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Alkhalil",{"facility":242,"status":35,"city":243,"state":15,"zip":15,"country":220,"countryCode":221,"cosmosGeoPoint":244,"geoPoint":248,"contacts":249},"University Hospitals Southampton","Southampton",{"type":40,"coordinates":245},[246,247],-1.40428,50.90395,{"lat":247,"lon":246},[250],{"name":251,"role":48,"phone":15,"phoneExt":15,"email":15},"Nick Curzen",{"type":48,"investigatorFullName":253,"investigatorTitle":254,"investigatorAffiliation":5,"oldNameTitle":15,"oldOrganization":15},"Patrick Serruys","Professor of Interventional Cardiology & Innovation at the National University of Ireland, Galway, Ireland","100433366","the-pioneer-iv-study-is-comparing-clinical-outcomes-between-angiography-derived-physiology-guidance-to-usual-care-in-an-all-comers-pci-population-with-unrestrictive-use-of-the-ht-supreme-sirolimus-eluting-stent-100433366",false,"NCT04923191","The PIONEER-IV Study is Comparing Clinical Outcomes Between Angiography-derived Physiology Guidance to Usual Care in an 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provisions and has provided written informed consent as approved by the Ethical Committee and is willing to comply with all protocol-required (follow-up) evaluations.\n\nExclusion Criteria:\n\n1. Patient is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential according to local practice);\n2. Known intolerance to cobalt chromium, and medications such as sirolimus, aspirin, heparin, bivalirudin or P2Y12 inhibitors;\n3. Planned major elective surgery requiring discontinuation of (dual)anti platelet therapy (DAPT) within 12 months of procedure;\n4. Concurrent medical condition with a life expectancy of less than 3 years;\n5. Currently participating in another trial and not yet at its primary endpoint;\n6. Active pathological bleeding;\n7. History of intracranial haemorrhage.","ALL","18 Years",{"count":266,"type":267},2540,"ESTIMATED","INTERVENTIONAL",[270],"NA","PIONEER-IV is a prospective, single-blind (patient), randomized, 1:1, controlled, multi-center study comparing clinical outcomes between angiography-derived physiology guidance to LRDP and usual care in an all-comers patient population (including patients with high bleeding risk, HBR) undergoing PCI with unrestrictive use of the HT Supreme sirolimus-eluting stent. Patients will be randomized to either angio-based physiology guidance angio-FFR (Quantitative Flow Ratio and coronary angiography-derived FFR, caFFR) or local routine diagnostic procedure (LRDP) and usual care. Patients will be treated with 1-year P2Y12 inhibitor monotherapy after 1-month of dual-antiplatelet therapy in approximately 2540 (2\\*1270) patients. All patients (both cohorts) must receive dual anti-platelet therapy, being aspirin (ASA) and ticagrelor for 1 month, followed by 11 months of ticagrelor only (i.e. monotherapy). At 1 year, ticagrelor monotherapy is replaced by aspirin monotherapy or left to the discretion of the operator.",[273],"Coronary Artery Disease",[275,276,277,278,279,280,281,282],"coronary artery disease","ischemia","quantitative flow ratio (QFR)","P2Y12 monotherapy","drug-eluting stent","physiology guidance","angio-FFR","Coronary Angiography-derived FFR (caFFR)","2023-10-26",{"date":285,"type":286},"2023-10-30","ACTUAL",{"date":288,"type":286},"2021-11-12",{"date":290,"type":267},"2029-01",{"name":5,"class":6},19]