[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"thoracoabdominal-aortic-aneurysm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:thoracoabdominal-aortic-aneurysm":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,18,0,[8,43,66,96,119,141,182,209,238,264,303,325,356,388,408,433,455,475],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100632789","comparison-of-femorofemoral-bypass-and-left-heart-bypass-techniques-in-open-thoracoabdominal-aortic-aneurysm-repair-100632789",false,"NCT07518251","CompaRison of FEmorofemoral Bypass and Left-Heart ByPass Techniques in Open Thoracoabdominal AortIc Aneurysm Repair","Comparison of Femorofemoral Bypass and Left-Heart Bypass Techniques in Open Thoracoabdominal Aortic Aneurysm Repair: A Study Protocol for Multicenter, Two-Arm, Open-Label, Randomized, ParalleI-Controlled Non-Inferiority Trial","REPAIR","Inclusion Criteria:\n\n1. Computed tomography angiography (CTA) confirmed as ATAAD according to the 2022 ACC\u002FAHA Guideline for the Diagnosis and Management of Aortic Disease;\n2. Adult patients (≥18 years old);\n3. Indications for TAAAR are available and requiring cardiopulmonary bypass;\n4. Signed informed consent and availability for follow-up.\n\nExclusion Criteria:\n\n1. History of chronic renal failure, chronic heart failure, Coronary heart disease with established surgical indications, hepatocirrhosis, and hepatic insufficiency;\n2. History of severe cerebral infarction (with cerebral infarction sequels);\n3. Inflammatory aortic diseases, such as Takayasu arteritis and Behçet's disease, etc;\n4. History of infectious aortic diseases;\n5. History of malignancy or previous radiotherapy;\n6. Pregnant or feeding women, or anyone planning to reproduce during the test period;\n7. Participating in any other clinical trial;\n8. Having other causes not eligible for operation.","ALL","18 Years",{"count":20,"type":21},236,"ESTIMATED","INTERVENTIONAL",[24],"NA","The study is a multicenter, two-arm, open-label, randomized, parallel-controlled trial, which plans to enroll 236 participants diagnosed with TAAA from 4 hospitals in China. All patients receive TAAAR procedure and are randomized to control group (LHB) and experimental group (fCPB) in the ratio of 1:1. After a 1-year follow-up, the validity and safety of the different cardiopulmonary bypass for TAAAR is evaluated via the incidence of major adverse events including surgical mortality, RRT, stroke, and SCI, as well as intraoperative blood product transfusion volume, mechanical ventilation, and early mortality.",[27,28,29],"Thoracoabdominal Aortic Aneurysm","Cardiopulmonary Bypass","Open Repair","RECRUITING","2026-06-30",{"date":33,"type":34},"2026-07-01","ACTUAL",{"date":36,"type":34},"2026-03-06",{"date":38,"type":21},"2028-08",{"name":40,"class":41},"Beijing Anzhen Hospital","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":42},"100172879","evaluation-of-branch-endografts-in-the-treatment-of-aortic-aneurysms-100172879","NCT01524211","Evaluation of Branch Endografts in the Treatment of Aortic Aneurysms","Zenith t-Branch Eligibility Criteria:\n\nInclusion Criteria\n\nThe patient must have one of the following:\n\n1. Degenerative, atherosclerotic thoracoabdominal, suprarenal and juxtarenal aortic aneurysms (fusiform or saccular):≥55mm in diameter in a male or ≥50mm in diameter in a female, or\n2. Thoracoabdominal aortic aneurysm with a history of growth ≥0.5 cm per year, or\n3. Penetrating ulcers: ≥20mm in depth or\n4. Chronic type B aortic dissections: ≥50mm total aortic diameter or\n5. Symptomatic pathology (aneurysm, ulcer or chronic dissection) of any size.\n\nAdditional criteria for LP material\n\n• Iliofemoral access vessels \\\u003C8mm or with significant atherosclerotic occlusive disease that would require an iliac conduit as determined by the Principle Investigator\n\nExclusion Criteria\n\nGeneral Criteria\n\n1. Life-expectancy less than 12 months\n2. Refusal to receive blood products\n3. Age \\\u003C18 years\n4. Pregnant or breastfeeding or planning on becoming pregnant within 60 months\n5. Unwilling to comply with the follow-up schedule\n6. Inability or refusal to give informed consent by subject and\u002For Legally Authorized Representative (LAR); should one be utilized\n\nMedical Criteria\n\n1. Uncontrolled systemic infection\n2. Untreatable malignancy\n3. Uncontrollable anaphylaxis to iodinated contrast\n4. Known allergy(ies) to device materials\n\nAnatomic Criteria\n\n1. Any pathology of mycotic origin\n2. Aortic fistulous communication with non-vascular structure (e.g. esophagus, bronchial)\n3. Inability to insert the Zenith® t-Branch device through iliofemoral approach\n4. Proximal and distal neck angle less than 90 degrees relative to the long axis of the aneurysm\n5. Proximal landing zone length \\\u003C25mm to allow secure fixation and seal\n6. Proximal landing zone diameter of \\\u003C24mm or \\>42mm\n7. Distal landing zone length \\\u003C25mm in the abdominal aorta or \\\u003C20mm in the iliac arteries\n8. Distal landing zone diameter of \\\u003C14mm or \\>30mm in the abdominal aorta, or \\\u003C7mm or \\>28mm in the iliac arteries\n\nTerumo Arch Branch Eligibility Criteria\n\nInclusion Criteria\n\nThe subject must have one of the following:\n\n1. Degenerative, atherosclerotic aneurysm involving the ascending aorta, aortic arch or proximal descending aorta ≥55 mm in diameter or \\> 50 mm with a history of growth ≥5 mm in the last 6 months, or\n2. Penetrating ulcers: ≥20 mm in depth, or\n3. Chronic aortic dissections: ≥50mm total aortic diameter. AND Prohibitive or high-risk for standard open surgical repair, defined as having one or more of the following pre-existing conditions.\n\n   1. Age \\>85 years old.\n   2. Prior median sternotomy (for any reason).\n   3. Prior open or endovascular thoracic aortic repair.\n   4. Severe aortic calcification.\n   5. Severe occlusive disease of one or more arch vessels.\n   6. Moderate-severe COPD (FEV1 \\\u003C80% predicted).\n   7. Severe CKD (Stage 3 or greater, eGFR \\\u003C60 mL\u002Fmin).\n   8. LV dysfunction.\n   9. Chronic steroid or immunosuppressive use.\n   10. History of increased risk of bleeding.\n   11. Neurocognitive deficits that may significantly impact postoperative rehabilitation.\n   12. Musculoskeletal conditions that may significantly impact postoperative rehabilitation.\n\nExclusion Criteria\n\nGeneral Criteria\n\n1. Life expectancy \\\u003C1 year.\n2. Refusal to receive blood products.\n3. Age \\\u003C18 years.\n4. Pregnant, breastfeeding, or planning to become pregnant within 60 months.\n5. Unwilling to comply with the follow-up schedule.\n6. Inability or refusal to give informed consent by subject and\u002For Legally Authorized Representative (LAR); should one be utilized.\n7. Willingness to travel, if needed, to participate in a manufacturer-sponsored clinical trial at another institution.\n\nMedical Criteria\n\n1. Pending cardiac surgery.\n2. Untreatable severe, symptomatic coronary or valvular disease.\n3. Prior mechanical aortic valve replacement (not bioprosthetic).\n4. History of TAVR (Transcatheter Aortic Valve Replacement)\n5. Severe, calcific aortic valvular stenosis.\n6. Uncontrolled systemic infection.\n7. Untreatable malignancy with \\\u003C1 year expected survival.\n8. Uncontrollable anaphylaxis to iodinated contrast.\n9. Known allergy(ies) to device materials. (i.e. polyester, nitinol).\n\nAnatomic Criteria\n\n1. Any pathology of mycotic origin.\n2. Aortic fistulous communication with non-vascular structure (e.g. esophagus, bronchial).\n3. Acute (\\\u003C2 weeks) aortic dissection.\n4. Type A dissection.\n5. Symptomatic or ruptured pathology.\n6. Anatomy suitable for repair using commercially-available endograft.\n7. Inability to insert the Arch Branch endograft through an iliofemoral approach.\n8. Untreated, known extracranial carotid stenosis \\>80%.\n9. Ascending aortic angulation with radius of curvature \\\u003C15mm in the intended landing zone.\n10. Proximal aortic landing zone length \\\u003C25 mm.\n11. Proximal aortic landing zone diameter of \\>43mm or \\\u003C28 mm.\n12. Distal aortic landing zone diameter \\\u003C20 mm.\n13. Total length along the outer curve from the distal coronary to the proximal edge of the brachiocephalic trunk \\\u003C70mm.\n14. Target arch vessels:\n15. Distal branch landing zone dimensions: I. Brachiocephalic trunk (innominate artery, BCT): Diameter \\>24 mm or \\\u003C6 mm, length \\\u003C15 mm. ii. Common carotid artery: Diameter \\\u003C6 mm, length \\\u003C25mm. iii. Subclavian artery: Diameter \\\u003C6 mm, length \\\u003C25mm.",{"count":50,"type":21},235,[24],"Zenith t-Branch Study Cohort: The purpose of this study is to collect information on the Cook Zenith t-Branch endovascular stent-graft system and the Terumo Arch Branch for the treatment of aortic aneurysms.\n\nTerumo Arch Branch Study Cohort: The purpose of this additional study arm to the current IDE clinical trial is to collect a priori information on the Terumo Arch Branch Endograft for the treatment of proximal thoracic aortic pathologies that cannot be treated with conventional thoracic endografts.",[27,54],"Aortic Arch Aneurysm",[56],"Aortic Aneurysms","2026-06-12",{"date":59,"type":34},"2026-06-15",{"date":61,"type":34},"2012-01-25",{"date":63,"type":21},"2032-01",{"name":65,"class":41},"Baptist Health South Florida",{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":75,"phases":4,"briefSummary":76,"conditions":77,"keywords":80,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":5},"100508130","european-aortic-data-collection-project-100508130","NCT05896397","European Aortic Data Collection Project","EADC","Inclusion Criteria:\n\n1\\. Patients who will be treated with a Cook CMD\n\nExclusion Criteria:\n\n1. Patients who declare they are unable to complete clinical follow-up visit at the time of enrollment, or\n2. Patients or his\u002Fher legally authorized representative objects to extraction of patient's data from the medical record, or unwilling to sign the Informed Consent.",{"count":74,"type":21},600,"OBSERVATIONAL","The purpose of this study is to evaluate the safety and performance of Cook's various Custom-Made Stent-graft Devices (CMD) used for endovascular treatment of the aorta and related diseases by collecting information on the real-world use of the devices.