[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"thoracoabdominal-aneurysm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:thoracoabdominal-aneurysm":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,52,80],{"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":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":66,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":79},"100294327","repair-of-thoracoabdominal-aortic-aneurysms-100294327","NCT03111459","Repair of Thoracoabdominal Aortic Aneurysms","Endograft Repair of Thoracoabdominal Aortic Aneurysms (TAAA)","Inclusion Criteria:\n\n1. A patient may be entered into the study if the patient has at least one of the following:\n\n   1. an aneurysm with a maximum diameter of \\> 5.5 cm 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 greater than 4.5 cm\n2. Axillary or brachial and iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices or accessories, with or without use of a surgical conduit.\n3. Proximal landing zone for the thoracic bifurcation stent graft that has:\n\n   1. ≥ 2.5 cm of nonaneurysmal aortic segment including previously placed graft material (neck) distal to the left subclavian artery (LSA) diameter in the range of 26-42 mm.\n   2. adequate distance from the celiac artery, in order to accommodate cannulation from the antegrade access point when considering the total deployed length of the thoracic bifurcation and visceral manifold.\n4. Minimum branch vessel diameter ≥ 5 mm.\n5. Iliac artery or aortic distal fixation site, including both native tissue and previously placed graft, greater than or equal to 15 mm in length and diameter in the range of 8 - 25 mm.\n6. Patient is ≥ 18 years of age.\n7. Patient has a life expectancy \\> 1 year.\n\nExclusion Criteria:\n\n1. Patient is a good candidate for and elects open surgical repair.\n2. Patient can be treated in accordance with the instructions for use with a legally marketed endovascular prosthesis.\n3. Patient is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site.\n4. Patient is unwilling to comply with the follow-up schedule.\n5. Patient is unable or refuses to give informed consent.\n6. Urgent or emergent presentation.\n7. Patient is pregnant or breastfeeding.\n8. Patient has a contained rupture.\n9. Patient has a ruptured aneurysm.\n10. Patient has a dissection in the treated portion of the aorta.\n11. Obstructive stenting of any or all of the visceral vessels.\n12. Poor performance status including 2 major system failures (cardiovascular, renal, hepatobiliary, neuromuscular).\n\nMedical Exclusion Criteria:\n\n1. Patient has known sensitivities or allergies to the materials of construction of the devices, including nitinol (Nickel: Titanium), polyester, platinum-iridium, polytetrafluoroethylene (PTFE), platinum, gold, polyethylene, or stainless steel.\n2. Patient has known hypersensitivity or contraindication to anticoagulation or contrast media that cannot be adequately medically managed.\n3. Patient has an uncorrectable coagulopathy.\n4. Patient has a body habitus that would inhibit x-ray visualization of the aorta or exceeds the safe capacity of the equipment.\n5. Patient has had a major surgical or interventional procedure. unrelated to the treatment of the aneurysm planned \\\u003C 30 days of the endovascular repair.\n6. Patient has unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina).\n7. Patient has a systemic or local infection that may increase the risk of endovascular graft infection.\n8. Baseline creatinine greater than 2.0 mg\u002FdL.\n9. History of connective tissue disorders (e.g., Marfan Syndrome, Ehler's Danlos Syndrome).\n\nAnatomical Exclusion Criteria:\n\n1. Thrombus or excessive calcification within the neck of the aneurysm.\n2. Anatomy that would not allow maintenance of at least one patent hypogastric artery.\n3. Anatomy that would not allow primary or assisted patency of the left subclavian artery.\n\nExpanded Selection Criteria:\n\nSubjects who fail to meet inclusion criteria for the primary study arm may be enrolled under an expanded selection arm if they meet the following criteria.\n\nInclusion Criteria:\n\n1. Patient that meets the criteria for inclusion in the primary study arm but has one or more of the following criteria which would exclude them from the primary study arm:\n\n   1. Patient has a minimum branch vessel diameter less than 5 mm.\n   2. Patients presents urgently or emergently.\n   3. Patient has a contained rupture.\n   4. Patient has a ruptured aneurysm.\n   5. Patient has a type B dissection (subacute or chronic) in the portion of the aorta intended to be treated.\n   6. Patient has poor performance status including two major system failures (cardiovascular, pulmonary, renal, hepatobiliary, and neuromuscular).