCT00912756', 'acronym': 'STOP-IC', 'briefTitle': 'Sufficient Treatment of Peripheral Intervention by Cilostazol', 'organization': {'class': 'OTHER', 'fullName': 'Kansai Rosai Hospital'}, 'officialTitle': 'Evaluation of Antiplatelet Therapy in Lower Limb Endovascular Treatment', 'orgStudyIdInfo': {'id': 'STOP-IC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1cilostazol', 'description': 'Cilostazol group: Treatment with cilostazol 200 mg/day BID (morning and evening) and aspirin at 100 mg/day will be started 3 to 7 days prior to EVT and continued until the end of the 2-year follow-up period.', 'interventionNames': ['Drug: cilostazol']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2aspirin', 'description': 'Non-cilostazol group: Treatment with aspirin 100 mg/day will be started 3 to 7 days prior to EVT and continued until the end of the 2-year follow-up period.', 'interventionNames': ['Drug: cilostazol']}], 'interventions': [{'name': 'cilostazol', 'type': 'DRUG', 'description': '200 mg/day BID', 'armGroupLabels': ['1cilostazol', '2aspirin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8308577', 'city': 'Kurume', 'state': 'Fukuoka', 'status': 'NOT_YET_RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Shintani Yoshiaki', 'role': 'CONTACT', 'phone': '81-942-38-2222'}], 'facility': 'Shinkoga Hospital', 'geoPoint': {'lat': 33.31667, 'lon': 130.51667}}, {'zip': '663-8501', 'city': 'Nishinomiya', 'state': 'Hyōgo', 'status': 'NOT_YET_RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Daizo Kawasaki', 'role': 'CONTACT', 'phone': '0798-45-6111'}], 'facility': 'Hyogo College of Medicine Hopital', 'geoPoint': {'lat': 34.71562, 'lon': 135.33199}}, {'zip': '920-0007', 'city': 'Kanazawa', 'state': 'Ishikawa-ken', 'status': 'NOT_YET_RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Taketsugu Tsuchiya', 'role': 'CONTACT', 'phone': '81-76-253-8000'}], 'facility': 'Department of Cardiology, Kanazawa Cardiovascular Hospital', 'geoPoint': {'lat': 36.6, 'lon': 136.61667}}, {'zip': '3888004', 'city': 'Nagano', 'state': 'Nagano', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Norihiko Shinozaki', 'role': 'CONTACT', 'phone': '81-26-292-2261'}], 'facility': 'Department of Cardiology,Naganoken Koseiren Shinonoi', 'geoPoint': {'lat': 36.65, 'lon': 138.18333}}, {'zip': '523-0082', 'city': 'Ōmihachiman', 'state': 'Shiga', 'status': 'NOT_YET_RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Kan Zen', 'role': 'CONTACT', 'phone': '81-748-33-3151'}], 'facility': 'Omihachiman Community Medical Center', 'geoPoint': {'lat': 35.12861, 'lon': 136.0976}}, {'city': 'Amagasaki', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Osamu Iida', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kansai Rosai Hospital and seven others', 'geoPoint': {'lat': 34.71667, 'lon': 135.41667}}, {'city': 'Kishiwada', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Yoshiaki Yokoi', 'role': 'CONTACT', 'phone': '81-72-445-9915'}], 'facility': 'Kishiwada Tokushukai Hospital', 'geoPoint': {'lat': 34.46667, 'lon': 135.36667}}, {'city': 'Kitakyusy', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Hiroyoshi Yokoi', 'role': 'CONTACT', 'phone': '81-93-921-2231'}], 'facility': 'Kokura Memorial Hospital'}, {'city': 'Matsumoto', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Yusuke Miyashita', 'role': 'CONTACT', 'phone': '81- 263-35-4600'}], 'facility': 'Shinshu University Hospital', 'geoPoint': {'lat': 36.23333, 'lon': 137.96667}}, {'city': 'Sapporo', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Kazushi Urasawa', 'role': 'CONTACT', 'phone': '81-11-251-1221'}], 'facility': 'Caress Sapporo Tokeidai Memorial Hospital', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Sendai', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Naoto Inoue', 'role': 'CONTACT', 'phone': '81-22-222-6181'}], 'facility': 'Sendai Kousei Hospital', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'city': 'Yokohama', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Akira Miyamoto', 'role': 'CONTACT', 'phone': '81-45-402-7111'}], 'facility': 'Kikuna Memorial Hospital', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'city': 'Yokohama', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Keisuke Hirano', 'role': 'CONTACT', 'phone': '81-45-576-3000'}], 'facility': 'Saiseikai Yokohama- City Eastern Hospital', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}], 'centralContacts': [{'name': 'Osamu Iida', 'role': 'CONTACT', 'phone': '+81-6-6416-1221'}, {'name': 'Shinsuke Nanto', 'role': 'CONTACT', 'phone': '+81-6-6416-1221'}], 'overallOfficials': [{'name': 'Osamu Iida', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kansai Rosai Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kansai Rosai Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Association for Establishment of Ebvidence in Interventions', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Osamu Iida', 'oldOrganization': 'Kansai Rosai Hospital'}}}}