[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"complex-aortic-aneurysms\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:complex-aortic-aneurysms":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,52,94,126],{"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":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":32,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":4},"100629878","real-world-data-collection-of-gore-devices-used-in-the-endovascular-treatment-of-aortic-aneurysms-which-incorporate-visceral-arteries-100629878",false,"NCT07480395","Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.","The ENVISION Registry: REal-World Data CollectioN of GORE deVIceS Used In the endOvascular treatmeNt of Aortic Aneurysms Which Incorporate Visceral Arteries.","ENVISION","Inclusion Criteria:\n\n1. Informed Consent Form (ICF) is signed by Subject.\n2. Age ≥ 18 years at time of informed consent signature.\n3. Patient presents with thoracoabdominal, pararenal, juxtarenal, or short-neck infrarenal aortic pathology suitable for endovascular repair.\n4. Patient requires the incorporation of ≥ 1 visceral artery and is suitable for use of at least 1 GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (BXB) as a bridging stent (Note: Up to six (6) visceral arteries may be incorporated).\n5. Patient is willing to adhere to the institutional standard of care follow-up.\n\nExclusion Criteria:\n\n1. Patient has a prior visceral artery stenting not associated with registry procedure.\n2. Patient treated for acute or sub-acute dissection, \\\u003C90 days from onset of symptoms\n3. Patient is intended to be treated with a parallel grafting (e.g., chimney, periscope, sandwich) or octopus technique.\n4. Known hypersensitivity to heparin or a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II.\n5. Patient has known coagulation disorders including hypercoagulability that are not amenable to treatment.\n6. Patient has a life expectancy \\\u003C 1-year.\n7. Patient is participating in an investigational study which may confound registry results, unless approved by Gore","ALL","18 Years",{"count":20,"type":21},400,"ESTIMATED","5 Years","OBSERVATIONAL","The registry population consists of patients presenting with complex aortic pathologies amenable to endovascular aortic repair that requires the incorporation of bridging stents to maintain visceral artery perfusion",[26,27,28,29,30,31],"Complex Aortic Aneurysms","Thoracoabdominal Aneurysm","Fenestrated Endovascular Aortic Repair","Endovascular Aortic Repair","Abdominal Aorta Aneurism","Chronic Dissection",[33,34,35,36,37,38,39],"FEVAR","BEVAR","TAAA","AAA","Visceral","aortic aneurysm","PMEGs","NOT_YET_RECRUITING","2026-05-27",{"date":43,"type":44},"2026-06-01","ACTUAL",{"date":46,"type":21},"2026-12",{"date":48,"type":21},"2035-12",{"name":50,"class":51},"W.L.Gore & Associates","INDUSTRY",{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":73,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":93},"100213022","complex-aortic-aneurysm-repair-using-physician-modified-endografts-and-custom-made-devices-100213022","NCT02050113","Complex Aortic Aneurysm Repair Using Physician Modified Endografts and Custom Made Devices","CARPE-CMD","Inclusion Criteria:\n\n* A patient may be suitable for inclusion in the study if the patient has at least one of the following:\n\n  1. Aortic or aortoiliac aneurysm with diameter ≥5.5 cm\n  2. Aortic or aortoiliac aneurysm with a history of growth ≥1.0 cm per year, or clinical indication for aneurysm repair based on symptoms\n\n     General Inclusion Criteria\n\n  \u003C!-- -->\n\n  1. Cannot be treated with a currently available non-modified approved device\n  2. Symptomatic on presentation and unsafe to wait for the time necessary to obtain a currently available non-modified approved device\n  3. At least 18 years of age\n  4. Not pregnant or breastfeeding\n  5. Willing and able to comply with five years of follow-up\n  6. Willing and able to provide informed consent prior to enrollment\n  7. No systemic or local infection that may increase the risk of endovascular graft infection\n  8. High risk for open surgical repair based on any of the factors below:\n\n     a. 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 b. 