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Hospital","Clayton","Victoria","3168",{"type":107,"coordinates":726},[727,728],145.11667,-37.91667,{"lat":728,"lon":727},[731],{"name":732,"role":90,"phone":733,"phoneExt":13,"email":734},"Robert Gooley, MD","+61 395 944 543","robert.gooley@monashhealth.org",{"facility":736,"status":100,"city":737,"state":738,"zip":739,"country":740,"countryCode":741,"cosmosGeoPoint":742,"geoPoint":746,"contacts":747},"Beijing Anzhen Hospital of the Capital University of Medical Sciences","Beijing","Beijing Municipality","100000","China","CN",{"type":107,"coordinates":743},[744,745],116.39723,39.9075,{"lat":745,"lon":744},[748],{"name":749,"role":90,"phone":750,"phoneExt":13,"email":751},"Yong Zeng, MD","010-64456966","office@anzhengcp.com",{"facility":753,"status":100,"city":754,"state":754,"zip":739,"country":740,"countryCode":741,"cosmosGeoPoint":755,"geoPoint":759,"contacts":760},"Fuwai Hospital Chinese Academy of Medical Sciences","Beijin",{"type":107,"coordinates":756},[757,758],111.40836,35.93305,{"lat":758,"lon":757},[761],{"name":762,"role":90,"phone":763,"phoneExt":13,"email":764},"Yongjian Wu, MD","010-88398395","fwjg@fuwai.com",{"facility":766,"status":100,"city":767,"state":767,"zip":768,"country":740,"countryCode":741,"cosmosGeoPoint":769,"geoPoint":773,"contacts":774},"The First Affiliated Hospital, Sun Yat-sen University","Guangzhou","510080",{"type":107,"coordinates":770},[771,772],113.25,23.11667,{"lat":772,"lon":771},[775],{"name":776,"role":90,"phone":777,"phoneExt":13,"email":778},"Yi Li, MD","020-87755766","zsyyyb@mail.sysu.edu.cn",{"facility":780,"status":100,"city":781,"state":782,"zip":783,"country":740,"countryCode":741,"cosmosGeoPoint":784,"geoPoint":788,"contacts":789},"Wuhan Asia Heart Hospital","Wuhan","Hubei","430022",{"type":107,"coordinates":785},[786,787],114.26667,30.58333,{"lat":787,"lon":786},[790],{"name":791,"role":90,"phone":792,"phoneExt":13,"email":793},"Dan Song, MD","18963980171","Songdan8300@163.com",{"facility":795,"status":100,"city":796,"state":13,"zip":797,"country":740,"countryCode":741,"cosmosGeoPoint":798,"geoPoint":802,"contacts":803},"The First Affiliated Hospital of Xi'an Jiaotong University","Xi'an","710061",{"type":107,"coordinates":799},[800,801],108.92861,34.25833,{"lat":801,"lon":800},[804],{"name":805,"role":90,"phone":806,"phoneExt":13,"email":807},"Zuyi Yuan, MD","1 399 122 9101","nguomd@mail.xjtu.edu.cn",{"facility":809,"status":100,"city":810,"state":13,"zip":811,"country":812,"countryCode":813,"cosmosGeoPoint":814,"geoPoint":818,"contacts":819},"Cellitinnen Krankenhaus St. Vinzenz","Cologne","50733","Germany","DE",{"type":107,"coordinates":815},[816,817],6.95,50.93333,{"lat":817,"lon":816},[820],{"name":821,"role":90,"phone":822,"phoneExt":13,"email":823},"Jan-Malte Sinning, MD","+4922177120","jan-malte.sinning@cellitinnen.de",{"facility":825,"status":100,"city":826,"state":13,"zip":827,"country":812,"countryCode":813,"cosmosGeoPoint":828,"geoPoint":832,"contacts":833},"MEDICLIN Herzzentrum Lahr","Lahr","77933",{"type":107,"coordinates":829},[830,831],7.86886,48.34042,{"lat":831,"lon":830},[834],{"name":835,"role":90,"phone":836,"phoneExt":13,"email":837},"Kambis Mashayekhi, MD","004978211330","Kambis.Mashayekhi@mediclin.de",{"facility":839,"status":100,"city":840,"state":13,"zip":841,"country":842,"countryCode":843,"cosmosGeoPoint":844,"geoPoint":848,"contacts":849},"Mater Private Hospital Cork","Cork","T12 K199","Ireland","IE",{"type":107,"coordinates":845},[846,847],-8.47061,51.89797,{"lat":847,"lon":846},[850],{"name":851,"role":90,"phone":852,"phoneExt":13,"email":853},"Paul Hill, MD","0216013200","Paul.Hill@materprivate.ie",{"facility":855,"status":100,"city":856,"state":13,"zip":857,"country":842,"countryCode":843,"cosmosGeoPoint":858,"geoPoint":862,"contacts":863},"Mater Private Hospital","Dublin","D07 RD8P",{"type":107,"coordinates":859},[860,861],-6.24889,53.33306,{"lat":861,"lon":860},[864],{"name":865,"role":90,"phone":866,"phoneExt":13,"email":867},"Robert