[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"thoracoabdominal-aortic-aneurysm-dissecting\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:thoracoabdominal-aortic-aneurysm-dissecting":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100501000","thoracoabdominal-aortic-stent-system-for-endovascular-treatment-of-thoracoabdominal-aortic-dissecting-aneurysm-100501000",false,"NCT05803564","Thoracoabdominal Aortic Stent System for Endovascular Treatment of Thoracoabdominal Aortic Dissecting Aneurysm.","Clinical Application of a New Technique of Thoracoabdominal Aortic Stent System for Endovascular Treatment of Thoracoabdominal Aortic Dissecting Aneurysm.","Inclusion Criteria:\n\n1. Patients aged greater than 18 years old and less than 80 years old;\n2. Patients diagnosed with thoraco-abdominal aortic dissecting aneurysm and at least one of the following conditions should be met:\n\n   a)Maximum aneurysm diameter \\>50 mm; b）Increase in diameter by more than 5 mm in recent 6 months c）Symptoms such as abdominal pain and back pain associated with thoracic and abdominal aortic dissecting aneurysm were identified.\n\n   d）Poor morphology of thoracic and abdominal aortic dissecting aneurysm; e）Aortic dissection tears to iliac artery resulting in common iliac artery dissection tumor diameter \\>40 mm;\n3. Anatomic criteria\n\n   a)The diameter of the proximal anchoring area (aorta or implanted graft) ranged from 17\\~36 mm to ≥25 mm in length; b）Distal anchoring area (aorta or implanted graft): If distal anchoring area is in iliac artery, anchoring area diameter range 7\\~25 mm, length ≥15 mm; If the distal anchoring area is in the abdominal aorta, the anchoring area has a diameter of 12\\~36 mm and a length of ≥20 mm; c）There is a normal anchoring area at the distal end of the visceral branch vessel. The diameter range of the anchoring area is 6\\~13 mm and the length is ≥15 mm.\n\n   d）Normal anchoring zone at distal renal artery, anchoring zone diameter 4.5\\~9 mm, length ≥15 mm; e）Suitable iliac, femoral, and upper limb arterial access.\n4. Patients who understand the purpose of the trial, volunteer to participate and sign the informed consent form, and are willing to complete follow-up as required by the protocol;\n\nExclusion Criteria:\n\n1. Patients with severe hematoma in aortic wall in proximal anchoring area of stent\n2. Patients requiring simultaneous coverage and embolization of bilateral internal iliac arteries;\n3. Patients with a history of acute coronary syndrome within 6 months; Acute coronary syndromes are cardiac acute ischemic syndromes resulting from rupture of an unstable atherosclerotic plaque in the coronary artery or erosion secondary to the formation of new blood 4 thrombus, including ST-elevation myocardial infarction, non-ST-elevation myocardial infarction, and unstable angina.\n4. Patients with a transient ischemic attack (TIA) or ischemic\u002Fhemorrhagic stroke within 3 months;\n5. Patients with preoperative hepatic and renal dysfunction \\[alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 5 times the normal upper limit; Serum creatinine (Cr) \\>150u mol\u002FL\\];\n6. Patients with severe pulmonary insufficiency who cannot tolerate general anesthesia;\n7. Patients with severe coagulopathy;\n8. Patients with a history of hypersensitivity to contrast agents, anticoagulants, antiplatelet agents, stent delivery devices (i.e., nitinol, polyester, PTFE, nylon polymer materials);\n9. Patients with connective tissue diseases such as systemic lupus erythematosus, Marfan syndrome, Egyptian syndrome, or Behcet's disease;\n10. Patients with arteritis;\n11. Patients with significant organ dysfunction or other serious disease;\n12. Women with planned pregnancy, pregnancy stage , or lactation;\n13. The patient participated in another clinical trial and was not out or withdrawn within the first 3 months of the screening period of this trial.