[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100419496":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":32,"locations":42,"responsibleParty":72,"collaborators":74,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":10,"enrollmentInfo":87,"targetDuration":90,"studyType":91,"phases":10,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":45,"whyStopped":10,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"National Heart Centre Singapore","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Eligible subjects who underwent RA prior to PCI (with informed consent taken to join the study)",null,"Informed consent to be obtained either prior to PCI with rotational atherectomy planned or within 48 hours after rotational atherectomy. There will be data collection of history\u002Fdemographics, laboratory results, symptoms, any serious adverse events recording for this cohort as well as a telephone follow up at 12months post rotational atherectomy.",[13],"Procedure: Rotational Atherectomy",{"label":15,"type":10,"description":16,"interventionNames":17},"Eligible subjects who underwent RA prior to PCI (without informed consent taken to join the study)","Subjects that were demised or refused to give consent will fall under this cohort. The data collection of this cohort will be done through screening of in-hospital data via available local PCI database\u002Fregistry.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"PROCEDURE","Rotational Atherectomy","Rotational atherectomy (RA) has been the most used atherectomy modality since its first inception in1988. RA uses high speed rotation (140,000 - 180,000 rpm) to ablate inelastic plaque, resulting in debris averaging 5µm in size24. The main focus of RA in the era of DES stent has been on plaque modification rather that plaque debulking with more papers showing improved PCI success rates.",[9,15],[25,29],{"name":26,"affiliation":27,"role":28},"Khung Keong Yeo","Singhealth Foundation","PRINCIPAL_INVESTIGATOR",{"name":30,"affiliation":31,"role":28},"Shoichi Kuramitsu","Kokura Memorial Hospital",[33,38],{"name":34,"role":35,"phone":36,"phoneExt":10,"email":37},"James Low","CONTACT","67042280","james.low.j.y@nhcs.com.sg",{"name":39,"role":35,"phone":40,"phoneExt":10,"email":41},"Phoebe Chin","67042268","chin.ting.ting@nhcs.com.sg",[43,58],{"facility":44,"status":45,"city":46,"state":10,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Kokura Memorial hospital","RECRUITING","Kitakyushu","802-8555","Japan","JP",{"type":51,"coordinates":52},"Point",[53,54],130.85034,33.85181,{"lat":54,"lon":53},[57],{"name":30,"role":28,"phone":10,"phoneExt":10,"email":10},{"facility":5,"status":45,"city":59,"state":10,"zip":60,"country":59,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"Singapore","169609","SG",{"type":51,"coordinates":63},[64,65],103.85007,1.28967,{"lat":65,"lon":64},[68,70,71],{"name":34,"role":35,"phone":69,"phoneExt":10,"email":10},"81285063",{"name":39,"role":35,"phone":10,"phoneExt":10,"email":10},{"name":26,"role":28,"phone":10,"phoneExt":10,"email":10},{"type":73,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[75],{"name":76,"class":77},"Boston Scientific Corporation","INDUSTRY","100419496","rovus-asia-registry-evaluate-safety-and-effectiveness-of-rotational-atherectomy-and-intravascular-ultrasound-for-heavily-calcified-coronary-lesion-100419496",false,"NCT04742478","ROVUS Asia Registry (Evaluate Safety and Effectiveness of Rotational Atherectomy and Intravascular Ultrasound for Heavily Calcified Coronary Lesion)","ROVUS","Inclusion Criteria:\n\n* Able to understand and sign an informed consent form\n* Presence of clinical indication for percutaneous coronary intervention (PCI) and\u002For stent placement\n* Subjects willing to comply with all research and follow-up requirements.\n* Angiographic criteria (ONE of the following criteria MUST be met)\n\n  1. Target lesions visually have at least moderate calcifications\\*\n  2. Target lesion balloon dilatation failure\n  3. Inability of devices (microcatheters, balloons or stents) to pass through the target lesion.\n* Procedural criteria\n\n  1. All patients treated with RA with or without other forms of debulking therapy\n\n     * Moderate calcification is defined as radio-opacities noted only during cardiac cycle prior to contrast injection whereas severe calcification is defined as radio-opacities seen without cardiac motion prior to contrast injection, usually affecting both sides of the arterial lumen.\n\nExclusion Criteria:\n\n* Decline to give consent","ALL","21 Years",{"count":88,"type":89},1000,"ESTIMATED","1 Year","OBSERVATIONAL","Rotablation with or without other calcium debulking therapies is a safe adjunctive procedure for patients with severe coronary calcification requiring Percutaneous Coronary Intervention (PCI).",[94],"Coronary Artery Calcification",[96,97,21],"Atherosclerotic Calcification","Medial Artery Calcification","2021-04-21",{"date":100,"type":101},"2021-04-23","ACTUAL",{"date":103,"type":101},"2021-03-10",{"date":105,"type":89},"2026-12-31",{"name":5,"class":6},2]