Byrne, MD","+353(0)12481843","Robert.byrne@materprivate.ie",{"facility":869,"status":100,"city":870,"state":13,"zip":871,"country":842,"countryCode":843,"cosmosGeoPoint":872,"geoPoint":876,"contacts":877},"Galway University Hospital","Galway","H91 YR71",{"type":107,"coordinates":873},[874,875],-9.05095,53.27245,{"lat":875,"lon":874},[878],{"name":879,"role":90,"phone":880,"phoneExt":13,"email":881},"Faisal Sharif, MD","0861455568","Faisal.sharif@universityofgalway.ie",{"facility":883,"status":100,"city":884,"state":885,"zip":886,"country":887,"countryCode":888,"cosmosGeoPoint":889,"geoPoint":893,"contacts":894},"Medical Corporation Sapporo Heart Center Sapporo Cardiovascular Clinic","Sapporo","Hokkaido","007-0849","Japan","JP",{"type":107,"coordinates":890},[891,892],141.35,43.06667,{"lat":892,"lon":891},[895],{"name":896,"role":90,"phone":897,"phoneExt":13,"email":898},"Shoichi Kuramitsu, MD","+81-011-784-784-7","kuramitsu@heart-kizuna.com",{"facility":900,"status":100,"city":901,"state":13,"zip":902,"country":887,"countryCode":888,"cosmosGeoPoint":903,"geoPoint":907,"contacts":908},"Chikamori Hospital","Kochi","780-8522",{"type":107,"coordinates":904},[905,906],133.53333,33.55,{"lat":906,"lon":905},[909],{"name":910,"role":90,"phone":911,"phoneExt":13,"email":912},"Ryuichiro Imai, MD","+81-88-822-5231","ryuichirou-imai@hkg.odn.ne.jp",{"facility":914,"status":100,"city":915,"state":13,"zip":916,"country":917,"countryCode":918,"cosmosGeoPoint":919,"geoPoint":923,"contacts":924},"Auckland City Hospital","Auckland","1010","New Zealand","NZ",{"type":107,"coordinates":920},[921,922],174.76349,-36.84853,{"lat":922,"lon":921},[925],{"name":926,"role":90,"phone":927,"phoneExt":13,"email":928},"Jithendra Somaratne, MD","6493074949","jithendras@adhb.govt.nz",{"facility":930,"status":100,"city":931,"state":13,"zip":932,"country":933,"countryCode":13,"cosmosGeoPoint":934,"geoPoint":938,"contacts":939},"Samsung Medical Center","Seoul","06351","South Korea",{"type":107,"coordinates":935},[936,937],126.9784,37.566,{"lat":937,"lon":936},[940],{"name":941,"role":90,"phone":942,"phoneExt":13,"email":943},"Joo Myung Lee, MD","+82-2-3410-2575","drone80@hanmail.net",{"facility":945,"status":100,"city":946,"state":13,"zip":947,"country":948,"countryCode":949,"cosmosGeoPoint":950,"geoPoint":954,"contacts":955},"Hospital Universitario de La Princesa","Madrid","28006","Spain","ES",{"type":107,"coordinates":951},[952,953],-3.70256,40.4165,{"lat":953,"lon":952},[956],{"name":957,"role":90,"phone":958,"phoneExt":13,"email":959},"Fernando Alfonso, MD","+34913303283","falf@hotmail.com",{"facility":961,"status":100,"city":962,"state":13,"zip":963,"country":948,"countryCode":949,"cosmosGeoPoint":964,"geoPoint":968,"contacts":969},"Hospital Universitario y Politécnico La Fe","Valencia","46026",{"type":107,"coordinates":965},[966,967],-0.37966,39.47391,{"lat":967,"lon":966},[970],{"name":971,"role":90,"phone":972,"phoneExt":13,"email":973},"Jorge Sanz, MD","+34961244000","sjorge4@gmx.com",{"facility":975,"status":100,"city":976,"state":13,"zip":977,"country":948,"countryCode":949,"cosmosGeoPoint":978,"geoPoint":982,"contacts":983},"Clínico de Valladolid","Valladolid","47012",{"type":107,"coordinates":979},[980,981],-4.72353,41.65541,{"lat":981,"lon":980},[984],{"name":985,"role":90,"phone":986,"phoneExt":13,"email":987},"Ignacio Amat-Santos, MD","+34657923040","ijamat@gmail.com",{"type":989,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"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":999,"type":1000},1616,"ESTIMATED","INTERVENTIONAL",[1003],"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.",[1006,1007],"Coronary Arterial Disease (CAD)","de Novo Lesions in Native Coronary Arteries",[1009,1010,1011],"Drug Coated Balloon","de novo","97279374","2026-07-01",{"date":1014,"type":1015},"2026-07-02","ACTUAL",{"date":1017,"type":1015},"2025-08-21",{"date":1019,"type":1000},"2032-03",{"name":5,"class":6},62]