[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571547":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":20,"locations":21,"responsibleParty":44,"collaborators":46,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":20,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":20,"enrollmentInfo":59,"targetDuration":20,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":73,"whyStopped":20,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Peijia Medical Technology (Suzhou) Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"A single arm study","EXPERIMENTAL","The experimental apparatus consisted of artificial aortic valve, transporter and grip-loading system.the transporter has A2 flex function to improve coaxiality and commissural aligment to reduce coronary occlusion",[13],"Device: transcatheter aortic valve replacement in severe aortic stenosis",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","transcatheter aortic valve replacement in severe aortic stenosis","transcatheter aortic valve replacement with A² Flex and commissural alignment technology in severe aortic stenosis",[9],null,[22],{"facility":23,"status":20,"city":24,"state":25,"zip":26,"country":27,"countryCode":28,"cosmosGeoPoint":29,"geoPoint":34,"contacts":35},"Peiga Medical Technology (Suzhou) Co., Ltd, Suzhou, Jiangsu 215025","Suzhou","Jiangsu","215025","China","CN",{"type":30,"coordinates":31},"Point",[32,33],120.59538,31.30408,{"lat":33,"lon":32},[36,41],{"name":37,"role":38,"phone":39,"phoneExt":20,"email":40},"jing jing","CONTACT","18550112597","renjing@peijiamedical.com",{"name":42,"role":43,"phone":20,"phoneExt":20,"email":20},"daxin zhou, professor","SUB_INVESTIGATOR",{"type":45,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[47],{"name":48,"class":49},"Shanghai Zhongshan Hospital","OTHER","100571547","study-of-transcatheter-aortic-valve-replacement-with-a-flex-and-commissural-alignment-technology-in-severe-aortic-stenosis-100571547",false,"NCT06721676","Study of Transcatheter Aortic Valve Replacement With A² Flex and Commissural Alignment Technology in Severe Aortic Stenosis","A Prospective, Single-center, Single-group Follow-up Study of Transcatheter Aortic Valve Replacement With A² Flex and Commissural Alignment Technology in Severe Aortic Stenosis by Peijia Medical","Inclusion Criteria:\n\n* Patients who are willing to participate and sign the informed consent and can cooperate with the whole trial process;\n* Age ≥60 years old;\n* Patients with severe calcified aortic stenosis confirmed by echocardiography (trans-aortic valve flow velocity ≥ 4.0m \u002Fs, or trans-active valvular pressure difference ≥40mmHg (1mmHg=0.133kPa), or aortic valve orientation area \\\u003C 0.8cm2, or effective aortic valve orifice the product index is \\\u003C 0.5cm2\u002Fm2);\n* The cardiac team (at least two specialists in cardiovascular surgery) assessed the patient as unsuitable for routine surgery ;\n* The aortic angel ≥60 degree.\n\nExclusion Criteria:\n\n* The left and right coronary ostiums originate from the junctional zone or from both coronary ostiums;\n* previous CABG history;\n* Coronary ostial lesions（PCI or not）;\n* Prior aortic valve prosthesis implantation (interventional\u002Fsurgical, bioprosthetic\u002Fmechanical);\n* Spoor peripheral arterial condition precluded transfemoral TAVR;\n* Severe coronary stenoses requiring intervention for which concomitant PCI is not possible;\n* Concomitant diseases requiring cardiac surgery;\n* Other serious diseases that may reduce life expectancy to less than 12 months (e.g. clinically recurrent or metastatic cancer, congestive heart failure, etc.);\n* contraindications to conventional cardiac catheterization, such as intracardiac thrombosis, infection, outflow obstruction, hypertrophic cardiomyopathy, etc;\n* other surgical anatomical contraindications, such as the risk of coronary artery occlusion;\n* clinically significant active bleeding\n* platelet count \\\u003C 30×10\u002F L;\n* participating in other drug or medical device clinical studies that have not yet been completed ;\n* considered inappropriate by the investigator to participate in the clinical study.","ALL","60 Years",{"count":60,"type":61},10,"ESTIMATED","INTERVENTIONAL",[64],"NA","A prospective, single-center, single-group follow-up study of transcatheter aortic valve replacement with A² Flex and commissural alignment technology in severe aortic stenosis by Peijia Medical",[67],"Aortic Stenosis Symptomatic",[69,70,71,72],"aortic stenosis","TAVI","TAVR","Function of bending","NOT_YET_RECRUITING","2024-12-03",{"date":76,"type":77},"2024-12-06","ACTUAL",{"date":79,"type":61},"2024-12",{"date":81,"type":61},"2025-06-30",{"name":5,"class":6},1]