\n14. Patients with a life expectancy of not more than 1 year;\n15. Patients judged by the investigator to be unsuitable for endovascular treatment;","ALL","18 Years","80 Years",{"count":20,"type":21},46,"ESTIMATED","INTERVENTIONAL",[24],"NA","A First in man study to evaluate the safety and efficacy of thoracoabdominal aortic stent system for endovascular treatment of thoracoabdominal aortic dissecting aneurysm.",[27],"Thoracoabdominal; Aortic, Aneurysm, Dissecting",[29,30,31],"Thoracoabdominal aortic stent system","thoracoabdominal aortic dissecting aneurysm","G-Branch","RECRUITING","2025-06-17",{"date":35,"type":36},"2025-06-22","ACTUAL",{"date":38,"type":36},"2021-10-01",{"date":40,"type":21},"2027-10-01",{"name":42,"class":43},"Lifetech Scientific (Shenzhen) Co., Ltd.","INDUSTRY",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":44},"100402744","frailty-and-physician-modified-fenestrated-endograft-for-thoracoabdominal-aortic-pathologies-100402744","NCT04524247","Frailty and Physician Modified Fenestrated Endograft for Thoracoabdominal Aortic Pathologies","Impact of Frailty on Clinical Outcomes of Patients Treated for Thoracoabdominal and Complex Abdominal Aortic Aneurysms With Physician-Modified Fenestrated and Branched Stent Grafts","Inclusion Criteria:\n\n* Patients may be included in the study if the patient has at least one of the following indications and are anatomically appropriate for treatment with fenestrated\u002Fbranched stent grafts.\n\n  1. Pararenal, paravisceral, and type I to IV thoracoabdominal aortic aneurysms or chronic post-dissection aneurysms with a diameter 5cm or 2 times the normal aortic diameter.\n  2. Aneurysm with a history of growth ≥ 0.5cm per year.\n  3. Saccular aneurysms deemed at significant risk for rupture based on physician interpretation.\n  4. Symptomatic aneurysm without hemodynamic instability\n  5. Aneurysms meeting any of the above criteria 1\\~4, above or below the previous endovascular and\u002For open aortic repairs. Previously placed aortic stent graft or open aortic grafts may serve as seal zones.\n\nExclusion Criteria:\n\n* Patients must be excluded from the study if any of the following conditions is true:\n\n  1. Less than 18 years of age.\n  2. Unwilling to comply with the follow-up schedule.\n  3. Inability or refusal to give informed consent by the patient or a legally authorized representative.\n  4. Pregnant or breastfeeding.\n  5. Life-expectancy less than 2 years.\n  6. Participation in another investigational clinical or device trial, with the exception of participation in another investigational endovascular stent-graft protocol and performed remotely from the fenestrated procedure (\\>30 days). Examples include remote (\\>30days) participation in a thoracic, or abdominal branch device trial.\n  7. Eligible for treatment with FDA-approved marketed device.\n  8. Eligible and willing to travel to a center with IDE protocol wherein the device is made by a manufacturer.",{"count":53,"type":21},100,[24],"The primary objective of this single arm, prospective feasibility study, Impact of Frailty on Clinical Outcomes of Patients Treated for Thoracoabdominal and Complex Abdominal Aortic Aneurysms with Physician-Modified Fenestrated and Branched Stent Grafts, is to assess the use of the physician-modified fenestrated\u002Fbranched endografts to repair thoracoabdominal and complex aortic aneurysms in subjects having appropriate anatomy, at high risks for open repairs. The primary intent of the study is to assess safety and preliminary effectiveness of the device acutely (i.e., treatment success and technical success), at 30 days (i.e., the rate of major adverse events (MAE)) and at 3 months, 6 months, 12 months, and annually to 5 years (i.e., the proportion of treatment group subjects that achieve and maintain treatment success).\n\nAdditionally, this study will assess the degree of patient frailty before and after the aneurysm repair, as well as the association between the preoperative baseline frailty and clinical outcomes detailed above. This will help improve subject selection in identification of high risk patients who would not only suffer poor clinical outcomes, but also experience decline in their functional status.",[57,27,58,59],"Thoracoabdominal Aortic Aneurysm","Pararenal Aneurysm","Frailty Syndrome","2024-06-28",{"date":62,"type":36},"2024-07-01",{"date":64,"type":36},"2021-02-23",{"date":66,"type":21},"2032-07-02",{"name":68,"class":69},"University of Southern California","OTHER"]