\n\nThe study results will be used to support the continuation of the CMDs on the market. In addition, the study will support the manufacturers obligation for post market product surveillance as well as Cook's technology development.",[78,27,54,79],"Complex Abdominal Aortic Aneurysm","Chronic Aortic Dissection",[81,82,83,84,85],"Complex aortic repair","Aortic aneurysm","Aortic dissection","Fenestrated\u002Fbranched endograft","Custom-made endovascular graft","2026-06-03",{"date":88,"type":34},"2026-06-04",{"date":90,"type":34},"2023-05-31",{"date":92,"type":21},"2030-12",{"name":94,"class":95},"Cook Research Incorporated","INDUSTRY",{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":103,"targetDuration":105,"studyType":75,"phases":4,"briefSummary":106,"conditions":107,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":118},"100604288","tambe-japan-post-marketing-surveillance-100604288","NCT07147569","TAMBE Japan Post-Marketing Surveillance","GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis Post-Marketing Surveillance","Inclusion Criteria:\n\n* Patients who were attempted to implant the AC\n* Thoracoabdominal aortic aneurysm\n* Pararenal abdominal aortic aneurysm\n\nExclusion Criteria:\n\n* N\u002FA",{"count":104,"type":21},100,"60 Months","To evaluate the safety and efficacy of multi component system (TAMBE device) including GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (Aortic Component; AC) under post-marketing use.",[27,108],"Pararenal Aortic Aneurysm","2026-05-04",{"date":111,"type":34},"2026-05-05",{"date":113,"type":34},"2026-03-27",{"date":115,"type":21},"2034-02-28",{"name":117,"class":95},"W.L.Gore & Associates",5,{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":4,"eligibilityCriteria":125,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":22,"phases":128,"briefSummary":129,"conditions":130,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":42},"100465311","physician-modified-endograft-for-complex-aortic-aneurysm-repair-100465311","NCT05339061","Physician Modified Endograft For Complex Aortic Aneurysm Repair","A Single-Arm, Single-Center, Non-Randomized, Prospective Clinical Study to Evaluate the Safety and Effectiveness of Physician Modified Endograft for Complex Abdominal and Thoracoabdominal Aortic Aneurysm Repair","---Inclusion criteria---\n\n1. Patient is \\> 18 years of age\n2. Patients who are male or non-pregnant female (females of child bearing potential must have a negative pregnancy test prior to enrollment into the study)\n3. Patient is able and willing to sign an Institutional Review Board (IRB) approved Informed Consent Form\n4. Patient has a complex, juxtarenal, pararenal or thoracoabdominal abdominal aortic aneurysm (Extent I-V) that meets at least one of the following:\n\n   * Aortic aneurysm with diameter ≥ 5.5cm\n   * Aortic aneurysm with a history of growth ≥0.5cm in the last 6 months\n   * Symptomatic aortic aneurysm\n5. Cannot be treated with a currently available non-modified approved device\n6. High risk for open surgical repair based on any of the factors below:\n\n   1. Anatomic i. Previous abdominal surgery ii. Previous left-sided thoracotomy (if the proposed open repair would require dissection of the thoracic aorta) iii. Previous aortic surgery\n   2. Physiologic i. ASA Category III or higher ii. Age \\>70 years iii. Previous myocardial infarction, coronary artery disease, or coronary artery stent iv. Coronary stress test with a reversible perfusion defect v. Congestive heart failure vi. COPD\n7. Patient has patent iliac or femoral arteries that will allow endovascular access with the physician modified endovascular graft or is suitable for an iliac conduit\n8. Patient has a suitable non-aneurysmal proximal aortic neck length (seal zone) of ≥ 20 mm\n9. Patient has a suitable non-aneurysmal distal iliac artery length (seal zone) of ≥ 15 mm.\n10. The resultant repair should preserve patency in at least one hypogastric artery.\n11. Patient has a suitable non-aneurysmal proximal aortic neck diameter between 15 and 42mm\n12. Patient has suitable non-aneurysmal distal common iliac diameters between 7 and 20 mm.\n\n---Exclusion Criteria---\n\n-General Exclusion Criteria-\n\n1. Patient has a mycotic aneurysm\n2. Patient has a ruptured aneurysm requiring urgent or emergent repair\n3. Patient has a systemic or local infection that may increase the risk of graft infection\n4. Patient has a body habitus that would inhibit X-ray visualization of the aorta.\n5. Patient is willing and eligible to participate in a manufacturer-sponsored clinical study at another institution\n6. Patient has a major surgical or interventional procedure planned within +\u002F- 30 days of the (T)AAA repair.\n7. Patient is currently participating in another investigational device or drug clinical trial.\n\n-Medical Exclusion Criteria-\n\n1. Patient has a known hypersensitivity or contraindication to anticoagulation or contrast media that is not amenable to pre-treatment.\n2. Patient has a known allergy or intolerance to stainless steel, polyester, polypropylene, nickel, titanium or gold.\n3. Patient has uncorrectable coagulopathy\n4. Patient has unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina, or onset of prolonged angina)\n5. Patient has history of connective tissue disease (e.g., Marfan's or Ehler's-Danlos syndrome).\n6. Patient has active malignancy with life expectancy of less than 2 years\n7. Patient has a limited life expectancy of less than 2 years.\n8. Patient has other medical, social or psychological conditions that, in the opinion of the investigator, preclude them from receiving the pre-treatment, required treatment, and post-treatment procedures and evaluations.\n\n-Anatomic Exclusion Criteria-\n\n1. Significant occlusive disease, tortuosity or calcification that would prevent endovascular access\n2. Proximal seal site with a circumferential thrombus\u002Fatheroma\n3. Inability to maintain at least one patent hypogastric artery\n4. Shaggy aorta\n5. Patient is not amenable to a temporary or permanent open surgical or endovascular conduit",{"count":127,"type":21},40,[24],"The physician modified endograft is intended for treating complex, pararenal, juxtarenal and thoracoabdominal aortic aneurysms requiring coverage of renal arteries, the superior mesenteric artery or the celiac trunk in high-risk patients who do not have an option for endovascular repair with an FDA approved endograft and have an appropriate anatomy. There will be one investigational site with a total of 40 subjects to be enrolled. Time to complete enrollment will be 24 months and the subject follow-up time will be five years from last subject enrollment.\n\nThe primary safety endpoint is freedom from major adverse events (MAE) at 30 days or during hospitalization if this exceeds 30 days. The primary effectiveness endpoint is the proportion of study subjects with treatment success at one year. The subjects will be followed at one month, six months, one year, and yearly thereafter for a total period of five years. Subjects will be followed up clinically for life. Clinical exam follow up may be phone or video visit with CT scan evaluation and duplex ultrasound as needed. The proportion of treatment group subjects that achieve and maintain treatment success annually to five years will be investigated.",[78,131,108,27],"Juxtarenal Aortic Aneurysm","2026-05-01",{"date":134,"type":34},"2026-05-06",{"date":136,"type":34},"2023-03-01",{"date":138,"type":21},"2029-12",{"name":140,"class":41},"University of California, Davis",{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":148,"targetDuration":4,"studyType":22,"phases":149,"briefSummary":150,"conditions":151,"keywords":156,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":42},"100590616","evaluation-of-clinical-efficacy-and-safety-of-aortal-stent-graft-created-using-3d-printing-technology-100590616","NCT06969729","Evaluation of Clinical Efficacy and Safety of Aortal Stent-Graft Created Using 3D Printing Technology","Evaluation of Clinical Efficacy and Safety of Aortal Stent-graft Modelled Printing 3D Model Printing Technology - Multicenter, Randomized Clinical Trial","Inclusion Criteria:\n\nFemale and male subjects age ≥ 18 2. Subject need to meet one of the following criteria:\n\n* Subjects with juxtarenal or suprarenal abdominal aortic aneurysm, type IV thoracoabdominal aneurysm of diameter \\>5.5cm (male) and 5.2cm (female)\n* Subjects with juxtarenal or suprarenal abdominal aortic aneurysm, type IV thoraco-abdominal aneurysm with aneurysm growth rate ≥ 0.5cm during 6 months\n* Type IA endoleak of post-implantation of abdominal stent- graft 3. Iliac arteries morphology with aortic stent graft implantation to be restored 4. Aortic segment which is proximal to aneurysm\n* Length ≥20mm\n* Diameter 20mm-36mm\n* Aortic suprarenal angle ≤75 degrees 5. Survival \\> 2 years\n\nExclusion Criteria:\n\n1. Female and male subjects age \\\u003C18\n2. Pregnancy and breast feeding\n3. Allergy and hypersensitivity to matherials of which the