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543","robert.gooley@monashhealth.org",{"facility":722,"status":86,"city":723,"state":724,"zip":725,"country":726,"countryCode":727,"cosmosGeoPoint":728,"geoPoint":732,"contacts":733},"Beijing Anzhen Hospital of the Capital University of Medical Sciences","Beijing","Beijing Municipality","100000","China","CN",{"type":93,"coordinates":729},[730,731],116.39723,39.9075,{"lat":731,"lon":730},[734],{"name":735,"role":76,"phone":736,"phoneExt":64,"email":737},"Yong Zeng, MD","010-64456966","office@anzhengcp.com",{"facility":739,"status":86,"city":740,"state":740,"zip":725,"country":726,"countryCode":727,"cosmosGeoPoint":741,"geoPoint":745,"contacts":746},"Fuwai Hospital Chinese Academy of Medical Sciences","Beijin",{"type":93,"coordinates":742},[743,744],111.40836,35.93305,{"lat":744,"lon":743},[747],{"name":748,"role":76,"phone":749,"phoneExt":64,"email":750},"Yongjian Wu, MD","010-88398395","fwjg@fuwai.com",{"facility":752,"status":86,"city":753,"state":753,"zip":754,"country":726,"countryCode":727,"cosmosGeoPoint":755,"geoPoint":759,"contacts":760},"The First Affiliated Hospital, Sun Yat-sen University","Guangzhou","510080",{"type":93,"coordinates":756},[757,758],113.25,23.11667,{"lat":758,"lon":757},[761],{"name":762,"role":76,"phone":763,"phoneExt":64,"email":764},"Yi Li, MD","020-87755766","zsyyyb@mail.sysu.edu.cn",{"facility":766,"status":86,"city":767,"state":768,"zip":769,"country":726,"countryCode":727,"cosmosGeoPoint":770,"geoPoint":774,"contacts":775},"Wuhan Asia Heart Hospital","Wuhan","Hubei","430022",{"type":93,"coordinates":771},[772,773],114.26667,30.58333,{"lat":773,"lon":772},[776],{"name":777,"role":76,"phone":778,"phoneExt":64,"email":779},"Dan Song, MD","18963980171","Songdan8300@163.com",{"facility":781,"status":86,"city":782,"state":64,"zip":783,"country":726,"countryCode":727,"cosmosGeoPoint":784,"geoPoint":788,"contacts":789},"The First Affiliated Hospital of Xi'an Jiaotong University","Xi'an","710061",{"type":93,"coordinates":785},[786,787],108.92861,34.25833,{"lat":787,"lon":786},[790],{"name":791,"role":76,"phone":792,"phoneExt":64,"email":793},"Zuyi Yuan, MD","1 399 122 9101","nguomd@mail.xjtu.edu.cn",{"facility":795,"status":86,"city":796,"state":64,"zip":797,"country":798,"countryCode":799,"cosmosGeoPoint":800,"geoPoint":804,"contacts":805},"Cellitinnen Krankenhaus St. Vinzenz","Cologne","50733","Germany","DE",{"type":93,"coordinates":801},[802,803],6.95,50.93333,{"lat":803,"lon":802},[806],{"name":807,"role":76,"phone":808,"phoneExt":64,"email":809},"Jan-Malte Sinning, MD","+4922177120","jan-malte.sinning@cellitinnen.de",{"facility":811,"status":86,"city":812,"state":64,"zip":813,"country":798,"countryCode":799,"cosmosGeoPoint":814,"geoPoint":818,"contacts":819},"MEDICLIN Herzzentrum Lahr","Lahr","77933",{"type":93,"coordinates":815},[816,817],7.86886,48.34042,{"lat":817,"lon":816},[820],{"name":821,"role":76,"phone":822,"phoneExt":64,"email":823},"Kambis Mashayekhi, MD","004978211330","Kambis.Mashayekhi@mediclin.de",{"facility":825,"status":86,"city":826,"state":64,"zip":827,"country":828,"countryCode":829,"cosmosGeoPoint":830,"geoPoint":834,"contacts":835},"Mater Private Hospital Cork","Cork","T12 K199","Ireland","IE",{"type":93,"coordinates":831},[832,833],-8.47061,51.89797,{"lat":833,"lon":832},[836],{"name":837,"role":76,"phone":838,"phoneExt":64,"email":839},"Paul Hill, MD","0216013200","Paul.Hill@materprivate.ie",{"facility":841,"status":86,"city":842,"state":64,"zip":843,"country":828,"countryCode":829,"cosmosGeoPoint":844,"geoPoint":848,"contacts":849},"Mater Private Hospital","Dublin","D07 RD8P",{"type":93,"coordinates":845},[846,847],-6.24889,53.33306,{"lat":847,"lon":846},[850],{"name":851,"role":76,"phone":852,"phoneExt":64,"email":853},"Robert Byrne, MD","+353(0)12481843","Robert.byrne@materprivate.ie",{"facility":855,"status":86,"city":856,"state":64,"zip":857,"country":828,"countryCode":829,"cosmosGeoPoint":858,"geoPoint":862,"contacts":863},"Galway