[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627237":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":35,"responsibleParty":55,"collaborators":20,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":60,"sex":66,"minAge":67,"maxAge":20,"enrollmentInfo":68,"targetDuration":20,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":79,"overallStatus":38,"whyStopped":20,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"China National Center for Cardiovascular Diseases","OTHER_GOV",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"IVUS-FFR Online Assessment","EXPERIMENTAL","Intervention Protocol\n\nParticipants receive a real-time functional coronary evaluation using the integrated IVUS-FFR system during diagnostic angiography. The procedure consists of three sequential phases:\n\nIVUS Image Acquisition A clinically approved IVUS catheter (40MHz frequency) is advanced to the target coronary segment Standardized automated pullback (0.5 mm\u002Fsec) captures cross-sectional vessel images Minimum imaging length: 30mm proximal-to-distal to stenosis Real-Time Computational Analysis DICOM data transfer to IVUS-FFR processing platform\n\nAI-driven segmentation of:\n\nLumen boundaries External elastic lamina (EEL) Plaque morphology\n\nHemodynamic simulation using:\n\nAdaptive blood flow models based on Murray's law Branching-specific flow distribution algorithms Processing time: ≤90 seconds Diagnostic Output Delivery Primary metric: Computed IVUS-FFR value (scale 0-1) Clinical threshold: IVUS-FFR ≤0.80 = hemodynamically significant stenosis Quality control: Auto",[13],"Diagnostic Test: Ultrasound-Derived Fractional Flow Reserve Computational System",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DIAGNOSTIC_TEST","Ultrasound-Derived Fractional Flow Reserve Computational System","1. Core Technological Innovation\n\n   This diagnostic system revolutionizes coronary stenosis assessment by integrating intravascular ultrasound (IVUS) imaging with real-time computational physiology . Its proprietary technology features:\n\n   AI-driven vessel segmentation : Deep neural networks automatically delineate lumen boundaries and external elastic lamina from IVUS images, enabling millimeter-level precision in 3D coronary reconstruction.\n\n   Dynamic hemodynamic modeling : Adaptive algorithms apply Murray's law to calculate branch-specific blood flow distribution, accounting for plaque composition (calcified\u002Ffibrous\u002Flipidic) and vessel tapering.\n2. Procedural Implementation\n\nThe intervention seamlessly integrates into standard coronary angiography workflows:\n\nImage acquisition : A 40MHz IVUS catheter performs automated pullback (0.5 mm\u002Fsec) across the target stenosis and adjacent segments.\n\nReal-time processing : DICOM data transfers to an embedded GPU server, initiat",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Kefei Dou, MD","Chinese Academy of Medical Sciences and Peking Union Medical College","STUDY_CHAIR",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Kefei Dou, Principal Investigator","CONTACT","15980609858","drdoukefei@126.com",{"name":33,"role":29,"phone":30,"phoneExt":20,"email":34},"Zhihao Zheng, MD","fwzh97@126.com",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Fuwai hospital","RECRUITING","Beijing","Beijing Municipality","100037","China","CN",{"type":45,"coordinates":46},"Point",[47,48],116.39723,39.9075,{"lat":48,"lon":47},[51,52,53],{"name":33,"role":29,"phone":30,"phoneExt":20,"email":34},{"name":33,"role":29,"phone":20,"phoneExt":20,"email":34},{"name":33,"role":54,"phone":20,"phoneExt":20,"email":20},"SUB_INVESTIGATOR",{"type":56,"investigatorFullName":23,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Kefei Dou, MD, Professor, China National Center for Cardiovascular Diseases","100627237","ivus-ffr-accuracy-for-coronary-stenosis-100627237",false,"NCT07446023","IVUS-FFR Accuracy for Coronary Stenosis","Diagnostic Accuracy of Intravascular Ultrasound-Derived Fractional Flow Reserve for Online Assessment of Functionally Significant Coronary Stenosis: A Multicenter Prospective Study","IVUS-FFR","Inclusion Criteria General Requirements\n\n* 18 years of age Diagnosed with stable\u002Funstable angina or post-acute phase myocardial infarction (\\>72 hours after onset) Able to comprehend study design and provide written informed consent Angiographic \\& IVUS-Specific Requirements\n* 1 epicardial coronary artery with 30%-90% visual diameter stenosis Reference vessel diameter ≥2.0 mm at target stenosis site Exclusion Criteria General Exclusions Contraindications to invasive procedures\u002FFFR per operator judgment Acute myocardial infarction within 72 hours Cardiogenic shock or severe heart failure (NYHA class ≥III or LVEF \\\u003C30%) Severe renal dysfunction (Creatinine \\>150 μmol\u002FL or eGFR \\\u003C45 mL\u002Fmin\u002F1.73m²) Allergy to iodinated contrast media or adenosine Pregnancy\u002Flactation Life expectancy \\\u003C1 year Concurrent participation in other interventional trials Angiographic \\& IVUS-Specific Exclusions Myocardial bridging at target lesion Severely calcified or tortuous vessels precluding safe IVUS Isolated \\>90% stenosis with TIMI flow grade \\\u003C3 in major epicardial artery Other conditions deemed unsuitable for IVUS\u002FFFR by investigators","ALL","18 Years",{"count":69,"type":70},292,"ESTIMATED","INTERVENTIONAL",[73],"NA","IVUS-FFR Online Accuracy for Coronary Stenosis What is this study testing? This study is testing a new technology called IVUS-FFR , which uses ultrasound imaging inside heart arteries (IVUS) to quickly measure whether a narrowed artery ( coronary stenosis ) is reducing blood flow. Unlike the current standard test (FFR), this new method doesn't require extra wires or medication to work.\n\nWhy is this important?\n\nMany patients with heart artery narrowing need tests to decide if a stent is necessary.\n\nCurrent FFR tests involve inserting a pressure wire and giving medication (like adenosine) that can cause discomfort.\n\nIVUS-FFR could provide equally accurate results faster, cheaper, and more comfortably .\n\nWhat happens in the study?\n\nIf you join:\n\nStandard heart artery imaging (angiogram) will be performed. An ultrasound probe (IVUS) will be moved through the artery to create detailed images.\n\nThe new IVUS-FFR software will analyze these images immediately to estimate blood flow.\n\nFor comparison, a standard FFR test (with pressure wire and medication) will also be done.\n\nAll steps use existing approved devices and take \\\u003C10 extra minutes. Who can participate?\n\nAdults (≥18 years) with:\n\nSuspected or known heart artery disease At least one artery narrowing (30%-90% blocked) Excluded: Recent heart attack (\\\u003C72 hrs), severe kidney\u002Fheart failure, or pregnancy.\n\nWhat are the risks and benefits?\n\nRisks: Same as routine heart catheterization (bleeding, infection, artery injury). The IVUS and FFR steps add minimal extra risk.\n\nBenefits: No direct benefit, but results may improve future care by reducing need for invasive tests.\n\nStudy goal:\n\nTo validate if IVUS-FFR is as accurate as the current FFR standard in 292 patients across multiple hospitals in China.\n\nWho is running the study? Led by heart specialists at Fuwai Hospital (Beijing) - China's top cardiovascular center - with ethics committee oversight.",[76,77,78],"Percutaneous Coronary Intervention","Intravenous Ultrasound","Coronary Physiology",[76,77,78,80,64,81],"Fractional Flow Reserve","Diagnostic Accuracy","2026-02-25",{"date":84,"type":85},"2026-03-03","ACTUAL",{"date":87,"type":85},"2025-07-01",{"date":89,"type":70},"2026-12-31",{"name":5,"class":6},1]