[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100409491":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":10,"locations":25,"responsibleParty":37,"collaborators":10,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":43,"acronym":10,"eligibilityCriteria":44,"healthyVolunteers":41,"sex":45,"minAge":46,"maxAge":47,"enrollmentInfo":48,"targetDuration":51,"studyType":52,"phases":10,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":62,"whyStopped":10,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":69,"locationsCount":70},{"fullName":5,"class":6},"IHF GmbH - Institut für Herzinfarktforschung","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"All Comer Patients",null,"All-comer patients (≥80 years) affected by acute coronary syn-drome (NSTE-ACS), stabile angina, or silent angina, who qualify for percutaneous coronary intervention (PCI) according to ESC-treatment guidelines and physicians' clinical routine estimation.",[13],"Device: The SUPRAFLEX CRUZ™ Sirolimus eluting coronary stent system",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","The SUPRAFLEX CRUZ™ Sirolimus eluting coronary stent system","Investigational device: SUPRAFLEX CRUZ™ Sirolimus eluting Coronary Stent System The SUPRAFLEX CRUZ™ Sirolimus eluting coronary stent system consists of a balloon ex-pandable Sirolimus eluting stent, premounted on a stent delivery system. The active pharmaceutical ingredient in the SUPRAFLEX CRUZ™ Sirolimus eluting coronary stent is Sirolimus (also known as Rapamycin).\n\nThe SUPRAFLEX CRUZ™ Sirolimus eluting coronary stent system is indicated for improving coronary luminal diameter in patients with symptomatic Ischemic heart disease due to discrete de-novo stenotic lesions and in-stent restenotic lesions in native coronary arter-ies with a reference vessel diameter of 2.00 mm to 4.50 mm.",[9],[21],{"name":22,"affiliation":23,"role":24},"David M Leistner, Prof","Charite University, Berlin, Germany","PRINCIPAL_INVESTIGATOR",[26],{"facility":27,"status":10,"city":28,"state":10,"zip":10,"country":29,"countryCode":30,"cosmosGeoPoint":31,"geoPoint":36,"contacts":10},"Charité Berlin","Berlin","Germany","DE",{"type":32,"coordinates":33},"Point",[34,35],13.41053,52.52437,{"lat":35,"lon":34},{"type":38,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100409491","post-market-registry-to-evaluate-the-safety-and-efficacy-of-the-the-supraflex-cruz-sirolimus-eluting-coronary-stent-system-in-the-treatment-of-an-octo--and-nonagenerian-all-comer-patient-cohort-with-coronary-artery-disease---the-cruz-senior-study-100409491",false,"NCT04612179","Post-Market Registry to Evaluate the Safety and Efficacy of the The SUPRAFLEX CRUZ™ Sirolimus Eluting Coronary Stent System in the Treatment of an Octo- and Nonagenerian All-Comer Patient Cohort With Coronary Artery Disease - the Cruz Senior Study","Inclusion Criteria:\n\n1. Written consent received from the patient or a legal repre-sentative after the information has been provided.\n2. ≥ 80 years of age.\n3. De-novo or re-stenotic significant stenosis in at least one cor-onary vessel.\n4. Patients with NSTE-ACS, unstable angina, stable angina, silent ischemia (no limitation of the number of treated lesions and vessels: planned staged procedures are allowed within 3 months using Supraflex Cruz only).\n5. Target lesion suitable for PCI with SUPRAFLEX CRUZ™ Siroli-mus eluting coronary stent system with diameter between 2.0 and 4.5 mm\n6. Total lesion length should be from 6-120 mm\n\nExclusion Criteria:\n\n1. Patients with ST-elevation myocardial infarction (STE-ACS)\n2. Hemodynamic instability or cardiogenic shock\n3. Known hypersensitivity or contraindication to any component of the study stent or the eluting drug, to media contrast, to dual antiplatelet therapy (DAPT) medication required by cur-rent practice\n4. Any co-morbid condition with life expectancy \\\u003C 1 year or that may result in protocol non-compliance\n5. Patients who are participating in another drug or device inves-tigational study, which has not reached its primary endpoint\n6. Patients under judicial protection, tutorship or curatorship","ALL","80 Years","99 Years",{"count":49,"type":50},2017,"ACTUAL","12 Months","OBSERVATIONAL","Prospective, multi-centre, open-label, single-armed, non-interventional observational clinical investigation designed to enrol 2000 octo- and nonagenerian all-comer patients with coro-nary artery disease in up to 37 sites in Germany, Switzerland and Austria. Patients underwent PCI using at least one Supraflex Cruz Sirolimus Eluting stent as per current practice and will be followed up for 12 months.",[55],"Coronary Disease",[57,58,59,60,61],"CAD","PCI","Cruz Stent","CCS","NSTE-ACS","COMPLETED","2025-06-12",{"date":65,"type":50},"2025-06-17",{"date":67,"type":50},"2021-06-23",{"date":63,"type":50},{"name":5,"class":6},1]