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Sciences","Beijin",{"type":92,"coordinates":739},[740,741],111.40836,35.93305,{"lat":741,"lon":740},[744],{"name":745,"role":76,"phone":746,"phoneExt":64,"email":747},"Yongjian Wu, MD","010-88398395","fwjg@fuwai.com",{"facility":749,"status":86,"city":750,"state":750,"zip":751,"country":724,"cosmosGeoPoint":752,"geoPoint":756,"contacts":757},"The First Affiliated Hospital, Sun Yat-sen University","Guangzhou","510080",{"type":92,"coordinates":753},[754,755],113.25,23.11667,{"lat":755,"lon":754},[758],{"name":759,"role":76,"phone":760,"phoneExt":64,"email":761},"Yi Li, MD","020-87755766","zsyyyb@mail.sysu.edu.cn",{"facility":763,"status":86,"city":764,"state":765,"zip":766,"country":724,"cosmosGeoPoint":767,"geoPoint":771,"contacts":772},"Wuhan Asia Heart Hospital","Wuhan","Hubei","430022",{"type":92,"coordinates":768},[769,770],114.26667,30.58333,{"lat":770,"lon":769},[773],{"name":774,"role":76,"phone":775,"phoneExt":64,"email":776},"Dan Song, MD","18963980171","Songdan8300@163.com",{"facility":778,"status":86,"city":779,"state":64,"zip":780,"country":724,"cosmosGeoPoint":781,"geoPoint":785,"contacts":786},"The First Affiliated Hospital of Xi'an Jiaotong University","Xi'an","710061",{"type":92,"coordinates":782},[783,784],108.92861,34.25833,{"lat":784,"lon":783},[787],{"name":788,"role":76,"phone":789,"phoneExt":64,"email":790},"Zuyi Yuan, MD","1 399 122 9101","nguomd@mail.xjtu.edu.cn",{"facility":792,"status":86,"city":793,"state":64,"zip":794,"country":795,"cosmosGeoPoint":796,"geoPoint":800,"contacts":801},"Cellitinnen Krankenhaus St. Vinzenz","Cologne","50733","Germany",{"type":92,"coordinates":797},[798,799],6.95,50.93333,{"lat":799,"lon":798},[802],{"name":803,"role":76,"phone":804,"phoneExt":64,"email":805},"Jan-Malte Sinning, MD","+4922177120","jan-malte.sinning@cellitinnen.de",{"facility":807,"status":86,"city":808,"state":64,"zip":809,"country":795,"cosmosGeoPoint":810,"geoPoint":814,"contacts":815},"MEDICLIN Herzzentrum Lahr","Lahr","77933",{"type":92,"coordinates":811},[812,813],7.86886,48.34042,{"lat":813,"lon":812},[816],{"name":817,"role":76,"phone":818,"phoneExt":64,"email":819},"Kambis Mashayekhi, MD","004978211330","Kambis.Mashayekhi@mediclin.de",{"facility":821,"status":86,"city":822,"state":64,"zip":823,"country":824,"cosmosGeoPoint":825,"geoPoint":829,"contacts":830},"Mater Private Hospital Cork","Cork","T12 K199","Ireland",{"type":92,"coordinates":826},[827,828],-8.47061,51.89797,{"lat":828,"lon":827},[831],{"name":832,"role":76,"phone":833,"phoneExt":64,"email":834},"Paul Hill, MD","0216013200","Paul.Hill@materprivate.ie",{"facility":836,"status":86,"city":837,"state":64,"zip":838,"country":824,"cosmosGeoPoint":839,"geoPoint":843,"contacts":844},"Mater Private Hospital","Dublin","D07 RD8P",{"type":92,"coordinates":840},[841,842],-6.24889,53.33306,{"lat":842,"lon":841},[845],{"name":846,"role":76,"phone":847,"phoneExt":64,"email":848},"Robert Byrne, MD","+353(0)12481843","Robert.byrne@materprivate.ie",{"facility":850,"status":86,"city":851,"state":64,"zip":852,"country":824,"cosmosGeoPoint":853,"geoPoint":857,"contacts":858},"Galway University Hospital","Galway","H91 YR71",{"type":92,"coordinates":854},[855,856],-9.05095,53.27245,{"lat":856,"lon":855},[859],{"name":860,"role":76,"phone":861,"phoneExt":64,"email":862},"Faisal Sharif, MD","0861455568","Faisal.sharif@universityofgalway.ie",{"facility":864,"status":86,"city":865,"state":866,"zip":867,"country":868,"cosmosGeoPoint":869,"geoPoint":873,"contacts":874},"Medical Corporation Sapporo Heart Center Sapporo Cardiovascular