Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2026-02-20 @ 11:49 PM
Study NCT ID:
NCT01460966
Status:
COMPLETED
Last Update Posted:
2017-04-20
First Post:
2011-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Distal Protection Device in Patients at High Risk for Distal Embolism in Acute Coronary Syndrome (ACS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2020-04-02', 'releaseDate': '2020-03-19'}], 'estimatedResultsFirstSubmitDate': '2020-03-19'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], 'ancestors': [{'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-19', 'studyFirstSubmitDate': '2011-10-17', 'studyFirstSubmitQcDate': '2011-10-25', 'lastUpdatePostDateStruct': {'date': '2017-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of no-reflow/slow-flow phenomenon after percutaneous coronary intervention (PCI)', 'timeFrame': 'a day'}], 'secondaryOutcomes': [{'measure': 'Rise in CK-MB and troponin I or T the next morning after PCI (Peak of CK too in case of ST-segment elevation myocardial infarction )', 'timeFrame': 'a day'}, {'measure': 'Incidence of clinical events including mortality, major adverse cardiac events, and Hospitalization for heart failure', 'timeFrame': '10months'}, {'measure': 'Improvement of Thrombolysis in Myocardial Infarction (TIMI) flow grade compared with baseline', 'timeFrame': '8-12months'}, {'measure': 'TIMI flow grade', 'timeFrame': '8-12months'}, {'measure': 'Corrected TIMI frame count', 'timeFrame': '8-12months'}, {'measure': 'Myocardial blush grade', 'timeFrame': '8-12months'}, {'measure': 'Incidence of any revascularization', 'timeFrame': '8-12months'}, {'measure': 'Incidence of stent thrombosis', 'timeFrame': '8-12months'}, {'measure': 'Plaque protrusion by IVUS inside the stent', 'timeFrame': '8-12months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Distal protection device', 'Thrombus aspiration', 'Coronary Artery Disease', 'Coronary Disease', 'Acute Coronary Syndrome'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '30077678', 'type': 'DERIVED', 'citation': 'Hibi K, Kozuma K, Sonoda S, Endo T, Tanaka H, Kyono H, Koshida R, Ishihara T, Awata M, Kume T, Tanabe K, Morino Y, Tsukahara K, Ikari Y, Fujii K, Yamasaki M, Yamanaka T, Kimura K, Isshiki T; VAMPIRE 3 Investigators. A Randomized Study of Distal Filter Protection Versus Conventional Treatment During Percutaneous Coronary Intervention in Patients With Attenuated Plaque Identified by Intravascular Ultrasound. JACC Cardiovasc Interv. 2018 Aug 27;11(16):1545-1555. doi: 10.1016/j.jcin.2018.03.021. Epub 2018 Aug 1.'}]}, 'descriptionModule': {'briefSummary': 'Attenuated plaque ≥ 5mm by intravascular ultrasound(IVUS) was reported to be high risk for distal embolism in Acute coronary syndrome(ACS). The purpose of this study is to assess the effect of thrombus aspiration catheter and distal protection device (filter wire; Filtrap™) in the aforementioned subgroup of patients at high risk for distal embolism.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients who were diagnosed as ACS and meet the following criteria.\n\n* Patients with acute myocardial infarction or unstable angina within 2 months from onset.\n* Patients who have severe coronary stenosis which require PCI and in whom attenuated plaque ≥ 5mm (longitudinally) by IVUS before PCI is observed prior to balloon dilatation and stent deployment.\n\nExclusion Criteria:\n\n* Patients who need balloon expansion (including small diameter balloon) for IVUS catheter crossing.\n* Patients who were resuscitated after dead on arrival\n* Graft lesion or in-stent restenosis lesion\n* Patients on dialysis or renal failure (Cr\\>1.5mg/dl).\n* Left main trunk lesion\n* Target vessel size is \\<2.5mm or \\>5mm\n* Ineligible for PCI\n* Lactating and (possibly) pregnant woman or having possibility of pregnant\n* Patients who are considered ineligible by the attending physician'}, 'identificationModule': {'nctId': 'NCT01460966', 'acronym': 'VAMPIRE3', 'briefTitle': 'Assessment of Distal Protection Device in Patients at High Risk for Distal Embolism in Acute Coronary Syndrome (ACS)', 'organization': {'class': 'OTHER', 'fullName': 'Yokohama City University Medical Center'}, 'officialTitle': 'Assessment of Distal Protection Device in Patients at High Risk for Distal Embolism in Acute Coronary Syndrome (ACS)', 'orgStudyIdInfo': {'id': 'D110922004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Filtrap™+ Thrombus aspiration catheter', 'interventionNames': ['Procedure: Filtrap™ + Thrombus aspiration catheter']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Thrombus aspiration catheter', 'interventionNames': ['Procedure: Thrombus aspiration catheter']}], 'interventions': [{'name': 'Filtrap™ + Thrombus aspiration catheter', 'type': 'PROCEDURE', 'description': 'Combination of distal protection device (Filtrap™ )and thrombus aspiration catheter', 'armGroupLabels': ['Filtrap™+ Thrombus aspiration catheter']}, {'name': 'Thrombus aspiration catheter', 'type': 'PROCEDURE', 'description': 'Thrombus aspiration catheter only', 'armGroupLabels': ['Thrombus aspiration catheter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '232-0024', 'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Yokohama City University Medical Center', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}], 'overallOfficials': [{'name': 'Kiyoshi Hibi, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'Yokohama City Universiy Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yokohama City University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Teikyo University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Yokohama City University Medical Center', 'investigatorFullName': 'Kiyoshi Hibi', 'investigatorAffiliation': 'Yokohama City University Medical Center'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2020-03-19', 'type': 'RELEASE'}, {'date': '2020-04-02', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Kiyoshi Hibi, Yokohama City University Medical Center, Yokohama City University Medical Center'}}}}