stent- graft is composed\n4. Hypersensitivity and contraindication to anti coagulation or contrast application to angio - CT which cannot be eliminated medically\n5. Coagulopathy which cannot medically treated\n6. Active infection which might cause stent - graft infection\n7. Creatinine level \\> 3.0mg\u002FdL\n8. Marphan syndrome, Ehlers - Denlos syndrome\n9. Unstable angina pectoris\n10. Raptured aortic aneurysm caused by cardiac insufficiency\n11. Unwillingness to comply with protocol procedures\n12. Iliac arteries morphology adequate for stent-graft implantation\n13. The diameter of the aortic flow lumen in reno-visceral aorta greater than 34mm\n14. Aortic section which is proximal to celiac artery with significant number of thrombi, calcification or changed by aneurysm\n15. Aorta with significant number of irregular thrombi which may lead to embolism (\"shaggy aorta\")\n16. Diameter of proximal kidney arteries which is exercisable to stenting \\\u003C4.5mm\n17. Devision of kidney artery which is exercisable to stenting in the distance of \\\u003C1cm of celiac artery, each of them is is in \\\u003C4.5mm in diameter\n18. Atypical anatomy of celiac artery in the form of separate exit of splenic and hepatic aortic artery",{"count":104,"type":21},[24],"the comparison of physician-modified stent-graft created in 3D models versus custom-made devices in the treatment of complex abdominal aortic aneurysm",[152,153,154,27,155],"Abdominal Aortic Aneurysm","Juxtarenal Abdominal Aortic Aneurysm","Pararenal Abdominal Aortic Aneurysm","Type IA Endoleak",[157,158,159,160,161,162,163,164,165,166,167,168,169,170,171,172],"AAA","physician-modified stent-graft","custom-made device","complex abdominal aortic aneurysm","juxtarenal abdominal aortic aneurysm","pararenal abdominal aortic aneurysm","thoracoabdominal aortic aneurysm","endovascular aneurysm repair","3D printing","3D model","PMEG","type IA endoleak","aortic stent-graft","PMSG","patient-specific 3D model","complex aortic pathology","2026-04-13",{"date":175,"type":34},"2026-04-16",{"date":177,"type":34},"2022-11-01",{"date":179,"type":21},"2027-04-30",{"name":181,"class":41},"Samodzielny Publiczny Szpital Kliniczny nr 2 PUM",{"id":183,"slug":184,"hasResults":11,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":4,"eligibilityCriteria":188,"healthyVolunteers":11,"sex":17,"minAge":189,"maxAge":4,"enrollmentInfo":190,"targetDuration":4,"studyType":22,"phases":192,"briefSummary":193,"conditions":194,"keywords":196,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":42},"100419818","safety-and-efficacy-of-endovascular-repair-of-complex-aortic-pathology-with-physician-modified-endovascular-grafts-pmegs-100419818","NCT04746677","Safety and Efficacy of Endovascular Repair of Complex Aortic Pathology With Physician-modified Endovascular Grafts (PMEGs)","Single-Center Investigational Device Exemption Trial: Safety and Efficacy of Endovascular Repair of Complex Aortic Pathology With Physician-modified Endovascular Grafts (PMEGs)","INCLUSION CRITERIA:\n\nGeneral inclusion criteria (applicable to all 3 study arms):\n\n* Aortic pathology that fits one of the study arms (see below for detailed description)\n* Aortic pathology that cannot be treated within the Instructions for Use of an FDA- approved, commercially-available device\n* Aortic aneurysm that can be treated within the Instructions for Use of an FDA-approved, commercially-available custom-manufactured device but deemed unsafe to wait the required time for device manufacturing\n* Subject is at high-risk of morbidity and mortality with open surgical repair based on cardiopulmonary function, extent of comorbid disease, and anatomic complexity\n* Iliac and\u002For femoral access vessel morphology that is compatible with vascular access techniques, devices, or accessories, with or without use of a surgical or endovascular conduit\n* Non-aneurysmal aortic segment proximal to the aortic pathology with a:\n\n  * Minimum neck length of 20 mm\n  * Diameter between 20 - 42 mm\n* Non-aneurysmal aortic or iliac segment distal to the aortic pathology with:\n\n  * Aortic distal fixation site greater than 20 mm in length and diameter between 20-42 mm\n  * Iliac artery distal fixation site greater than 10 mm in length and diameter range 8- 25 mm\n* Age ≥21 years old\n* Life expectancy: ≥2 years\n\nArm1:\n\n* Complex abdominal aortic aneurysm, specifically juxtarenal or suprarenal abdominal aortic aneurysm or type IV thoracoabdominal aortic aneurysm, with maximum diameter of ≥5.5 cm for men or ≥5.0 cm for women, growth ≥0.5 cm in 6 months, or concomitant iliac aneurysm ≥3 cm\n* Prior endovascular aortic aneurysm repair with loss of proximal seal requiring incorporation of the renal arteries, SMA, and\u002For CA for repair, without aneurysmal disease extending above the diaphragmatic hiatus\n* Prior open abdominal aortic aneurysm repair with aneurysmal disease proximal to the repair requiring incorporation of the renal arteries, SMA, and\u002For CA for repair, without aneurysmal disease above the diaphragmatic hiatus\n* Saccular complex abdominal aortic aneurysm deemed at significant risk for rupture\n* Symptomatic complex aortic aneurysm\n* Penetrating aortic ulcer with depth ≥1 cm or width ≥2 cm, for which endovascular repair requires incorporation of the renal arteries, SMA, and\u002For CA, without involvement of the aorta above the diaphragmatic hiatus\n* Aortic pseudoaneurysm for which endovascular repair requires incorporation of the renal arteries, SMA, and\u002For CA, without involvement of the aorta above the diaphragmatic hiatus\n\nArm2:\n\n* Type I, II, or III thoracoabdominal aortic aneurysm with maximum diameter of ≥5.5 cm, or growth ≥0.5 cm in 6 months\n* Prior endovascular aortic aneurysm repair with loss of proximal seal requiring incorporation of the renal arteries, SMA, and\u002For CA for repair with aneurysmal disease extending above the diaphragmatic hiatus\n* Prior thoracic endovascular aneurysm repair with loss of distal seal requiring incorporation of the renal arteries, SMA, and\u002For CA for repair\n* Prior open abdominal aortic aneurysm repair with aneurysmal disease proximal to the repair requiring incorporation of the renal arteries, SMA, and\u002For CA for repair, with aneurysmal disease above the diaphragmatic hiatus\n* Saccular type I, II, or III thoracoabdominal aortic aneurysm deemed at significant risk for rupture\n* Symptomatic type I, II, or III thoracoabdominal aortic aneurysm\n* Penetrating aortic ulcer with depth ≥1 cm or width ≥2 cm, for which endovascular repair requires incorporation of the renal arteries, SMA, and\u002For CA, with involvement of the aorta above the diaphragmatic hiatus\n* Aortic pseudoaneurysm for which endovascular repair requires incorporation of the renal arteries, SMA, and\u002For CA, with involvement of the aorta above the diaphragmatic hiatus\n\nArm 3:\n\n* Acute or chronic type B aortic dissection with indication for repair including, but not limited to renal, mesenteric, or lower extremity malperfusion, progression of dissection, or persistence of symptoms despite optimal medical therapy\n* Prior repair of type A dissection and development of acute or chronic type B dissection component with indication for repair (listed above)\n* Aortic intramural hematoma (IMH) with indication for repair including, but not limited to renal, mesenteric, or lower extremity malperfusion, progression of dissection, or more typically, persistence of symptoms despite optimal medical therapy\n\nArm 4\n\n* Patient does not meet the inclusion\u002Fexclusion criteria of Arms 1 - 3\n* Patient has prohibitive operative risk for open repair and no other viable endovascular treatment option\n* Estimated perioperative risk is lower than the estimated 1-year mortality without surgery\n\nEXCLUSION CRITERIA:\n\nGeneral Exclusion Criteria\n\n* Subject is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site\n* Subject is unwilling to comply with the follow-up schedule\n* Inability or refusal to give informed consent by subject or legal representative\n* Subject is pregnant or breastfeeding\n* Subject has a ruptured aneurysm\n\nArm 5 • Patient meets criteria for Arms 1-4\n\n\\- Patient is undergoing repair using the TREO bifurcated stent graft\n\nIndications for using TREO bifurcated stent graft:\n\n* Patient has undergone a prior endovascular aortic repair and meets criteria for repair; OR\n* -Patient has measured length from the lowest renal artery to the aortic bifurcation (either de novo or from a prior endograft) \\\u003C 115 mm; OR\n\n  * In patients with notable vessel tortuosity, where centerline measurement may not accurately reflect the distance covered needed in situ; OR\n  * Additional clinical or anatomic scenarios where forthcoming experience may demonstrate the TREO endograft to be superior to the currently-used Alpha\u002FAlpha 2 endograft.