Clinic","Sapporo","Hokkaido","007-0849","Japan",{"type":92,"coordinates":870},[871,872],141.35,43.06667,{"lat":872,"lon":871},[875],{"name":876,"role":76,"phone":877,"phoneExt":64,"email":878},"Shoichi Kuramitsu, MD","+81-011-784-784-7","kuramitsu@heart-kizuna.com",{"facility":880,"status":86,"city":881,"state":64,"zip":882,"country":868,"cosmosGeoPoint":883,"geoPoint":887,"contacts":888},"Chikamori Hospital","Kochi","780-8522",{"type":92,"coordinates":884},[885,886],133.53333,33.55,{"lat":886,"lon":885},[889],{"name":890,"role":76,"phone":891,"phoneExt":64,"email":892},"Ryuichiro Imai, MD","+81-88-822-5231","ryuichirou-imai@hkg.odn.ne.jp",{"facility":894,"status":86,"city":895,"state":64,"zip":896,"country":897,"cosmosGeoPoint":898,"geoPoint":902,"contacts":903},"Auckland City Hospital","Auckland","1010","New Zealand",{"type":92,"coordinates":899},[900,901],174.76349,-36.84853,{"lat":901,"lon":900},[904],{"name":905,"role":76,"phone":906,"phoneExt":64,"email":907},"Jithendra Somaratne, MD","6493074949","jithendras@adhb.govt.nz",{"facility":909,"status":86,"city":910,"state":64,"zip":911,"country":912,"cosmosGeoPoint":913,"geoPoint":917,"contacts":918},"Samsung Medical Center","Seoul","06351","South Korea",{"type":92,"coordinates":914},[915,916],126.9784,37.566,{"lat":916,"lon":915},[919],{"name":920,"role":76,"phone":921,"phoneExt":64,"email":922},"Joo Myung Lee, MD","+82-2-3410-2575","drone80@hanmail.net",{"facility":924,"status":86,"city":925,"state":64,"zip":926,"country":927,"cosmosGeoPoint":928,"geoPoint":932,"contacts":933},"Hospital Universitario de La Princesa","Madrid","28006","Spain",{"type":92,"coordinates":929},[930,931],-3.70256,40.4165,{"lat":931,"lon":930},[934],{"name":935,"role":76,"phone":936,"phoneExt":64,"email":937},"Fernando Alfonso, MD","+34913303283","falf@hotmail.com",{"facility":939,"status":86,"city":940,"state":64,"zip":941,"country":927,"cosmosGeoPoint":942,"geoPoint":946,"contacts":947},"Hospital Universitario y Politécnico La Fe","Valencia","46026",{"type":92,"coordinates":943},[944,945],-0.37966,39.47391,{"lat":945,"lon":944},[948],{"name":949,"role":76,"phone":950,"phoneExt":64,"email":951},"Jorge Sanz, MD","+34961244000","sjorge4@gmx.com",{"facility":953,"status":86,"city":954,"state":64,"zip":955,"country":927,"cosmosGeoPoint":956,"geoPoint":960,"contacts":961},"Clínico de Valladolid","Valladolid","47012",{"type":92,"coordinates":957},[958,959],-4.72353,41.65541,{"lat":959,"lon":958},[962],{"name":963,"role":76,"phone":964,"phoneExt":64,"email":965},"Ignacio Amat-Santos, MD","+34657923040","ijamat@gmail.com",{"type":967,"investigatorFullName":64,"investigatorTitle":64,"investigatorAffiliation":64,"oldNameTitle":64,"oldOrganization":64},"SPONSOR","100589831",false,"NCT06959524","AGENT DCB STANCE: Safety and Effectiveness Study of AGENT Drug-Coated Balloon Compared to Standard of Care Percutaneous Coronary Intervention (PCI) Treatment for de Novo Coronary Lesions","AGENT DCB STANCE: AGENT Drug-Coated Balloon for STent AvoidANCE in PCI for De Novo Coronary Artery Disease","Clinical Inclusion Criteria:\n\n* Subject must be at least 18 years of age.\n* Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed.\n* Subject is eligible for percutaneous coronary intervention (PCI).\n* Subject is willing to comply with all protocol-required follow-up evaluation.\n* Women of child-bearing potential must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure.\n\nAngiographic Inclusion Criteria:\n\n* Target lesion is a de novo lesion located in a native coronary artery\n* Target lesion must have visually estimated stenosis \\> 50% and \\\u003C 100% in symptomatic subjects (\\>70% and \\\u003C100% in asymptomatic subjects) prior to lesion pre-dilation.\n* Target lesion must be successfully pre-dilated.