University Hospital","Galway","H91 YR71",{"type":93,"coordinates":859},[860,861],-9.05095,53.27245,{"lat":861,"lon":860},[864],{"name":865,"role":76,"phone":866,"phoneExt":64,"email":867},"Faisal Sharif, MD","0861455568","Faisal.sharif@universityofgalway.ie",{"facility":869,"status":86,"city":870,"state":871,"zip":872,"country":873,"countryCode":874,"cosmosGeoPoint":875,"geoPoint":879,"contacts":880},"Medical Corporation Sapporo Heart Center Sapporo Cardiovascular Clinic","Sapporo","Hokkaido","007-0849","Japan","JP",{"type":93,"coordinates":876},[877,878],141.35,43.06667,{"lat":878,"lon":877},[881],{"name":882,"role":76,"phone":883,"phoneExt":64,"email":884},"Shoichi Kuramitsu, MD","+81-011-784-784-7","kuramitsu@heart-kizuna.com",{"facility":886,"status":86,"city":887,"state":64,"zip":888,"country":873,"countryCode":874,"cosmosGeoPoint":889,"geoPoint":893,"contacts":894},"Chikamori Hospital","Kochi","780-8522",{"type":93,"coordinates":890},[891,892],133.53333,33.55,{"lat":892,"lon":891},[895],{"name":896,"role":76,"phone":897,"phoneExt":64,"email":898},"Ryuichiro Imai, MD","+81-88-822-5231","ryuichirou-imai@hkg.odn.ne.jp",{"facility":900,"status":86,"city":901,"state":64,"zip":902,"country":903,"countryCode":904,"cosmosGeoPoint":905,"geoPoint":909,"contacts":910},"Auckland City Hospital","Auckland","1010","New Zealand","NZ",{"type":93,"coordinates":906},[907,908],174.76349,-36.84853,{"lat":908,"lon":907},[911],{"name":912,"role":76,"phone":913,"phoneExt":64,"email":914},"Jithendra Somaratne, MD","6493074949","jithendras@adhb.govt.nz",{"facility":916,"status":86,"city":917,"state":64,"zip":918,"country":919,"countryCode":64,"cosmosGeoPoint":920,"geoPoint":924,"contacts":925},"Samsung Medical Center","Seoul","06351","South Korea",{"type":93,"coordinates":921},[922,923],126.9784,37.566,{"lat":923,"lon":922},[926],{"name":927,"role":76,"phone":928,"phoneExt":64,"email":929},"Joo Myung Lee, MD","+82-2-3410-2575","drone80@hanmail.net",{"facility":931,"status":86,"city":932,"state":64,"zip":933,"country":934,"countryCode":935,"cosmosGeoPoint":936,"geoPoint":940,"contacts":941},"Hospital Universitario de La Princesa","Madrid","28006","Spain","ES",{"type":93,"coordinates":937},[938,939],-3.70256,40.4165,{"lat":939,"lon":938},[942],{"name":943,"role":76,"phone":944,"phoneExt":64,"email":945},"Fernando Alfonso, MD","+34913303283","falf@hotmail.com",{"facility":947,"status":86,"city":948,"state":64,"zip":949,"country":934,"countryCode":935,"cosmosGeoPoint":950,"geoPoint":954,"contacts":955},"Hospital Universitario y Politécnico La Fe","Valencia","46026",{"type":93,"coordinates":951},[952,953],-0.37966,39.47391,{"lat":953,"lon":952},[956],{"name":957,"role":76,"phone":958,"phoneExt":64,"email":959},"Jorge Sanz, MD","+34961244000","sjorge4@gmx.com",{"facility":961,"status":86,"city":962,"state":64,"zip":963,"country":934,"countryCode":935,"cosmosGeoPoint":964,"geoPoint":968,"contacts":969},"Clínico de Valladolid","Valladolid","47012",{"type":93,"coordinates":965},[966,967],-4.72353,41.65541,{"lat":967,"lon":966},[970],{"name":971,"role":76,"phone":972,"phoneExt":64,"email":973},"Ignacio Amat-Santos, MD","+34657923040","ijamat@gmail.com",{"type":975,"investigatorFullName":64,"investigatorTitle":64,"investigatorAffiliation":64,"oldNameTitle":64,"oldOrganization":64},"SPONSOR","100589831","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-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":986,"type":987},1616,"ESTIMATED","INTERVENTIONAL",[990],"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.",[993,994],"Coronary Arterial Disease (CAD)","de Novo Lesions in Native Coronary Arteries",[996,997,998],"Drug Coated Balloon","de novo","97279374","2026-07-01",{"date":1001,"type":1002},"2026-07-02","ACTUAL",{"date":1004,"type":1002},"2025-08-21",{"date":1006,"type":987},"2032-03",{"name":5,"class":6},62]