\n\nMedical Exclusion Criteria\n\n* Known sensitivities or allergies to the materials of construction of the devices\n* Known hypersensitivity or contraindication to anticoagulation or contrast media that cannot be adequately medically managed\n* Uncorrectable coagulopathy\n* Body habitus that would inhibit x-ray visualization of the aorta or exceeds the safe capacity of the equipment\n* Systemic or local infection that may increase the risk of endovascular graft infection\n* Diagnosis of connective tissue disorders (e.g., Marfan Syndrome, Ehler's Danlos Syndrome)\n\nAnatomic Exclusion Criteria\n\n* Inability to perform open or endovascular iliac conduit in patients with inadequate femoral\u002Filiac access\n* Excessive thrombus or calcification within the neck of the aneurysm\n* Visceral vessel anatomy not compatible with placement of a physician-modified endovascular graft due to occlusive disease or small size","21 Years",{"count":191,"type":21},220,[24],"The primary objective of this study is to examine the safety and effectiveness of physician-modified endovascular grafts (PMEGs) for endovascular repair of complex aortic pathology in high-risk patients. The study is divided into three study arms based on the subject's aortic pathology: (1) Complex abdominal aortic aneurysm (AAA); (2) Thoracoabdominal aortic aneurysm; and (3) Aortic dissection.",[152,27,195],"Aortic Dissection",[197,198,199],"Fenestrated endovascular aortic repair","Branched endovascular aortic repair","Complex aortic aneurysm repair","2026-04-02",{"date":202,"type":34},"2026-04-08",{"date":204,"type":34},"2021-03-15",{"date":206,"type":21},"2031-03-31",{"name":208,"class":41},"Beth Israel Deaconess Medical Center",{"id":210,"slug":211,"hasResults":11,"nctId":212,"briefTitle":213,"officialTitle":213,"acronym":4,"eligibilityCriteria":214,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":215,"targetDuration":4,"studyType":22,"phases":217,"briefSummary":218,"conditions":219,"keywords":221,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":237},"100093930","endovascular-exclusion-of-thoracoabdominal-andor-paravisceral-abdominal-aortic-aneurysm-100093930","NCT00483249","Endovascular Exclusion of Thoracoabdominal and\u002For Paravisceral Abdominal Aortic Aneurysm","Inclusion Criteria\n\n1. Aortic aneurysms:\n\n   * greater than or equal to 6 cm in diameter in men,\n   * greater than or equal to 5.5 cm in diameter in women,\n   * and\u002For larger than 5 cm in diameter and enlarging at a rate of more than 5 mm\u002Fyear,\n   * and\u002For iliac aneurysms larger than 4 cm in diameter.\n2. Anticipated mortality comparable to published rates with conventional surgical treatment.\n3. Life expectancy more than 2 years.\n4. Ability to give informed consent.\n5. Willingness to comply with follow-up schedule.\n6. Suitable arterial anatomy for endovascular repair.\n\nExclusion Criteria\n\n1. Free rupture of the aneurysm.\n2. Pregnancy.\n3. Known allergy to Nitinol, stainless steel, or polyester.\n4. Unwillingness or inability to comply with the follow up schedule.\n5. Serious systemic or groin infection.\n6. Uncorrectable coagulopathy.",{"count":216,"type":21},250,[24],"This is a study to assess the safety and effectiveness of endovascular treatment of thoracoabdominal (TAAA) and paravisceral abdominal (PVAAA) aortic aneurysms. The investigational operation involves placing a stent-graft over the aortic aneurysm.",[27,220],"Paravisceral Abdominal Aortic Aneurysm",[222,223,224,225,226,227],"Thoracoabdominal","Paravisceral","Aneurysm","Endovascular","Stent-Graft","Aorta","2026-03-03",{"date":230,"type":34},"2026-03-05",{"date":232,"type":4},"2005-05",{"date":234,"type":21},"2027-12",{"name":236,"class":41},"Warren J. Gasper, MD",2,{"id":239,"slug":240,"hasResults":11,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":4,"eligibilityCriteria":244,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":245,"targetDuration":4,"studyType":22,"phases":247,"briefSummary":248,"conditions":249,"keywords":251,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":255,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":263},"100216042","caaas-taaas-aortic-arch-aneurysms-or-dissections-with-fenestratedbranched-stent-graft-100216042","NCT02089607","CAAAs, TAAAs, Aortic Arch Aneurysms or Dissections With Fenestrated\u002FBranched Stent Graft","Clinical Outcomes and Quality of Life Measures in Patients Treated for Complex Abdominal, Thoracoabdominal and Aortic Arch Aneurysms or Dissections With Fenestrated and Branched Stent Grafts","General Inclusion Criteria:\n\n* Thoracoabdominal aortic aneurysm with a diameter ≥ 5.5 cm or 2 times the normal aortic diameter.\n* Aneurysm with a history of growth ≥ 0.5 cm per year.\n* Saccular aneurysms deemed at significant risk for rupture based upon physician interpretation.\n* Presence of concomitant thoracoabdominal and aortic arch aneurysm meeting one of the above-mentioned criteria.\n* Presence of thoracoabdominal aortic aneurysm meeting one of the above-mentioned criteria with unilateral or bilateral common iliac artery aneurysm with diameter ≥ 3.0-cm or saccular morphology with no suitable landing zone proximal to iliac bifurcation.\n\nGeneral Exclusion Criteria:\n\n* Less than 18 years of age\n* Unwilling to comply with the follow-up schedule\n* Inability or refusal to give informed consent by the patient or a legally authorized representative\n* Pregnant or breastfeeding\n* Life expectancy \\\u003C 2 years\n* Prior open surgical or interventional procedure within 30 days of the anticipated date of the fenestrated-branched procedure, with the exception of planned staged procedures to provide access for repair (e.g. staged iliac conduit, cervical debranching, elephant trunk repair), to facilitate the procedure by allowing open revascularization of a target artery not amenable to revascularization with the investigational device, such as an internal iliac artery, subclavian artery or visceral artery with early bifurcation, tortuosity or occlusive disease preventing successful placement of alignment side stents.\n* Participation in another investigational clinical or device trial, with the exception of participation in another investigational endovascular stent-graft protocol, percutaneous aortic valve protocol, or concomitant clinical trials designed to evaluate medical therapy strategies to reduce perioperative risk during fenestrated-branched endovascular repair, including risks of renal dysfunction, contrast-induced nephropathy, neurologic, spinal cord or cardiac complications, and\u002For use of advanced imaging to reduce radiation exposure during implantation of these devices. Participation in investigational device trials not encompassed by the IDE protocol should be performed remotely from the fenestrated procedure (\\> 30 days). Examples include remote (\\>30 days) participation in a thoracic, abdominal or iliac branch device trial, or participation in a percutaneous aortic valve trial. Participation in medical therapy trial or advanced imaging trial designed to improve peri-operative outcomes or to reduce radiation exposure of fenestrated-branched endografts may be concurrent with the IDE study. Examples include therapy directed to reduce rates of spinal cord injury, stroke and contrast-induced nephropathy associated with implantation of fenestrated-branched stent-grafts or advanced imaging trials designed to reduce radiation exposure during repair.\n* Patients with ruptured aortic aneurysms requiring urgent or emergent repair, with the exception of patients with contained, stable ruptures with anatomy suitable for an off-the-shelf design.\n\nMedical Exclusion Criteria:\n\n* Known sensitivities or allergies to stainless steel, nitinol, polyester, solder (tin, silver), polypropylene, PTFE, urethane or gold\n* History of anaphylactic reaction to contrast material that cannot be adequately pre-medicated\n* Leaking or ruptured aneurysm associated with hypotension\n* Uncorrectable coagulopathy\n* Mycotic aneurysm or patients with evidence of active systemic infection.\n* History of connective tissue disorder (e.g vascular Ehlers Danlos, Marfans syndrome), with the exception of those patients who had prior open surgical aortic replacement, where a surgical graft would serve as landing zone for the investigational stent-graft, those who are deemed prohibitive risk for open surgical repair or connective tissue disorders with no effect of vascular system (e.g non-vascular forms of Ehlers Danlos).\n* Body habitus that would inhibit X-ray visualization of the aorta and its branches.\n\nAnatomical Exclusion Criteria:\n\n* Inadequate femoral or iliac access compatible with the required delivery systems.\n* Inability to perform a temporary or permanent open surgical or endovascular iliac conduit for patients with inadequate femoral\u002Filiac access.\n* Absence of a non-aneurysmal aortic segment in the distal thoracic aorta above the diaphragmatic hiatus with: a. A diameter measured outer wall to outer wall of no greater than 42mm and no less than 21 mm; b. Parallel aortic wall with \\\u003C20% diameter change and without significant calcification and\u002For thrombus in the selected area of seal zone\n* Visceral vessel anatomy not compatible with Zenith t-Branch or patient-specific stent-graft due to excessive occlusive disease or small size not amenable to stent graft placement\n* Unsuitable distal iliac artery fixation site and anatomy for iliac limb extension or iliac branch device: a. Common iliac artery fixation site diameter, measured outer wall to outer wall on a sectional image (CT) \\\u003C8.0 mm with inability to perform open surgical conduit ; b. Iliac artery diameter, measured outer wall to outer wall on a sectional image (CT) \\>20 mm at distal fixation site, with inability to perform open internal iliac artery revascularization or iliac branch stent graft ; c. Non-aneurysmal external liac artery distal fixation site \\\u003C10 mm in length ; d. Non-aneurysmal internal iliac artery main trunk or branch segment with length \\\u003C10mm or with inner wall diameter \\\u003C4 or \\>14mm; e. Unsuitable anatomy due to inability to preserve at least one hypogastric artery\n\nAdditional anatomical inclusion criteria for aortic arch devices:\n\n* Proximal aortic fixation zone: a. Native aorta or surgical graft; b. Diameter: 20-42mm; c. Proximal neck length ≥ 20mm; d. Ascending aortic length ≥50mm; e. Must occur distal to coronary arteries and any coronary