[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100564178":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":29,"locations":10,"responsibleParty":37,"collaborators":39,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":10,"eligibilityCriteria":50,"healthyVolunteers":46,"sex":51,"minAge":52,"maxAge":10,"enrollmentInfo":53,"targetDuration":56,"studyType":57,"phases":10,"briefSummary":58,"conditions":59,"keywords":63,"overallStatus":68,"whyStopped":10,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":10},{"fullName":5,"class":6},"ECRI bv","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"IVUS-guided PCI in patients traditionally underrepresented in clinical trials",null,"Patients undergoing IVUS-guided PCI for complex coronary artery disease who self-identify within a census-defined minority in the United States",[13],"Device: IVUS",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","IVUS","Intravascular Ultrasound",[9],[21,25],{"name":22,"affiliation":23,"role":24},"Ernest Spitzer, MD","European Cardiovascular Research Institute","STUDY_DIRECTOR",{"name":26,"affiliation":27,"role":28},"David E Kandzari, MD","Piedmont Heart Institute","PRINCIPAL_INVESTIGATOR",[30,35],{"name":31,"role":32,"phone":33,"phoneExt":10,"email":34},"Chantal Bakker","CONTACT","31+102062828","CBakker@cardialysis.nl",{"name":22,"role":32,"phone":33,"phoneExt":10,"email":36},"e.spitzer@ecri-trials.com",{"type":38,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[40,42],{"name":41,"class":6},"Boston Scientific Corporation",{"name":43,"class":6},"Cardialysis B.V.","100564178","ivus-chip-upp-registry-100564178",false,"NCT06625801","IVUS CHIP UPP Registry","Intravascular Ultrasound Guidance for Complex High-risk Indicated Procedures in Underrepresented Patient Populations Registry","Inclusion Criteria:\n\n1. The patient must be ≥18 years of age and self-identify within a US census-defined minority\n2. Patients with an indication for PCI of at least one lesion satisfying any of the following criteria:\n\n   1. Angiographic heavy calcification\n   2. Ostial lesions\n   3. True bifurcation lesions involving side-branches \\>2.5mm\n   4. Left main lesions\n   5. Chronic total occlusion\n   6. In-stent restenosis\n   7. Long-lesions (estimated stent length \\> 28mm) OR Patient with an indication for PCI for any lesion and in need for elective mechanical circulatory support assisted PCI\n3. Presenting with silent ischemia, stable angina, unstable angina or non-ST-elevation acute coronary syndrome (NSTE-ACS)\n4. All lesions must be suitable for treatment with FDA-approved contemporary generation drug eluting stents or drug-coated balloons\n5. The patient is willing and able to cooperate with registry procedures and follow-up until registry completion\n6. Subject is able to confirm understanding of risks, benefits and treatment alternatives and he\u002Fshe (or an authorized legal representative) provides informed consent prior to any protocol-related procedure, as approved by the appropriate IRB\n\nExclusion Criteria:\n\n1. ST-elevation myocardial infarction or cardiogenic shock within prior 7 days\n2. Known untreated severe valvular heart disease\n3. Contraindication on the use of IVUS (i.e. extreme vessel tortuosity)\n4. Requiring PCI in a diseased aorto-coronary bypass\n5. Known contraindication or hypersensitivity to anticoagulants\n6. Absolute contraindications or allergy that cannot be pre-medicated, to iodinated contrast or to antiplatelet drugs, including both aspirin and P2Y12 inhibitors\n7. Non-cardiac co-morbidities with a life expectancy less than 1 year\n8. A patients that is currently participating in a clinical trial that has not yet reached its primary endpoint cannot be included in this registry. A patient may only be enrolled in this registry once.","ALL","18 Years",{"count":54,"type":55},1010,"ESTIMATED","24 Months","OBSERVATIONAL","The IVUS CHIP UPP Registry is a prospective, observational, multicenter, single-arm registry. A total of 1010 patients with complex coronary lesions will be enrolled in up to 2 years, with at least 500 men and women. All patients will be treated with IVUS-guided PCI.",[60,61,62],"Coronary Artery Disease","Coronary Artery Disease Risk High","Complex Coronary Artery Disease",[64,65,66,67],"PCI","intravascular ultrasound","CHIP","ivus-guidance","NOT_YET_RECRUITING","2025-08-25",{"date":71,"type":72},"2025-09-02","ACTUAL",{"date":74,"type":55},"2025-09",{"date":76,"type":55},"2029-03",{"name":5,"class":6}]