[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100515956":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":20,"locations":21,"responsibleParty":47,"collaborators":20,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":20,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":20,"enrollmentInfo":58,"targetDuration":20,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":20,"overallStatus":67,"whyStopped":20,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"BrosMed Medical Co., Ltd","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Alveo balloon dilatation catheter","EXPERIMENTAL","Subjects who meet the inclusion criteria and agree to participate in the study will be enrolled and undergo a planned percutaneous coronary intervention with Alveo balloon dilatation catheter.",[13],"Device: Alveo HP Balloon Dilatation Catheter",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Alveo HP Balloon Dilatation Catheter","Alveo HP Balloon is intended for dilatation of stenosis in the coronary artery.",[9],null,[22,28,38],{"facility":23,"status":20,"city":24,"state":25,"zip":20,"country":26,"countryCode":27,"cosmosGeoPoint":20,"geoPoint":20,"contacts":20},"The Seventh People's Hospital of Zhengzhou","Zhenzhou","Henan","China","CN",{"facility":29,"status":20,"city":30,"state":31,"zip":20,"country":26,"countryCode":27,"cosmosGeoPoint":32,"geoPoint":37,"contacts":20},"Renmin Hospital of Wuhan University Hubei General Hospital","Wuhan","Hubei",{"type":33,"coordinates":34},"Point",[35,36],114.26667,30.58333,{"lat":36,"lon":35},{"facility":39,"status":20,"city":40,"state":41,"zip":20,"country":26,"countryCode":27,"cosmosGeoPoint":42,"geoPoint":46,"contacts":20},"Shanxi Cardiovascular Hospital","Taiyuan","Shanxi",{"type":33,"coordinates":43},[44,45],112.56028,37.86944,{"lat":45,"lon":44},{"type":48,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100515956","evaluate-safety-and-efficacy-of-alveo-hp-balloon-dilatation-catheter-for-balloon-dilatation-of-coronary-artery-stenosis-100515956",false,"NCT05998252","Evaluate Safety and Efficacy of Alveo HP Balloon Dilatation Catheter for Balloon Dilatation of Coronary Artery Stenosis","A Post-Market Study to Evaluate Safety and Efficacy of Alveo HP Balloon Dilatation Catheter for Balloon Dilatation of Coronary Artery Stenosis","Inclusion Criteria:\n\n1. Age ≥ 18 years old, gender is not limited;\n2. Patients with symptomatic ischemic heart disease who are suitable for percutaneous coronary intervention (PCI);\n3. Patients with target lesion diameter stenosis ≥ 70% (visually) or chronic total occlusion (CTO) who needed balloon dilatation catheter pre-dilatation;\n4. Patients or their guardians who can understand the purpose of the trial, voluntarily participate and sign the written informed consent, and can accept follow-up;\n\nExclusion Criteria:\n\n1. Patients with clinical symptoms consistent with ST-segment elevation myocardial infarction or\u002Fand ECG changes within 12 hours prior to the procedure;\n2. Patients who are known to be intolerant to antiplatelet drugs or allergic to contrast media;\n3. Patients with in-stent restenosis;\n4. Patients with unprotected left main coronary artery disease;\n5. Patients who plan to treat 3 or more lesions at the same time;\n6. Patients with severe calcified lesions;\n7. Patients in whom the guidewire cannot pass through the lesion;\n8. Women who are pregnant or lactating;\n9. Patients who are participating in the clinical trial of other drugs or medical devices;\n10. Other patients considered by the investigator to be unsuitable for this trial.","ALL","18 Years",{"count":59,"type":60},60,"ACTUAL","INTERVENTIONAL",[63],"NA","This is a prospective, multi-center, single-group study aims to evaluate the safety and efficacy of Alveo HP Balloon Dilatation Catheter for balloon dilatation of coronary artery stenosis. Pre-dilation with Alveo balloon dilatation catheter followed by conventional PCI, and follow-up will be carried out. During the trial, the enrollment, treatment and follow-up of the subjects will be recorded, and the safety and efficacy of the investigational device will be evaluated.",[66],"Coronary Artery Disease","COMPLETED","2024-01-08",{"date":70,"type":60},"2024-01-10",{"date":72,"type":60},"2022-12-27",{"date":74,"type":60},"2023-12-08",{"name":5,"class":6},3]