artery bypass grafts that are considered patent and necessary for proper cardiac perfusion\n* Distal aortic fixation zone:; a. Native aorta or surgical graft; b. Diameter: 20-42mm; c. Distal neck length ≥20mm\n* Supra-aortic trunk (brachiocephalic) vessels: a. Although the prosthesis will typically have two branches, modifications to the design will allow for a single branch, three branches or combination of branch and scallop if a customized version is required. Thus, it is generally planned that at least one extra-anatomic bypass graft will be done in conjunction (or in a staged fashion) with the procedure, unless three branches are planned. The two vessels incorporated into the endograft repair would most commonly be the innominate artery and left common carotid artery. However, the innominate artery may be coupled with the left subclavian artery in the setting of a bovine arch whereby the flow to the left carotid would come from a left subclavian to carotid bypass. Similarly, the left carotid and subclavian artery may be branched, or simply one vessel branched should specific anatomic limitations exist. In such a situation, multiple extra-anatomic bypasses may be necessary. A design with a single subclavian retrograde branch and double scallop to the left carotid artery may be used to extent the landing zone to Zone 1. Finally, a design with two antegrade inner branches for the innominate and left common carotid, and one retrograde inner branch for the left subclavian artery may be used in select cases. Thus the inclusion criteria are defined for each artery, yet any combination of arteries may be used for a repair: Innominate artery (Native vessel or surgical graft, Diameter: 8-22mm, Length of sealing zone ≥10mm, Acceptable tortuosity); Left (or right) common carotid artery (Native vessel or surgical graft, Diameter 6-16mm, Length of sealing zone ≥10mm, Acceptable tortuosity); Left (or right) common carotid artery (Native vessel or surgical graft, Diameter: 5-20mm, Length of sealing zone ≥10mm, Acceptable tortuosity).\n* In the setting of an aortic dissection the following criteria must exist: a. Access into the true lumen from the groin and at least one supra-aortic trunk vessel; b. A sealing zone in the target aorta (or surgical graft) that is proximal to the primary dissection, such that a stent-graft would be anticipated to seal off the dissection lumen; c. A sealing zone in the target supra-aortic trunk vessels that is distal to the dissection, anticipated to seal off the dissection lumen, or surgically created; d. A true lumen size large enough to deploy the device and still gain access into the target branches\n* In the setting of more distal disease: a. The repair may be coupled with a thoracoabdominal branched device, infrarenal device, and\u002For internal iliac branch device.\n* Iliac anatomy must allow for the delivery of the arch branch device which is loaded within a 20F-24F sheath. Thus the iliac requirements are no different than the standard thoracic protocol. Conduits to the iliac vessels or aorta may be used if deemed necessary.",{"count":246,"type":21},760,[24],"The purpose of this study is to gather safety and effectiveness of the Zenith t-Branch and customized physician-specified stent-graft with a combination of fenestrations and\u002For branches to repair aortic aneurysm.",[78,27,54,250],"Aortic Arch Dissection",[252,253],"aneurysm","aortic aneurysm","2026-01-16",{"date":256,"type":34},"2026-01-20",{"date":258,"type":34},"2014-03",{"date":260,"type":21},"2032-05",{"name":262,"class":41},"Baylor College of Medicine",3,{"id":265,"slug":266,"hasResults":11,"nctId":267,"briefTitle":268,"officialTitle":269,"acronym":4,"eligibilityCriteria":270,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":271,"targetDuration":4,"studyType":22,"phases":273,"briefSummary":274,"conditions":275,"keywords":278,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":301,"locationsCount":42},"100212530","evaluation-of-the-cook-custom-aortic-endograft-the-zenith-t-branch-endovascular-graft-and-surgeon-modified-endograft-in-treating-aortic-pathologies-100212530","NCT02043691","Evaluation of the Cook Custom Aortic Endograft, the Zenith t-Branch Endovascular Graft, and Surgeon-Modified Endograft in Treating Aortic Pathologies","Evaluation of All-Cause Mortality and Pulmonary Morbidity in Treating Juxtarenal, Suprarenal, Thoracoabdominal, and Aortic Arch Pathologies Using Cook Custom Aortic Endografts, the Zenith t-Branch Endovascular Graft, and the Surgeon-Modified Endograft","Inclusion Criteria:\n\n* Juxtarenal, suprarenal, and thoracoabdominal aortic pathology as follows in hemodynamically stable patients:\n\n  1. Intact or contained ruptured aortic or aortoiliac aneurysms (atherosclerotic\u002Fdegenerative or saccular) involving or in close approximation to the visceral segment of the aorta.\n\n     1. Diameter \\> 5.5 cm if asymptomatic, or 5.0 cm with enlargement of \\> 0.5 cm in 6 months.\n     2. History of growth \\> 0.5 cm per year\n     3. Any size if ruptured or symptomatic\n  2. Penetrating aortic ulcer (PAU)\n\n     1. \\> 2.0 cm in depth\n     2. Any size if contained ruptured or symptomatic\n  3. Subacute (\\>14 days) or chronic (\\>20 days) aortic dissection with aneurysmal degeneration with at least one of the following:\n\n     1. Total aortic diameter \\> 5.5 cm if asymptomatic\n     2. Total aortic diameter \\> 4.5 cm if symptomatic\n     3. Total aortic diameter \\> 5.0 cm and history of growth \\> 0.5 cm in 6 months\n* Aortic Arch pathology:\n\n  1. Aneurysm, Ascending thoracic aortic pseudoaneurysm, Type A thoracic aortic dissection, Retrograde type A thoracic aortic dissection between the Sinus of Valsalva and the innominate artery orifice (without involvement of the Aortic Valve), or Ascending penetrating aortic ulcer with and without intramural hematoma\n  2. Suitable iliac artery and brachial artery access\n  3. Absence of severe landing zone (\\> 90 degree) angulation that would preclude necessary device delivery\u002Fseal\u002Ffixation.\n  4. Suitable iliac artery access to accommodate device delivery system.\n  5. Target arteries for arch branches:\n\n     1. \\\u003C 24 mm diameter\n     2. Adequate landing zone length to obtain proximal and distal seal.\n     3. Free from dissection precluding adequate seal in distal landing zone of branch stent and severe tortuosity\u002Fthrombus\u002Fcalcification.\n* Aortic Arch Aneurysm\n\n  1. Proximal aortic fixation zone:\n\n     1. Native aorta or surgical graft\n     2. Diameter: 20 - 42 mm\n  2. Proximal neck length \\> 20 mm\n  3. Must occur distal to coronary arteries and any coronary artery bypass grafts that are considered patent and necessary for proper cardiac perfusion.\n  4. Distal aortic fixation zone:\n\n     1. Native aorta or surgical graft\n     2. Diameter: 20 - 44 mm\n  5. Distal neck length \\> 20 mm. However, if dissection, distal graft may land in dissected aorta.\n  6. Supra-aortic trunk (brachiocephalic) vessels (Any combination of arteries may be used for repair) A. Innominate artery\n\n     1. Native vessel or surgical graft\n     2. Diameter: 8 - 22 mm\n     3. Length of sealing zone \\> 10 mm\n     4. Acceptable tortuosity B. Left (or right) common carotid artery\n\n     \u003C!-- -->\n\n     1. Native vessel or surgical graft\n     2. Diameter 5 - 20 mm\n     3. Length of sealing zone \\> 10 mm C. Left (or right) subclavian artery\n\n     \u003C!-- -->\n\n     1. Native vessel or surgical graft\n     2. Diameter 5 - 20 mm\n     3. Length of sealing zone \\> 10 mm\n* Aortic Dissection\n\n  1. Access into the true lumen from the groin and at least one supra-aortic trunk vessel.\n  2. Seal zone in the target aorta (or surgical graft) that is proximal to the primary dissection, such that a stent-graft would be anticipated to seal off the dissection lumen.\n  3. Seal zone in the target supra-aortic trunk vessels that is distal to the dissection, anticipated to seal off the dissection lumen or surgically created.\n  4. True lumen size large enough to deploy the device and still gain access into the target branch.\n\nGeneral Exclusion Criteria:\n\n* Less than 18 years of age\n* Life expectancy less than 12 months based on the surgeon's assessment\n* Pregnant or breastfeeding or planning on becoming pregnant within 60 months\n* Inability or refusal to give informed consent\n* Unwilling or unable to comply with the follow-up schedule\n* Less than 30 days beyond primary endpoint for other investigative drug or device study\n\nMedical Exclusion Criteria:\n\n* Known allergy to the device components (i.e. stainless steel, polyester, solder, gold, or nitinol)\n* History of anaphylactic reaction to contrast material that cannot be adequately premedicated\n* Systemic or local infection that may increase the risk of endovascular graft infection.\n* Baseline eGFR \\\u003C 30 mL\u002Fmin (calculated by the Modification of Diet in Renal Disease formula) and not on hemo- or peritoneal dialysis. If the patient is currently on dialysis, or is currently planning on initiating dialysis, then they may undergo repair.\n* Body habitus that would inhibit X-ray visualization of the aorta.\n* Major surgical or interventional procedure unrelated to the treatment of the aneurysm planned ≤ 30 days of the endovascular repair.\n* Unstable angina, defined as a progressive increase in symptoms, new onset at rest or nocturnal angina, or onset of prolonged angina.\n* Irreversible coagulopathy\n\nAnatomical Exclusion Criteria:\n\n* Aortic transection due to acute trauma.\n* Infectious (\"mycotic\") etiology of the aortic disease.\n* Significant occlusive disease or tortuosity precluding delivery of the device components.