\n   7. Patient's baseline creatinine greater than 2.0 mg\u002FdL.\n   8. Patient's anatomy that would not allow for maintenance of at least one hypogastric artery.\n   9. Patient's anatomy that would not allow for primary or assisted patency of the left subclavian artery.\n\n   Or\n2. Patient that meets the criteria for inclusion in the primary study arm and:\n\n   1. Would not be eligible for the primary study arm per a documented reason other than those outlined above, and\n   2. Per the opinion of the Principal Investigator, with concurrence of the IRB, alternative therapies are unsatisfactory and the probable risk of using the investigational device is no greater than the probable risk from the disease or condition.",{"count":60,"type":21},15,"INTERVENTIONAL",[63],"NA","The primary objective of the clinical investigation is to assess the use of the Medtronic Valiant Thoracoabdominal Stent Graft System to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy. The primary intent of the study is to assess safety and preliminary effectiveness of the device. Additionally, the study will assess technical success and treatment success at each follow-up interval.",[27],[67],"endograft repair,","RECRUITING","2024-02-06",{"date":71,"type":44},"2024-02-08",{"date":73,"type":44},"2017-08-01",{"date":75,"type":21},"2029-05",{"name":77,"class":78},"The Christ Hospital","OTHER",1,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":61,"phases":90,"briefSummary":91,"conditions":92,"keywords":97,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":79},"100480061","safety-and-effectiveness-of-surgeon-modified-stent-grafts-fortreatment-of-complex-aortic-aneurysms-100480061","NCT05531084","Safety and Effectiveness of Surgeon-Modified Stent Grafts forTreatment of Complex Aortic Aneurysms","Safety and Effectiveness of Surgeon-Modified Fenestrated and Branched Endografts in Treating Subjects With Complex Aortic Aneurysms","Assets","Inclusion Criteria:\n\n* Age: ≥ 18 years old\n* The subject has one or more of the following:\n\n  1\\. An aneurysm with a maximum diameter of \\> 5.5 cm (in men) and 5 cm (in women) or 2 times the normal diameter just proximal to the aneurysm using orthogonal (i.e, perpendicular to the centerline) measurements 2. Aneurysm with a history of growth \\> 0.5 cm in 6 months or clinically indicated for repair based on symptoms 3. Symptomatic aneurysm 4. Ruptured aneurysm 6. Failed previous EVAR defined as type IA endoleak or increase in aneurysm sac size in the setting of proximal seal loss 7. Saccular aneurysm deemed by the treating vascular specialist at significant risk for rupture 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. Physiological high risk For this IDE, physiological risk will be assessed using two systems. First, this study will use the Society for Vascular Surgery (SVS)\u002FAmerican Association for Vascular Surgery (AAVS) medical comorbidity grading system recommended for use by the SVS to describe the severity of medical comorbidities in patients with complex aortic aneurysm disease. However, as the current SVS\u002FAAVS grading system has yet to be validated in prospective studies or in a large cohort of patients treated for aortic disease, the American Association of Anesthesiologists grading system will also be utilized due to its widely adopted use and simplicity although it relies on subjective parameters and lacks specific metrics that affect outcomes.\n* American Association of Anesthesiologists grading system: subjects with ASA scores of 3-5 will be considered for study inclusion though final subject approval will be at the discretion of the treating vascular specialist; subjects with ASA scores of 6 will be excluded.\n* SVS\u002FAAVS grading system: high risk (8-20% mortality risk) subjects will be considered for study inclusion though final subject approval will be at the discretion of the treating vascular specialist; prohibitive high risk (31-70% mortality risk) subjects will be excluded.\n\nMedical Inclusion Criteria\n\n* American Association of Anesthesiologists (ASA) physical status classification system: subjects with ASA scores of 1-5 will be considered for study inclusion though final subject approval will be at the discretion of the treating vascular specialist; subjects with ASA scores of 6 will be excluded.\n\nSVS\u002FAAVS grading system: low risk (0.12-1% mortality risk), medium risk (1.7-4.9% mortality risk), and high risk (8-20% mortality risk) subjects will be considered for study inclusion though final subject approval will be at the discretion of the treating vascular specialist; prohibitive high risk (31-70% mortality risk) subjects will be excluded.