\n* If a non-target lesion is treated, it must be treated first and must be deemed a success.\n\nClinical Exclusion Criteria:\n\n* Subject has other serious medical illness (e.g. cancer, congestive heart failure) that may reduce life expectancy to less than 12 months.\n* Subject has current problems with substance abuse (e.g. alcohol, cocaine, heroin, etc.).\n* Subject has planned procedure that may cause non-compliance with the protocol or confound data interpretation.\n* Subject is participating in another investigational drug or device clinical study that has not reached its primary endpoint.\n* Subject intends to participate in another investigational drug or device clinical study within 12 months after the index procedure.\n* Subject is a woman who is pregnant or nursing. A pregnancy test must be performed within 7 days prior to the index procedure, except for women who definitely do not have child-bearing potential.\n* Subject has left ventricular ejection fraction known to be \\\u003C 30%.\n* Subject had PCI or other coronary interventions within the last 30 days.\n* Subject has planned PCI or CABG after the index procedure.\n* Subject had STEMI or QWMI \\\u003C72h prior to the index procedure.\n* Subject presents with NSTEMI and rising biomarkers, or ongoing chest pain or is hemodynamically unstable.\n* Subject has cardiogenic shock (SBP \\\u003C 80 mmHg requiring inotropes, IABP or fluid support).\n* Subject has history (within 6 months prior to the index procedure) of New York Heart Association (NYHA) class III or IV heart failure.\n* Subject is considered not able to tolerate at least 30 seconds of coronary occlusion of the target lesion.\n* Subject has known allergy to paclitaxel or other components of the used medical devices.\n* Subject has known hypersensitivity or contraindication to contrast dye that in the opinion of the investigator cannot be adequately pre-medicated.\n* Subject has intolerance to antiplatelet drugs, anticoagulants required for procedure.\n* Subject has platelet count \\\u003C 100k\u002Fmm3 (risk of bleeding) or \\> 700k\u002Fmm3.\n* Subject with renal insufficiency (creatinine ≥2.0 mg\u002Fdl) or failure (dialysis dependent).\n\nAngiographic Exclusion Criteria:\n\n* In-stent restenosis.\n* Target lesion is located within a saphenous vein or arterial graft.\n* Target lesion is a total occlusion or has evidence of thrombus present in the target vessel.\n* Target lesion is severely calcified by angiography or has \\> 270° calcium arc on intravascular imaging or requires atherectomy.\n* Subject has unprotected left main coronary artery disease (\\>50% diameter stenosis) or three-vessel coronary disease requiring revascularization of all 3 vessels.\n* Subject with planned treatment of lesion involving aortic ostial location.","ALL","18 Years",{"count":977,"type":978},1616,"ESTIMATED","INTERVENTIONAL",[981],"NA","AGENT DCB STANCE is a prospective, multicenter, open-label, 1:1 randomized controlled study designed to assess the safety and effectiveness of a treatment strategy with the AGENT Drug-Coated Balloon compared to standard of care percutaneous coronary intervention (PCI) treatment with drug eluting stent (DES) and\u002For balloon angioplasty in patients with de novo coronary lesions.\n\nSubjects must have a de novo target lesion located in a native coronary artery.",[984,985],"Coronary Arterial Disease (CAD)","de Novo Lesions in Native Coronary Arteries",[987,988,989],"Drug Coated Balloon","de novo","97279374","2026-07-01",{"date":992,"type":993},"2026-07-02","ACTUAL",{"date":995,"type":993},"2025-08-21",{"date":997,"type":978},"2032-03",{"name":5,"class":6},62]