\n* Juxtarenal, Suprarenal, and Thoracoabdominal:\n* Proximal Landing zone \\\u003C 20 mm in length. The proximal landing zone can be within zones 2 through 8, with least 20 mm of proximal seal and fixation in aorta or Dacron.\n* Proximal neck, defined as the thoracic aorta distal to the native left carotid artery, measured outer wall to outer wall on a sectional image (CT) \\> 41 mm in diameter or \\\u003C 18 mm in diameter\n* Distal landing zone \\\u003C 20 mm in length if the landing zone is in the aorta, or \\\u003C 20 mm if the landing zone is in the iliac arteries or in Dacron (in the event the patient has had a previous or concomitant aortic or aorto-iliac reconstruction).\n* Untreatable branch vessel stenosis.\n* Anatomy that would not allow maintenance of at least one patent hypogastric artery.\n* Signs that the inferior mesenteric artery (IMA) is indispensable (i.e. angiographic visualization or a large IMA, filling of superior mesenteric artery (SMA) via collaterals, stenosis of celiac or SMA or oblique views) and the indispensable IMA is not amenable to treatment with a graft branch or fenestration.\n* Branching, duplication, aneurysm or untreatable stenosis of the celiac, SMA or renal arteries that would preclude implantation of the investigational devices.\n* Aortic arch:\n* Proximal neck \\> 44 mm or \\\u003C 28 mm in diameter\n* Inadequate landing zone to allow adequate distal seal of exclusion of false lumen perfusion in dissection.\n* Untreatable branch vessel stenosis.\n* Significant occlusive disease, tortuosity, or calcification that would prevent endovascular access.\n* Patients qualifying for an industry-sponsored study allowing for a similar repair will be enrolled in the industry-sponsored study.",{"count":272,"type":21},410,[24],"This is a single-center study to evaluate the safety and effectiveness of three investigational devices, the Cook Custom Aortic Endograft, the Zenith t-Branch Endovascular Graft, and the Surgeon-Modified Endografts in the treatment of Juxtarenal, Suprarenal, Thoracoabdominal, and Aortic Arch pathologies involving the at least one brachiocephalic artery or visceral vessels.\n\nThe three investigational devices offer an endovascular approach to treat complex aortic pathologies that cannot be treated with commercially available devices. This customized, endovascular approach has the potential to decrease hospital length of stay, pulmonary complications, and in-hospital mortality.",[131,276,27,277,54,195],"Suprarenal Aortic Aneurysm","Penetrating Aortic Ulcer",[225,279,224,222,280,281,282,283,284,285,286,287,288,289,290,291,292,293],"Aortic","Juxtarenal","Suprarenal","Endograft","Fenestrated","Branched","Complex","Abdominal","Thoracic","Stent","Stentgraft","Arch","Ascending","Dissection","Descending","2026-01-02",{"date":296,"type":34},"2026-01-06",{"date":298,"type":34},"2014-06",{"date":300,"type":21},"2027-10",{"name":302,"class":41},"University of Alabama at Birmingham",{"id":304,"slug":305,"hasResults":11,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":4,"eligibilityCriteria":309,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":310,"targetDuration":4,"studyType":22,"phases":312,"briefSummary":313,"conditions":314,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":317,"startDateStruct":319,"completionDateStruct":321,"leadSponsor":323,"locationsCount":42},"100556559","clinical-outcomes-and-major-adverse-events-in-patients-treated-with-physician-modified-fenestrated-and-branched-stent-grafts-100556559","NCT06526676","Clinical Outcomes and Major Adverse Events in Patients Treated With Physician-Modified Fenestrated and Branched Stent Grafts","Clinical Outcomes and Predictors of Major Adverse Events in Patients Treated for Juxtarenal, Pararenal and Thoracoabdominal Aortic Aneurysms With Physician-Modified Fenestrated and Branched Stent Grafts","Inclusion Criteria:\n\nA patient may be included in the study if at least one of the following is present and is considered appropriate for treatment with a physician modified stent graft. Patients must be deemed high risk for traditional open surgical repair, if any of the following conditions are present.\n\nPatients will be deemed physiologically high risk if any of the following conditions are present:\n\n* Older than 75 years of age\n* Chronic obstructive pulmonary disease\n* Congestive heart failure\n* Previous myocardial infarction, coronary stent, or bypass\n* Chronic renal insufficiency with baseline eGFR \\\u003C 40 ml\u002Fmin\n* American Society of Anesthesiologist (ASA) score \\> 3\n\nPatient will be deemed anatomically high risk if any of the following conditions are present:\n\n* Prior intraabdominal operation(s)\n* Prior abdominal wall reconstructions. (ie. Ventral hernia repairs)\n* Prior radiation therapy targeting abdomen and\u002For pelvis\n* History of intraabdominal sepsis. (ie. Diverticulitis managed with percutaneous drainage)\n\nPatients will then be included in one of three arms with the inclusion criteria specified as follows:\n\n* Arm 1 (Short neck infrarenal, juxtarenal, suprarenal and extent IV TAA)\n\n  * Juxtarenal, pararenal, suprarenal or extent IV thoracoabdominal aortic aneurysm or dissection with a diameter ≥ 5.5 cm or 2 times the normal aortic diameter.\n  * Juxtarenal, pararenal, suprarenal or extent IV thoracoabdominal aneurysm with a history of growth ≥ 0.5 cm in one year.\n  * Juxtarenal, pararenal, suprarenal or extent IV thoracoabdominal saccular aneurysms deemed at significant risk for rupture based upon physician interpretation.\n  * Presence of juxtarenal, pararenal, suprarenal or extent IV thoracoabdominal aortic aneurysm not meeting one of the above-mentioned criteria with or without unilateral or bilateral common iliac artery aneurysm with diameter ≥ 3.5-cm or saccular morphology with no suitable landing zone proximal to iliac bifurcation.\n* Arm 2 (Thoracoabdominal aortic aneurysms)\n\n  * Extent I, II, or III thoracoabdominal aortic aneurysm or dissection with a diameter ≥ 5.5 cm or 2 times the normal aortic diameter.\n  * Extent I, II, or III thoracoabdominal aortic aneurysm with a history of growth ≥ 0.5 cm in one year.\n  * Extent I, II, or III thoracoabdominal saccular aortic aneurysms deemed at significant risk for rupture based upon physician interpretation.\n  * Presence of Extent I, II, or III thoracoabdominal aortic aneurysm not meeting one of the above-mentioned criteria with or without unilateral or bilateral common iliac artery aneurysm with diameter ≥ 3.5-cm or saccular morphology with no suitable landing zone proximal to iliac bifurcation.\n* Arm 3 (Urgent or emergent aneurysms) o Ruptured, contained ruptured or symptomatic juxtarenal, pararenal, suprarenal or thoracoabdominal aortic aneurysm planned to receive urgent or emergent repair within 48 hours of clinical encounter, in patients able to provide informed consent and deemed not a reasonable candidate for open surgery or repair with any commercially available device.\n\nExclusion Criteria:\n\nPatients must be excluded from the study if any of the following conditions are true:\n\n* Less than 18 years of age\n* Unwilling to comply with the follow-up schedule\n* Inability or refusal to give informed consent by the patient or a legally authorized representative\n* Pregnant or breastfeeding\n* Life expectancy \\\u003C 2-years\n* Prior open surgical or interventional procedure within 30 days of the anticipated date of the fenestrated-branched procedure, with the exception of planned staged procedures to provide access for repair (e.g. staged iliac conduit, cervical debranching, elephant trunk repair), to facilitate the procedure by allowing open revascularization of a target artery not amenable to revascularization with the investigational device, such as an internal iliac artery, subclavian artery or visceral artery with early bifurcation, tortuosity or occlusive disease preventing successful placement of alignment side stents.\n* Patients eligible for treatment with any FDA-approved marketed device within its instructions for use\n* Can enroll in a manufacturer-sponsored clinical study at our institution or is willing and eligible to participate in a study with a manufactured-made device at another institution\n* Participation in another investigational clinical or device trial, with the exception of participation in another investigational endovascular stent-graft protocol, percutaneous aortic valve protocol, or concomitant clinical trials designed to evaluate medical therapy strategies to reduce perioperative risk during fenestrated-branched endovascular repair, including risks of renal dysfunction, contrast-induced nephropathy, neurologic, spinal cord or cardiac complications, and\u002For use of advanced imaging to reduce radiation exposure during implantation of these devices. Participation in investigational device trials not encompassed by the IDE protocol should be performed remotely from the fenestrated procedure (\\>30 days). Examples include remote (\\>30 days) participation in a thoracic, abdominal, or iliac branch device trial, or participation in a percutaneous aortic valve trial. Participation in medical therapy trial or advanced imaging trial designed to improve peri-operative outcomes or to reduce radiation exposure of fenestrated-branched endografts may be concurrent with the IDE study. Examples include therapy directed to reduce rates of spinal cord injury, stroke and contrast-induced nephropathy associated with implantation of fenestrated-branched stent-grafts or advanced imaging trials designed to reduce radiation exposure during repair.