\n\nAnatomical Inclusion Criteria\n\n* Iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices, or accessories, with or without use of a surgical conduit\n* Extent of aorta to be treated: infrarenal aortic aneurysms with \\\u003C 10 mm neck length, juxtarenal or pararenal aneurysms that include 1 or 2 renal arteries; paravisceral and extent IV-V thoracoabdominal aneurysms, Extent I-III thoracoabdominal aneurysm including those patients requiring a carotid-left subclavian bypass in order to achieve, at least, 20 mm of proximal landing zone\n* Non-aneurysmal aortic segment proximal to the aneurysm (neck) with a:\n\n  1. Minimum neck length of 20 mm\n  2. Diameter in the range of 20 mm - 38 mm\n  3. Angle less than 60 degrees relative to the axis of the aneurysm\n  4. Angle less than 60 degrees relative to the axis of the suprarenal aorta\n* Minimum branch vessel diameter of 5 mm or greater Iliac artery distal fixation site greater than 45 mm in length and diameter in the range of 8 mm to 17 mm\n\nExclusion Criteria:\n\n* Age: \\\u003C 18 years old\n* Does not meet the above inclusion criteria\n* Can be treated in accordance with the instructions for use with a commercially approved and marketed endovascular prosthesis\n* Is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site with the exception of percutaneous aortic valve surgery\n* Unwilling or unable to comply with the follow-up schedule\n* Inability or unwillingness of patient or patient's legally authorized representative to provide informed consent.\n* Subject is pregnant or breastfeeding\n* Any other circumstance or condition which, at the discretion of the sponsor-investigator, makes the patient unsuitable for inclusion Medical Exclusion Criteria\n* Known sensitivities or allergies to the materials of construction of the devices, including but not limited to titanium and PTFE.\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* Subject has had a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned \\\u003C 30 days of the endovascular repair\n* Unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest, or nocturnal angina)\n* Systemic or local infection that may increase the risk of endovascular graft infection\n* Baseline creatinine greater than 2.0 mg\u002FdL\n* History of connective tissue disorders (e.g., Marfan Syndrome, Ehler's Danlos Syndrome) with the exception of patients who have had prior open surgical aortic replacement where a surgical graft would serve as a \"landing zone\" for the investigational stent-graft Anatomical Exclusion Criteria\n\n  1. Significant occlusive disease, tortuosity, or calcification that would prevent endovascular access\n  2. Proximal neck length ≤20 mm\n  3. Proximal neck, measured outer wall to outer wall on a sectional image (CT)\n\n     1. For use of Zenith Fenestrated: diameter \\>32 mm or \\\u003C18 mm\n     2. For use of Zenith Alpha Thoracic: diameter \\>38 mm or \\\u003C18 mm (for proximal and distal neck diameter)\n     3. Zenith TX2 Dissection Endovascular graft: diameter 38 mm or \\\u003C18 mm\n     4. Zenith Flex AAA endovascular graft: diameter \\>32 mm or \\\u003C 18 mm\n  4. Proximal neck angulated more than 60 degrees relative to the long axis of the aneurysm\n  5. Proximal neck diameter changes over the length of the proximal seal zone \\>4 mm\n  6. Proximal seal site with a circumferential thrombus\u002Fatheroma\n  7. 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)\n  8. Ipsilateral iliac artery fixation site diameter, measured inner wall on a sectional image (CT) \\>21 mm at distal fixation site\n  9. Iliac artery distal fixation site \\\u003C10 mm in length\n  10. Non-bifurcated segment of any artery to be stented \\\u003C 15 mm in length\n  11. Artery to be stented with a maximum diameter \\\u003C3 mm or \\>10 mm at the vessel ostium\n  12. Inability to maintain at least one patent hypogastric artery\n  13. Bilateral renal artery stenosis \\>80%\n  14. Superior mesenteric artery stenosis \\>80%",{"count":89,"type":21},25,[63],"The primary objective of the present study is to evaluate the safety, effectiveness, and clinical outcomes of surgeon-modified fenestrated stent grafts used to treat patients with failed previous infrarenal repairs (failed EVAR) and complex aortic aneurysms (thoracoabdominal, juxtarenal, pararenal, and paravisceral aneurysms).",[27,93,94,95,96],"Juxtarenal Aortic Aneurysm","Pararenal Aneurysm","Aortic Aneurysm","Failed Previous Infrarenal Repairs (Failed EVAR)",[98],"surgeon-modified fenestrated stent grafts","2022-10-03",{"date":101,"type":44},"2022-10-06",{"date":103,"type":21},"2022-10-01",{"date":105,"type":21},"2032-10-01",{"name":107,"class":78},"Jesse Manunga, MD"]