[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606037":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":19,"responsibleParty":30,"collaborators":19,"id":32,"slug":33,"hasResults":34,"nctId":35,"briefTitle":17,"officialTitle":36,"acronym":19,"eligibilityCriteria":37,"healthyVolunteers":34,"sex":38,"minAge":39,"maxAge":40,"enrollmentInfo":41,"targetDuration":19,"studyType":44,"phases":45,"briefSummary":47,"conditions":48,"keywords":50,"overallStatus":53,"whyStopped":19,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":19},{"fullName":5,"class":6},"Hangzhou Endonom Medtech Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental","EXPERIMENTAL","The ZIPPER aortic arch stentgraft system consists of the arch mainbody stentgraft system, the branch artery stentgraft system and the thoracic extension stentgraft system.",[13],"Device: ZIPPER™ Stent-Graft Trial for Aortic Arch Dissection",[15],{"type":16,"name":17,"description":11,"armGroupLabels":18,"otherNames":19},"DEVICE","ZIPPER™ Stent-Graft Trial for Aortic Arch Dissection",[9],null,[21,26],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Zhang Wayne W, Medical Doctorate","CONTACT","+8615895901908","wwzhang08@gmail.com",{"name":27,"role":23,"phone":28,"phoneExt":19,"email":29},"Fu Weiguo, Medical Doctorate","+8613801760929","fu.weiguo@zs-hospital.sh.cn",{"type":31,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100606037","zipper-stent-graft-trial-for-aortic-arch-dissection-100606037",false,"NCT07170332","Clinical Study on the Safety and Efficacy of the ZIPPER™ Aortic Arch Stent-Graft System in the Treatment of Aortic Arch Dissection","Inclusion Criteria:\n\n* Age: 18-80 years of age.\n\nDiagnosis and Anatomical Suitability:\n\nSubacute or chronic aortic arch dissection requiring intervention, where the proximal end of the stent graft requires anchoring in Zone 0, and meets the following vascular anatomical criteria:\n\nAscending aorta (may include graft segments) ≥ 40 mm in length (measured from the sinotubular junction to the proximal edge of the IA along the centerline).\n\nProximal landing zone diameter ≥ 24 mm and ≤ 47 mm. Proximal landing zone length ≥ 20 mm. Diameters of the IA, LCCA, and LSA ≤ 24 mm and ≥ 6 mm, with lengths ≥ 20 mm. Suitable arterial access for endovascular intervention. Informed Consent: Capable of understanding the study purpose, voluntarily agreeing to participate, and providing written informed consent (by the subject or their legal representative). Willing to comply with follow-up requirements per the protocol.\n\nSurgical Risk Assessment: Deemed high surgical risk (evaluated by at least two independent vascular or cardiac surgeons) or confirmed to have significant contraindications to open surgery.\n\nExclusion Criteria:\n\n* Prior aortic intervention: History of open or endovascular repair of the descending or abdominal aorta.\n\nConcurrent AAA requiring intervention: Coexisting abdominal aortic aneurysm requiring surgical intervention within 30 days.\n\nSpecific aortic pathologies: infectious aortitis, Takayasu arteritis, Marfan syndrome, or other connective tissue disorders.\n\nActive systemic infection: Ongoing systemic infection or high risk of systemic infection.\n\nSevere arch vessel disease: Severe stenosis, calcification, thrombosis, or tortuosity of the IA, LCCA, or LSA.\n\nAcute ischemia: Bowel necrosis or lower limb ischemic necrosis. Pre-existing paraplegia. Post-cardiac transplant status. Recent cardiovascular events: Myocardial infarction or stroke within the past 3 months.\n\nAdvanced heart failure: NYHA Class IV or left ventricular ejection fraction (LVEF) \\\u003C30%.\n\nActive gastrointestinal bleeding: Active peptic ulcer or upper gastrointestinal bleeding within the past 3 months.\n\nHematologic abnormalities: Leukopenia (WBC \\\u003C 3×10⁹\u002FL), Anemia (Hb \\\u003C 90 g\u002FL), Coagulopathy, Thrombocytopenia (platelets \\\u003C 50×10⁹\u002FL).\n\nRenal insufficiency: Serum creatinine \\> 221 μmol\u002FL (2.5 mg\u002FdL) or end-stage renal disease requiring dialysis (investigator discretion).\n\nSevere hepatic dysfunction: ALT\u002FAST \\> 5× upper limit of normal (ULN), Serum total bilirubin (STB) \\> 2× ULN.\n\nHigh-risk intracranial lesions (any of the following):\n\n1. Unruptured aneurysm ≥7 mm (anterior circulation) or ≥5 mm (posterior circulation)\n2. Prior rupture or high-risk morphology (daughter sac, aspect ratio \\>1.6)\n3. Intracranial arterial stenosis ≥50% with poor collateral flow. Contrast allergy. Pregnancy or lactation. Anesthesia\u002Fsurgery contraindications: Severe comorbidities precluding tolerance to anesthesia or surgery.\n\nLife expectancy \\\u003C 12 months. Current participation in other drug or device clinical trials. Other exclusions: Any conditions deemed unsuitable for participation by the investigator.","ALL","18 Years","80 Years",{"count":42,"type":43},127,"ESTIMATED","INTERVENTIONAL",[46],"NA","This study is the feasible study on a new technique of ZIPPER aortic arch stentgraft system",[49],"Dissection of Aortic Arch",[51,52],"Aortic Arch","Dissection","NOT_YET_RECRUITING","2025-09-11",{"date":56,"type":57},"2025-09-15","ACTUAL",{"date":59,"type":43},"2025-09-30",{"date":61,"type":43},"2032-09-30",{"name":5,"class":6}]