\n\nMedical Exclusion Criteria:\n\n* Known sensitivities or allergies to stainless steel, nitinol, polyester, solder (tin, silver), polypropylene, PTFE, urethane, or gold.\n* History of anaphylactic reaction to contrast material that cannot be adequately pre-medicated.\n* Uncorrectable coagulopathy.\n* Mycotic aneurysm or patients with evidence of active systemic infection.\n* History of connective tissue disorder (e.g vascular Ehlers Danlos, Marfan's syndrome), except for those patients who had prior open surgical aortic replacement, where a surgical graft would serve as landing zone for the investigational stent-graft, those who are deemed prohibitive risk for open surgical repair or connective tissue disorders with no effect of vascular system (e.g non-vascular Ehlers Danlos).\n* Body habitus that would inhibit X-ray visualization of the aorta and its branches.\n\nAnatomic Exclusion Criteria\n\n* Inadequate femoral or iliac access compatible with the required delivery systems.\n* Inability to perform a temporary or permanent open surgical or endovascular iliac conduit for patients with inadequate femoral\u002Filiac access.\n* Absence of a non-aneurysmal aortic segment in the distal thoracic aorta above the diaphragmatic hiatus with:\n\n  * A diameter measured outer wall to outer wall of no greater than 42mm and no less than 21 mm;\n  * Parallel aortic wall with \\\u003C20% diameter change and without significant calcification and\u002For thrombus in the selected area of seal zone\n* Visceral vessel anatomy not compatible with fenestrated\u002Fbranched stent graft visceral vessel incorporation due to excessive occlusive disease or small size not amenable to stent graft placement\n* Unsuitable distal iliac artery fixation site and anatomy for iliac limb extension or iliac branch device as per devices' instructions for use (IFU)",{"count":311,"type":21},50,[24],"The purpose of this study is to evaluate safety and effectiveness of endovascular treatment of juxtarenal, pararenal and thoracoabdominal aortic aneurysms (with or without iliac artery involvement) using physician-modified stent grafts with a combination of fenestrations and\u002For branches.",[131,315,27],"Pararenal Aneurysm","2025-12-09",{"date":318,"type":34},"2025-12-15",{"date":320,"type":34},"2025-12-02",{"date":322,"type":21},"2032-12",{"name":324,"class":41},"University of California, Los Angeles",{"id":326,"slug":327,"hasResults":11,"nctId":328,"briefTitle":329,"officialTitle":330,"acronym":331,"eligibilityCriteria":332,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":333,"enrollmentInfo":334,"targetDuration":4,"studyType":22,"phases":336,"briefSummary":338,"conditions":339,"keywords":342,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":354,"locationsCount":42},"100408562","phase-2-ketamine-in-patients-undergoing-tevar-procedures-receiving-nci-100408562","NCT04600089","Ketamine in Patients Undergoing TEVAR Procedures Receiving NCI","A Randomized, Double-blind, Placebo-controlled, Study to Identify the Opioid-sparing Effects, and Pain-reduction Potential of Low Dose Ketamine on Patients Undergoing TEVAR Procedures Receiving NCI","2020Ketamine","Inclusion Criteria:\n\n* willing to give informed consent\n* scheduled for elective thoracic aorta repair or thoracoabdominal aortic repair\n* requires naloxone continuous infusion for spinal prophylaxis\n\nExclusion Criteria:\n\n* allergy to ketamine, acetaminophen, or fentanyl\n* diagnosis of schizophrenia\n* history of hydrocephalus or central nervous system mass\n* incarcerated individuals\n* pregnant or lactating individuals","90 Years",{"count":335,"type":21},30,[337],"PHASE2","The objective of this study is to identify the opioid-sparing effects, and pain-reduction potential of low dose, sub-dissociative ketamine on patients undergoing thoracic endovascular aortic repair (TEVAR) procedures receiving naloxone continuous infusion (NCI).",[340,341,27],"Descending Aortic Dissection","Postoperative Pain",[343,344,345,346],"naloxone","ketamine","aortic repair","spinal cord ischemia","2025-10-15",{"date":349,"type":34},"2025-10-20",{"date":351,"type":34},"2020-12-08",{"date":353,"type":21},"2027-08",{"name":355,"class":41},"Sam Tyagi",{"id":357,"slug":358,"hasResults":11,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":362,"eligibilityCriteria":363,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":364,"enrollmentInfo":365,"targetDuration":4,"studyType":22,"phases":367,"briefSummary":369,"conditions":370,"keywords":373,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":378,"lastUpdatePostDateStruct":379,"startDateStruct":381,"completionDateStruct":383,"leadSponsor":385,"locationsCount":387},"100603802","phase-1-clinical-trial-of-bao-g-technique-in-complex-aortic-aneurysm-endovascular-repair-bao-g-02-100603802","NCT07141251","Clinical Trial of BAO-G Technique in Complex Aortic Aneurysm Endovascular Repair (BAO-G-02)","Multicenter, Open-labeled, Single-arm Clinical Trial of Multi-Branch AOrtic Reconstruction of Complex Aortic Aneurysm With G-iliac System [BAO-G] Technique","BAO-G-02","Inclusion Criteria:\n\n1. Diagnosed with Crawford type III-IV thoracoabdominal aortic aneurysm or complex abdominal aortic aneurysm, with a healthy proximal landing zone (\\>20mm length, angulation \\\u003C60°) in the descending aorta and maximum aneurysm diameter ≥4cm\n2. Scheduled for endovascular aortic repair with commercially available iliac branch devices for visceral artery reconstruction\n3. Signed informed consent and committed to protocol-defined follow-up\n\nExclusion Criteria:\n\n1. Acquired language barrier, intellectual decline, cognitive impairment, or mental illness preventing informed consent\n2. Uncontrolled autoimmune diseases (e.g., Takayasu arteritis, systemic lupus erythematosus, vasculitis)\n3. Prior aortic surgery with stent-graft or prosthetic vascular graft implantation\n4. End-stage renal\u002Fhepatic\u002Fcardiac\u002Fpulmonary failure or malignancy diagnosed within 5 years, likely to cause mortality during follow-up\n5. Active bleeding or coagulopathy within 6 months (high bleeding risk)\n6. Uncontrolled hypertension (resting SBP \\>180 mmHg or DBP \\>110 mmHg)\n7. Uncontrolled diabetes (fasting blood glucose \\>16.7 mmol\u002FL)\n8. Severe hepatic\u002Frenal dysfunction (serum creatinine \\>3 mg\u002FdL, ALT\u002FAST \\>3×ULN)\n9. Concurrent participation in other interventional clinical trials\n10. Pregnancy or perinatal status\n11. Refusal to sign informed consent","80 Years",{"count":366,"type":21},60,[368],"PHASE1","Multi-Branch AOrtic Reconstruction With G-iliac System (BAO-G) Technique is a novel technique of endovascular repair of complex aortic aneurysm, which using off-the-shelf iliac branched devices to reconstruct the visceral branches. This study aims to verify the perioperative safety and 5-year efficacy of BAO-G technique in the endovascular treatment of complex aortic aneurysms through a prospective, multicenter, open-label, single-arm clinical trial, and to provide evidence for the selection of clinical procedures for complex aortic aneurysm patients in the future.",[27,371,372],"Endovascular Repair","Complex Aortic Aneurysms",[374,375,376,377],"BAO-G technique","iliac-branched devices","endovascular repair","complex aortic aneurysm","2025-08-30",{"date":380,"type":34},"2025-09-05",{"date":382,"type":34},"2022-01-01",{"date":384,"type":21},"2035-12-31",{"name":386,"class":41},"Peking Union Medical College Hospital",11,{"id":389,"slug":390,"hasResults":11,"nctId":391,"briefTitle":392,"officialTitle":393,"acronym":4,"eligibilityCriteria":394,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":395,"targetDuration":4,"studyType":22,"phases":396,"briefSummary":397,"conditions":398,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":399,"lastUpdatePostDateStruct":400,"startDateStruct":402,"completionDateStruct":404,"leadSponsor":406,"locationsCount":237},"100454312","pmeg-for-repair-of-pararenal-and-thoracoabdominal-aortic-aneurysm-100454312","NCT05195905","PMEG for Repair of Pararenal and Thoracoabdominal Aortic Aneurysm","Evaluation of Spinal Cord Ischemia and Mortality and Morbidity After Endovascular Repair of Pararenal and Thoracoabdominal Aortic Aneurysm Using Surgeon-Modified Endografts","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Male or female, aged ≥18 years\n3. Expected survival beyond 1 year following successful aneurysm repair\n4. Anatomy that would require coverage of the celiac artery, superior mesenteric artery (SMA), and\u002For renal arteries if conventional, FDA-approved endograft were implanted to obtain adequate sealing zone length\n5. Aneurysm of the thoracoabdominal or pararenal aorta with or without chronic dissection\n6. Adequate proximal zone of fixation\n7. Adequate distal zone of fixation\n8. No more than 5 non-aneurysmal visceral (celiac, SMA, or renal) arteries with diameters between 4-12mm\n9. Adequate arterial access for delivery system; use of iliac conduit is permitted as necessary\n\nExclusion Criteria:\n\n1. Moderate-to-severe aortic neck calcification, thrombus, or tortuosity\n2. Severe iliac stenosis, calcification, or tortuosity with no ability to perform a conduit\n3. Proximal landing within zone 0 or 1\n4. Inability to maintain at least one patent hypogastric artery\n5. Freely ruptured aneurysm with hemodynamic instability\n6. Non-ambulatory status\n7. Severe CHF\n8. Baseline eGFR \\\u003C 30ml\u002Fmin, unless currently on or to be initiating dialysis\n9. Unstable angina\n10. Stroke or MI within 3 months of planned treatment date\n11. Active systemic infection and\u002For mycotic aneurysm\n12. Uncorrectable coagulopathy or other bleeding diathesis\n13. Known allergy to device material or contrast