[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100443483":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":49,"collaborators":20,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":20,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":20,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":34,"whyStopped":20,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Lifetech Scientific (Shenzhen) Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention arm","EXPERIMENTAL","Patients with thoracoabdominal aortic aneurysms, and passed the screening and signed the informed consent form.",[13],"Device: Multi-Branched Thoracoabdominal Stent Graft System",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Multi-Branched Thoracoabdominal Stent Graft System","Patients who meet all the inclusion criteria and don't meet the exclusion criteria will be implanted with multi-branched thoracoabdominal stent graft system .",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Wei Guo, Professor","Chinese PLA General Hospital","PRINCIPAL_INVESTIGATOR",[27],{"name":23,"role":28,"phone":29,"phoneExt":30,"email":31},"CONTACT","13910758706","86","pla301dml@vip.sina.com",[33],{"facility":24,"status":34,"city":35,"state":36,"zip":20,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"RECRUITING","Beijing","Beijing Municipality","China","CN",{"type":40,"coordinates":41},"Point",[42,43],116.39723,39.9075,{"lat":43,"lon":42},[46,48],{"name":47,"role":28,"phone":20,"phoneExt":20,"email":20},"Wei Guo",{"name":47,"role":25,"phone":20,"phoneExt":20,"email":20},{"type":50,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100443483","safety-and-efficacy-of-a-multi-branched-thoracoabdominal-stent-graft-system-for-thoracoabdominal-aortic-aneurysm-100443483",false,"NCT05054985","Safety and Efficacy of a Multi-branched Thoracoabdominal Stent Graft System for Thoracoabdominal Aortic Aneurysm.","Guo's Renovisceral Artery Reconstruction-1: a Prospective, Multicenter, Single-arm Clinical Trial to Evaluate the Safety and Efficacy of a Multi-branched Stent Graft System for Thoracoabdominal Aortic Aneurysm (GUARANTEE Study)","Inclusion Criteria:\n\n1. 18 years old ≤ age ≤ 80 years old;\n2. Diagnosed as thoracoabdominal aortic aneurysm (based on modified Crawford classification and 2019 European Guidelines for the Treatment of Aortic aneurysm) and should meet at least one of the following conditions;\n\n   1. Maximum diameter of thoracoabdominal aortic aneurysm\\>50mm;\n   2. The diameter has increased by more than 5mm in recent 6 months or the by more than 10mm in recent 1 year;\n3. anatomical criteria\n\n   1. The proximal anchoring region (aorta or implanted graft) was 17\\~36 mm in diameter and ≥25 mm in length;\n   2. Distal anchoring region (aorta or implanted graft): If the distal anchoring region is in the iliac artery, the anchoring region has a diameter range of 7\\~25 mm and a length of ≥15 mm; If the distal anchoring area is in the abdominal aorta, the diameter of the anchoring area ranges from 12\\~36mm and the length≥ 20mm;\n   3. The diameter of the vessel anchoring area of the visceral branch ranges from 6\\~13 mm and the length ≥15 mm;\n   4. The diameter of renal artery anchoring area ranges from 4.5\\~9mm, and the length ≥15 mm;\n   5. Appropriate iliac, femoral and upper limb artery access;\n4. Patients who can understand the purpose of the trial, voluntarily participate and sign the informed consent, and are willing to complete the follow-up according to the requirements of the protocol;\n\nExclusion Criteria:\n\n1. Hemodynamically unstable patients with ruptured thoracoabdominal aortic aneurysms;\n2. Thoracoabdominal aortic dissection;\n3. Mycotic or infectious thoracoabdominal aortic aneurysm;\n4. Patients whose systemic or local infection may increase the risk of intravascular graft infection;\n5. Superior mesenteric, celiac, or renal artery occlusion;\n6. Requiring simultaneous coverage and embolization of bilateral internal iliac arteries;\n7. Severe stenosis, calcification, or mural thrombus in the anchoring area of the stent tend to have difficulty in attachment of the stent-graft or affect the patency of the stent;\n8. A history of acute coronary syndrome within 6 months; Acute coronary syndrome is defined as an acute ischemic syndrome of the heart resulting from the rupture or erosion of unstable intracoronary atherosclerotic plaques followed by fresh thrombosis, including ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction, and unstable angina pectoris.\n9. Transient ischemic attack (TIA) or ischemic\u002Fhaemorrhagic stroke within 3 months;\n10. Preoperative liver renal function abnormalities (ALT or AST ≥ 5 times the upper limit of normal value), or serum creatinine ≥ 150 μmol\u002FL;\n11. Severe pulmonary insufficiency who cannot tolerate general anaesthesia;\n12. Severe coagulation dysfunction;\n13. Undergone major surgical or interventionic surgery within 30 days before surgery;\n14. A history of allergy to contrast agents, anticoagulants, antiplatelet drugs, stents, and conveyor materials (nitinol, polyester, PTFE, nylon);\n15. Connective tissue diseases such as systemic lupus erythematosus, Marfan's syndrome, Adam's syndrome, or Behcet's disease;\n16. takayasu arteritis;\n17. Serious vital organ dysfunction or other serious disease;\n18. Planning pregnancy, pregnancy, or breastfeeding;\n19. Patients who participated in other clinical trials and was not discontinued or withdrawn within the first 3 months of the screening period of this trial.\n20. Life expectancy less than 1 year;\n21. Patients who, in the judgment of the investigator, are not eligible for endotherapy.","ALL","18 Years","80 Years",{"count":62,"type":63},73,"ESTIMATED","INTERVENTIONAL",[66],"NA","Evaluation of the safety and efficacy of a multi-branched thoracoabdominal stent graft system for thoracoabdominal aortic aneurysm.",[69],"Thoracoabdominal Aortic Aneurysms",[71,72,73],"Guo's Visceral Arteries Reconstruction","Multi-branched Thoracoabdominal Stent Graft System","Thoracoabdominal Aortic Aneurysm","2025-06-17",{"date":76,"type":77},"2025-06-22","ACTUAL",{"date":79,"type":77},"2021-11-12",{"date":81,"type":63},"2028-12-31",{"name":5,"class":6},1]