[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659671":3},{"organization":4,"outcomesModule":7,"designInfo":23,"detailedDescription":26,"studyPopulation":27,"armGroups":28,"interventions":34,"overallOfficials":22,"centralContacts":40,"locations":46,"responsibleParty":69,"collaborators":72,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":78,"sex":84,"minAge":85,"maxAge":22,"enrollmentInfo":86,"targetDuration":22,"studyType":89,"phases":22,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":96,"whyStopped":22,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Yonsei University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":22},[9],{"measure":10,"description":11,"timeFrame":12},"Successful lesion expansion with Angionix Balloon","Successful lesion expansion is defined as achievement of less than 50% stenosis of the original vessel diameter in the target stenotic lesion treated with Angionix Balloon.","During the procedure (immediately after balloon dilatation)",[14,18],{"measure":15,"description":16,"timeFrame":17},"Final procedural success","Final procedural success is defined as successful balloon angioplasty (minimum diameter stenosis \\\u003C 30% + final TIMI flow grade 3 without fatal complications during procedure for DCB\u002FPOBA) or successful stent implantation (minimum diameter stenosis \\\u003C 20% + final TIMI flow grade 3 without fatal complications during procedure).","At the end of the PTCA procedure",{"measure":19,"description":20,"timeFrame":21},"Incidence of fatal complications during procedure","Occurrence of fatal complications during the procedure, defined as: perforation, cardiac tamponade, emergent operation, intraprocedural stent thrombosis, no reflow \u002F acute closure, distal embolization, side branch occlusion, or stent migration.","Periprocedural",null,{"allocation":22,"interventionModel":22,"interventionModelDescription":22,"primaryPurpose":22,"observationalModel":24,"timePerspective":25,"maskingInfo":22},"COHORT","PROSPECTIVE","This study is designed to evaluate the safety and efficacy of the Angionix Balloon-a domestically developed coronary balloon dilatation catheter-when used in percutaneous coronary angioplasty (PTCA) for patients with coronary artery disease.\n\nThe main objectives are to assess procedural success rates, vessel expansion success, and the occurrence of major complications during real-world clinical use in lesion preparation and stent post-dilation.","Adult patients with coronary artery disease who visit participating medical centers and are scheduled to undergo percutaneous transluminal coronary angioplasty (PTCA) using Angionix Balloon or Angionix NC Balloon in routine clinical practice.",[29],{"label":30,"type":22,"description":31,"interventionNames":32},"Angionix Registry Cohort","Adult patients aged 19 years or older with coronary artery disease who require percutaneous transluminal coronary angioplasty (PTCA) using Angionix Balloon or Angionix NC Balloon.",[33],"Device: Angionix Balloon",[35],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":22},"DEVICE","Angionix Balloon","Percutaneous transluminal coronary angioplasty (PTCA) balloon dilatation catheter (Angionix Balloon and Angionix NC Balloon) used for lesion preparation and post-stent dilation in patients with coronary artery disease. Balloon dilatation is performed at nominal pressure or higher for approximately 5 to 10 seconds according to standard clinical procedure.",[30],[41],{"name":42,"role":43,"phone":44,"phoneExt":22,"email":45},"Yongcheol Kim, MD.,PhD","CONTACT","821058084029","yongcheol@yuhs.ac",[47,53,58],{"facility":48,"status":22,"city":49,"state":50,"zip":51,"country":52,"countryCode":22,"cosmosGeoPoint":22,"geoPoint":22,"contacts":22},"Yongcheol Kim","Yongin","Gyeonggi-do","16995","South Korea",{"facility":54,"status":22,"city":55,"state":56,"zip":57,"country":52,"countryCode":22,"cosmosGeoPoint":22,"geoPoint":22,"contacts":22},"Kyungpook National University College Hospital","Daegu","Gyeongsangnam-do","136-705",{"facility":59,"status":22,"city":60,"state":61,"zip":62,"country":52,"countryCode":22,"cosmosGeoPoint":63,"geoPoint":68,"contacts":22},"Jeonbuk National University Hospital","Jeonju","Jeollabuk-do","54907",{"type":64,"coordinates":65},"Point",[66,67],127.14889,35.82194,{"lat":67,"lon":66},{"type":70,"investigatorFullName":48,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"PRINCIPAL_INVESTIGATOR","Professor (Division of Cardiology)",[73],{"name":74,"class":75},"NOBAMEDI CO., LTD.","UNKNOWN","100659671","efficacy-and-safety-of-the-angionix-balloon-in-patients-with-coronary-artery-disease-undergoing-ptca-100659671",false,"NCT07869602","Efficacy and Safety of the Angionix Balloon in Patients With Coronary Artery Disease Undergoing PTCA","A Multi-center, Registry Evaluating the Efficacy and Safety of the Use of Angionix Balloon in Patient With Coronary Artery Disease","Angionix","Inclusion Criteria:\n\n1. Adult aged 19 years or older at baseline\n2. Patients diagnosed with coronary artery disease\n3. Patients requiring percutaneous transluminal coronary angioplasty (PTCA) with Angionix Balloon or Angionix NC Balloon\n4. Patients who voluntarily agree to participate in this study and sign an informed consent form\n\nExclusion Criteria:\n\n1. Patients presenting with cardiogenic shock based on the investigator's clinical judgment\n2. Patients with vessel dissection already identified on coronary angiography prior to PTCA procedure based on the investigator's clinical judgment\n3. Pregnant or lactating women\n4. Patients who have other clinically significant findings that make them unsuitable for study participation based on the investigator's medical judgment","ALL","19 Years",{"count":87,"type":88},600,"ESTIMATED","OBSERVATIONAL","A Multi-center, Registry evaluating the efficacy and safety of the use of Angionix Balloon in Patient with Coronary Artery Disease",[92],"Coronary Artery Disease",[94,95,82],"coronary artery disease","balloon","NOT_YET_RECRUITING","2026-10-06",{"date":99,"type":100},"2026-10-09","ACTUAL",{"date":102,"type":88},"2026-11-09",{"date":104,"type":88},"2028-07-01",{"name":5,"class":6},3]