material that cannot be adequately pre-medicated\n14. Body habitus that would preclude adequate fluoroscopic visualization of aorta\n15. Pregnancy or lactation (confirmed per standard of care surgical practice)\n16. Major, unrelated surgical procedure planned ≤30 days from endovascular repair\n17. Patient is ≤30 days beyond primary endpoint for another investigative clinical drug\u002Fdevice trial\n18. Social or psychological issues that would interfere with ability to comply with all study procedures for the duration of the study\n19. Can be treated in accordance with the instructions for use with a legally marketed endovascular device, including a manufacturer-fabricated custom device\n20. Can enroll in a manufacturer-sponsored clinical study at our institution or is willing and eligible to participate in a study with a manufacturer-made device at another institution",{"count":335,"type":21},[24],"The primary objective is to evaluate the safety and effectiveness of surgeon modified endografts for the treatment of pararenal and thoracoabdominal aortic pathology in patients who are not candidate for traditional open repair due to comorbid issues and their anatomy is not amenable to commercially available endografts.",[108,27],"2025-04-14",{"date":401,"type":34},"2025-04-16",{"date":403,"type":34},"2023-06-06",{"date":405,"type":21},"2029-08",{"name":407,"class":41},"Konstantinos Dean Arnaoutakis, MD",{"id":409,"slug":410,"hasResults":11,"nctId":411,"briefTitle":412,"officialTitle":413,"acronym":4,"eligibilityCriteria":414,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":364,"enrollmentInfo":415,"targetDuration":4,"studyType":22,"phases":417,"briefSummary":418,"conditions":419,"keywords":420,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":425,"startDateStruct":427,"completionDateStruct":429,"leadSponsor":431,"locationsCount":42},"100552860","study-on-multibranched-stent-graft-system-in-the-treatment-of-thoracoabdominal-aortic-aneurysm-100552860","NCT06478576","Study on Multibranched Stent Graft System in the Treatment of Thoracoabdominal Aortic Aneurysm","GUo's Renovisceral Artery Reconstruction-2: a Prospective,Single Center,Single-arm Clinical Trial to Evaluate the Safety and Efficacy of a multibRANched sTEnt Graft systEm for Thoracoabdominal Aortic Aneurysm","Inclusion Criteria:\n\n1. Age ≥18 and ≤80 years;\n2. Patients diagnosed with thoracoabdominal aortic aneurysm (based on the modified Crawford classification and the 2019 European guidelines for the treatment of aortic aneurysms), and should meet at least one of the following conditions:\n\n   1. Maximum diameter of TAAA \\>50 mm,\n   2. Rapid growth of sac \\>5 mm in diameter in the most recent 6 months, or rapid growth \\>10 mm in diameter within 1 year\n   3. Symptoms related to thoracoabdominal aortic aneurysm, such as clear abdominal pain and back pain.\n3. Anatomical criteria, including:\n\n   1. Proximal landing zone 17-36 mm in diameter and ≥25 mm in length\n   2. If distal landing zone in abdominal aorta:Distal landing zone 12-36 mm in diameter and ≥20 mm in length If distal landing zone in iliac artery:Distal landing zone 7-25 mm in diameter and ≥15 mm in length\n   3. Visceral vessel landing zone 6-13 mm in diameter and ≥15 mm in length\n   4. Renal artery landing zone 4.5-9 mm in diameter and ≥15 mm in length\n4. Patients with Feasible iliofemoral artery and upper patent upper extremity access;\n5. Patients who can understand the purpose of the trial, voluntarily participate and sign the informed consent form, and are willing to complete the follow-up according to the requirements of the protocol;\n\nExclusion Criteria:\n\n1. Ruptured aortic aneurysm in unstable haemodynamic condition;\n2. Aneurysmal aortic dissection;\n3. Infected or mycotic aortic aneurysm;\n4. Patients whose systemic or local infection may increase the risk of intravascular graft infection;\n5. Patients with occlusion of the superior mesenteric artery, celiac trunk, or renal artery.\n6. Requiring simultaneous coverage or embolisation for bilateral internal iliac arteries;\n7. Severe stenosis, calcification, or mural thrombus at stent-graft landing zone;\n8. Diagnosis of acute coronary syndrome within 6 months; Acute coronary syndrome refers to an acute cardiac ischemia syndrome caused by the rupture or erosion of unstable atherosclerotic plaques in the coronary arteries, which is followed by the formation of fresh thrombus. It includes ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction, and unstable angina pectoris.\n9. Patients with any transient ischemic attack (TIA) or ischemic 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. An allergic history for contrast agents, anticoagulants, antiplatelet drugs, stent graft or materials of delivery system( (referring to nickel-titanium, polyester, PTFE, nylon-based polymer materials);\n15. Patients with connective tissue diseases, such as systemic lupus erythematosus, Marfan syndrome, Ehlers-Danlos syndrome, or Behcet's disease;\n16. Patients with takayasu arteritis;\n17. Patients with serious vital organ dysfunction or other serious disease;\n18. Planning pregnancy, pregnancy, or breastfeeding;\n19. The patient participated in other clinical trials or not completed or withdrawn from other clinical trials within the last 3 months at the time of screening period ;\n20. Life expectancy less than 1 year;\n21. Patients who are not appropriate for endovascular repair based on the investigators' clinical judgement.",{"count":416,"type":21},73,[24],"The objective of this study is to evaluate the feasibility of multibranched stent graft system for Endovascular Treatment of Thoracoabdominal Aortic Aneurysm(TAAA)",[27],[421,422,423],"Lifetech","multibranched stent graft system","Endovascular Treatment","2024-07-10",{"date":426,"type":34},"2024-07-12",{"date":428,"type":34},"2023-06-01",{"date":430,"type":21},"2028-05-30",{"name":432,"class":95},"Lifetech Scientific (Shenzhen) Co., Ltd.",{"id":434,"slug":435,"hasResults":11,"nctId":436,"briefTitle":437,"officialTitle":438,"acronym":4,"eligibilityCriteria":439,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":440,"targetDuration":4,"studyType":22,"phases":441,"briefSummary":442,"conditions":443,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":446,"lastUpdatePostDateStruct":447,"startDateStruct":449,"completionDateStruct":451,"leadSponsor":453,"locationsCount":42},"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":104,"type":21},[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.",[27,444,315,445],"Thoracoabdominal; Aortic, Aneurysm, Dissecting","Frailty Syndrome","2024-06-28",{"date":448,"type":34},"2024-07-01",{"date":450,"type":34},"2021-02-23",{"date":452,"type":21},"2032-07-02",{"name":454,"class":41},"University of Southern California",{"id":456,"slug":457,"hasResults":11,"nctId":458,"briefTitle":459,"officialTitle":460,"acronym":4,"eligibilityCriteria":461,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":462,"targetDuration":4,"studyType":75,"phases":4,"briefSummary":463,"conditions":464,"keywords":4,"overallStatus":465,"whyStopped":4,"lastUpdateSubmitDate":466,"lastUpdatePostDateStruct":467,"startDateStruct":469,"completionDateStruct":471,"leadSponsor":473,"locationsCount":4},"100536649","thoracoabdominal-aortic-aneurysms-100536649","NCT06267573","Thoracoabdominal Aortic Aneurysms","Outcomes of Endovascular Repair of Thoracoabdominal Aortic Aneurysms","Inclusion Criteria:\n\n* all adult consecutive patients presenting with TAAA larger than 5.5 cm\n\nExclusion Criteria:\n\n* active infection Asymptomatic patients with small aneurysms Allergy to contrast agents",{"count":104,"type":21},"Evaluation of the effectiveness of the different modalities for treatment of thoracoabdominal aortic aneurysms. FEVAR and BEVAR devices are widely used now due to its feasability and wide range of use . We aim to evaluate the effectiveness of these new devices in the management of TAAA",[27],"NOT_YET_RECRUITING","2024-02-19",{"date":468,"type":34},"2024-02-20",{"date":470,"type":21},"2024-09",{"date":472,"type":21},"2026-09-10",{"name":474,"class":41},"Assiut University",{"id":476,"slug":477,"hasResults":11,"nctId":478,"briefTitle":479,"officialTitle":480,"acronym":481,"eligibilityCriteria":482,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":483,"enrollmentInfo":484,"targetDuration":485,"studyType":75,"phases":4,"briefSummary":486,"conditions":487,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":488,"lastUpdatePostDateStruct":489,"startDateStruct":491,"completionDateStruct":493,"leadSponsor":495,"locationsCount":42},"100497561","the-safe-line-technique-as-additional-attempt-to-mitigate-spinal-cord-ischemia-after-endovascular-exclusion-of-taaa-100497561","NCT05758844","The Safe-line Technique as Additional Attempt to Mitigate Spinal Cord Ischemia After Endovascular Exclusion of TAAA","The Safe-line Technique as Additional Attempt to Mitigate Spinal Cord Ischemia After Endovascular Thoraco-abdominal Aneurysm Repair","Safe-line-tech","Inclusion Criteria:\n\n* Thoraco-abdominal aortic aneurysm including type I,II,III,IV and V.\n* Pararenale aneurysm\n* Thoracoabdominal aortic aneurysm Elective and Urgent, endovascular repair;\n* Endovascular repair of any thoracoabdominal aortic condition\n\nExclusion Criteria:\n\n-thoraco-abdominal aortic aneurysm open repair","100 Years",{"count":104,"type":21},"1 Year","To assess safety and feasebility of the \"safe-line\" technique in a multicenter international collaboration.",[27],"2023-03-04",{"date":490,"type":34},"2023-03-08",{"date":492,"type":21},"2023-04-30",{"date":494,"type":21},"2026-12-01",{"name":496,"class":41},"University Hospital Padova"]