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\n\n     Exclusion Criteria:\n* Exclusion Criteria Medical Exclusion Criteria\n\n  1. Cultural objection to receipt of blood or blood products\n  2. Allergy or sensitivity to stainless steel, polyester, polypropylene, solder (tin, silver), gold, or nitinol\n  3. Anaphylactic reaction to contrast that cannot be adequately pre-medicated\n  4. Uncorrectable coagulopathy\n  5. Unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina, or onset of prolonged angina)\n  6. Patient has active malignancy with life expectancy of less than 2 years\n  7. Patient has life expectancy less than two years\n\nAnatomical Exclusion Criteria\n\n1. Significant occlusive disease, tortuosity, or calcification that would prevent endovascular access\n2. Proximal neck length ≤25 mm\n3. Proximal neck, measured outer wall to outer wall on a sectional image (CT)\n\n   1. For use of Zenith Flex: diameter \\>32 mm or \\\u003C18 mm\n   2. For use of Zenith TX2: diameter \\>38 mm or \\\u003C24 mm (for proximal and distal neck diameter)\n4. Proximal neck angulated more than 60 degrees relative to the long axis of the aneurysm\n5. Proximal neck diameter change over the length of the proximal seal zone \\>4 mm\n6. Proximal seal site with a circumferential thrombus\u002Fatheroma\n7. Iliac artery diameter, measured inner wall to inner wall on a sectional image (CT) \\\u003C7.0 mm at any point along access length (prior to deployment)\n8. Ipsilateral iliac artery fixation site diameter, measured inner wall on a sectional image (CT) \\>21 mm at distal fixation site\n9. Iliac artery distal fixation site \\\u003C10 mm in length\n10. Non-bifurcated segment of any artery to be stented \\\u003C 15 mm in length\n11. Artery to be stented with a maximum diameter \\\u003C3 mm or \\>10 mm at the vessel ostium\n12. Inability to maintain at least one patent hypogastric artery",{"count":60,"type":21},600,"INTERVENTIONAL",[63],"NA","The purpose of this study is to evaluate the safety and efficacy of custom made devices, Zenith t-Branch devices and physician modification of FDA approved off-the-shelf endovascular grafts in the treatment of patients with complex abdominal aneurysms, aortoiliac aneurysms, thoracoabdominal aneurysms and aortic arch aneurysms who (1) have anatomy not suitable for endovascular repair using grafts currently marketed in the United States,(2) are deemed unsafe to wait the required time necessary for commercial endograft manufacturing, and (3) are at high risk for open surgical repair. Amendment to the study has created a cohort open to people with connective tissue diseases such as Marfan, Ehlers-Danlos or Loey-Dietz syndromes to enroll in the trial. An additional amendment to the study allows the use of a custom made device to treat an aneurysm in the aortic arch.",[26,66,67,68,69,70,71,72],"Thoracoabdominal Aneurysms","Pararenal Aneurysms","Juxtarenal Aneurysms","Marfan Syndrome","Ehlers-Danlos Syndrome","Loeys-Dietz Syndrome","Aortic Arch Aneurysm",[26,66,74,75,76,77,78,79,80,81],"Pararenal Aortic Aneurysms","Juxtarenal Renal Aneurysms","Endovascular Branch Graft","Fenestrated Stent Graft","Abdominal Aortic Aneurysm","Endovascular","Aortic Dissection","Aortic Arch Aneurysms","RECRUITING","2025-10-20",{"date":85,"type":44},"2025-10-22",{"date":87,"type":4},"2014-03",{"date":89,"type":21},"2030-03",{"name":91,"class":92},"Andres Schanzer","OTHER",1,{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":102,"enrollmentInfo":103,"targetDuration":4,"studyType":61,"phases":105,"briefSummary":107,"conditions":108,"keywords":111,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":125},"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":104,"type":21},60,[106],"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.",[109,110,26],"Thoracoabdominal Aortic Aneurysm","Endovascular Repair",[112,113,114,115],"BAO-G technique","iliac-branched devices","endovascular repair","complex aortic aneurysm","2025-08-30",{"date":118,"type":44},"2025-09-05",{"date":120,"type":44},"2022-01-01",{"date":122,"type":21},"2035-12-31",{"name":124,"class":92},"Peking Union Medical College Hospital",11,{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":61,"phases":134,"briefSummary":135,"conditions":136,"keywords":139,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":93},"100580231","physician-modified-endovascular-grafts-for-the-treatment-of-elective-symptomatic-or-ruptured-complex-aortic-aneurysms-100580231","NCT06834607","Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Complex Aortic Aneurysms","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 or Legally Authorized Representative has signed an Institutional Review Board (IRB) approved Informed Consent Form\n4. Patient has a juxtarenal abdominal aortic aneurysm that meets at least one of the following:\n\n   1. An aneurysm with a maximum diameter of ≥ 5.5 cm for male (≥ 5.0 cm for female) or 2 times the normal diameter just proximal to the aneurysm using orthogonal (i.e., perpendicular to the centerline) measurements\n   2. Aneurysm with a history of growth \\> 0.5 cm in 6 months\n   3. Saccular aneurysm deemed at significant risk for rupture\n   4. Symptomatic aneurysm\n   5. Ruptured aneurysm\n5. Patient has patent iliac or femoral arteries, with or without the use of conduit, that will allow endovascular access with the physician modified endovascular graft.\n6. Patient has a suitable non-aneurysmal proximal aortic neck of ≥ 2 mm inferior to the most distal renal artery ostium.\n7. Patient has a suitable non-aneurysmal distal iliac artery length (seal zone) of ≥ 15mm. The resultant repair should preserve patency in at least one hypogastric artery.\n8. Patient has a suitable non-aneurysmal proximal aortic neck diameter between 20 and 32 mm, averaged across the diameters at the Celiac, SMA, at the lowest patent renal artery and at the midpoint of the renal arteries.\n9. Patient has suitable non-aneurysmal distal common iliac diameters between 8 and 20 mm.\n10. Patient has juxtarenal aortic neck angulation ≤ 60°\n11. Target branch vessel diameter ≥ 5 mm.\n12. Patient must be willing to comply with all required follow-up exams.\n\nExclusion Criteria:\n\n1. Patient has a mycotic aneurysm or has an active systemic or local infection that may increase the risk of endovascular infection\n2. 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)\n3. Patient has a major surgical or interventional procedure, not related to the endovascular repair, planned within +\u002F- 30 days of the AAA repair.\n4. Patient has history of an aortopathic connective tissue disease (e.g. Marfan's or Ehler's-Danlos syndrome).\n5. Patient has a known hypersensitivity or contraindication to anticoagulation or contrast media that is not amenable to pre-treatment.\n6. Patient has known allergy or intolerance to stainless steel, nitiol, or gold (gold-plated tungsten)\n7. Patient has a body habitus that would inhibit X-ray visualization of the aorta\n8. Patient has a limited life expectancy of less than 1 year\n9. Patient is currently participating in another investigational device or drug clinical trial\n10. 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.\n11. Thrombus or excessive calcification within the neck of the aneurysm\n12. Branch vessel stenosis ≥ 80 %\n13. Patients treatable on label with FDA approved EVAR or FEVAR device and can wait for device availability.\n14. Subject is willing and eligible to enroll in a manufacturer-sponsored study at the investigational site, or the subject is willing and eligible to participate in a study with a manufacturer-made device at another institution.\n\n    \\-",{"count":133,"type":21},15,[63],"The primary objective of the clinical investigation \"Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Complex Aortic Aneurysms\" is to assess the use of the Physician-Modified Endovascular Grafts to repair juxtarenal aneurysms in high-risk subjects considered to be high risk candidates for open surgical repair, have limited or no other options for on label treatment with an FDA approved device, and having appropriate anatomy.",[137,26,138],"Juxta Renal Abdominal Aortic Aneurysm Without Rupture","Aortic Aneurysm",[140,141,142,143],"Physician Modified Endograft","PMEG","Complex aortic aneurysms","Juxta renal aortic aneurysm","2025-08-19",{"date":146,"type":44},"2025-08-24",{"date":148,"type":44},"2025-06-01",{"date":150,"type":21},"2032-05-01",{"name":152,"class":92},"Akhilesh Jain"]