[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"aortic-aneurysm-thoracoabdominal\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:aortic-aneurysm-thoracoabdominal":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,46,74,108],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100285001","physician-modified-fenestrated-and-branched-aortic-endografting-for-taaa-100285001",false,"NCT02989948","Physician-Modified Fenestrated and Branched Aortic Endografting for TAAA","Safety and Effectiveness of Physician-Modified Fenestrated and Branched Aortic Endografting for the Treatment of Thoracoabdominal Aortic Aneurysms (TAAA)","MAIN ARM - Inclusion Criteria:\n\n1. Must be a man or woman 50 years of age or older by the date of informed consent.\n2. Must have a thoracoabdominal aortic aneurysm of any Crawford classification (extent I-V) that extends no more proximal than the left subclavian artery.\n3. Must have an aneurysm size that meets standard indications for surgical repair (6.0 cm in maximum diameter in the descending thoracic aorta, or 5.5 cm in maximum diameter in the abdominal aorta).\n4. Must be considered, in the judgment of the S-I, to be a high risk candidate for open surgical repair.\n5. Must not be a candidate for repair under the Instructions for Use of a commercially available, FDA-approved endovascular graft.\n6. Must be able to provide informed consent.\n7. Must be able to comply with the five year study assessment schedule of events.\n8. Must have a non-aneurysm-related life expectancy, in the judgment of the S-I, of greater than 2 years.\n\nMAIN ARM - Exclusion Criteria:\n\n1. Aneurysm due to acute or chronic dissection, intramural hematoma, penetrating aortic ulceration, pseudoaneurysm, mycotic aneurysm, or traumatic transection.\n2. Ruptured or acutely symptomatic aortic aneurysm.\n3. Known connective tissue disorder.\n4. Imaging demonstrating any of the following:\n\n   * Lack of 20 mm non-aneurysmal proximal seal zone (zone 3, or zone 2 with a carotid-subclavian bypass or transposition).\n   * Lack of 15 mm non-aneurysmal distal seal zone(s) (aortic, common iliac, or external iliac).\n   * Branch vessel target (renal, superior mesenteric, or celiac) \\\u003C 5 mm or \\> 10 mm in average diameter.\n   * Untreated left subclavian artery stenosis or occlusion.\n   * Untreated unilateral or bilateral hypogastric artery occlusion.\n   * Signs that the inferior mesenteric artery is indispensable.\n   * Have branching, duplication, aneurysm, or untreatable stenosis of the celiac, superior mesenteric artery, or renal arteries that would preclude implantation of the investigational devices.\n5. Known sensitivities or allergies to stainless steel, PTFE, polyester, polypropylene, nitinol, or gold.\n6. History of anaphylaxis to contrast, with inability to prophylax appropriately.\n7. Have uncorrectable coagulopathy.\n8. Have unstable angina.\n9. Have a body habitus that would inhibit X-ray visualization of the aorta.\n10. Have a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned ≤30 days of the endovascular repair.\n11. Known to be participating in any other clinical study which may affect performance of this device.\n12. Known, visible, or suspected pregnancy, confirmed with a Urine Pregnancy Test (UPT)\n13. Contraindication to oral antiplatelet therapy.\n14. Prisoners or those on alternative sentencing.\n15. Known systemic infection with potential for endovascular graft infection.\n16. Anticipated need for MRI scanning within 3 months of insertion of investigational product.\n17. Other conditions or comorbidities that, in the opinion of the S-I, would exclude the patient.\n\nEXPANDED ACCESS ARM - Inclusion Criteria\n\n1. Must be a man or woman 50 years of age or older by the date of informed consent\n2. Must have a thoracic, thoracoabdominal, or abdominal aortic aneurysm that necessitates coverage of one or more visceral vessels (celiac, superior mesenteric, or renals) for establishment of proximal and\u002For distal seal.\n3. Must have an aneurysm size that meets standard size indications for surgical repair (6.0 cm in maximum diameter in the descending thoracic aorta, or 5.5 cm in maximum diameter in the abdominal aorta); or, in the judgment of the S-I, has aneurysm characteristics that portend a high risk of near-term rupture\n4. Must be considered, in the judgement of the S-I, to be a high risk candidate for open surgical repair\n5. Must not be a candidate for repair under the Instructions for Use of a commercially available, FDA-approved endovascular graft\n6. Patient must be able to provide informed consent\n7. Must be able to comply with the five year study assessment schedule of events\n8. Must have a non-aneurysm-related life expectancy, in the judgement of the S-I, of greater than 2 years\n\nEXPANDED ACCESS ARM - Exclusion Criteria\n\n1. Known or suspected mycotic aneurysm\n2. Ruptured aneurysm with hemodynamic instability\n3. Known connective tissue disorder\n4. Imaging demonstrating any of the following:\n\n   * Lack of 20 mm non-aneurysmal proximal seal zone (in either native aorta, elephant trunk graft, or aortic arch endograft)\n   * Lack of 15 mm non-aneurysmal distal seal zone(s) (in either native aortoiliac vessels, prosthetic aortoiliac grafts, or aortoiliac endografts)\n   * Branch vessel target (renal, superior mesenteric, or celiac) \\> 10 mm in average diameter\n5. Known sensitivities or allergies to stainless steel, PTFE, polyester, polypropylene, nitinol, or gold\n6. History of anaphylaxis to contrast, with inability to prophylax appropriately.\n7. Have uncorrectable coagulopathy\n8. Have a body habitus that would inhibit X-ray visualization of the aorta\n9. Have a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned ≤ 30 days of the endovascular repair\n10. Known to be participating in any other clinical study which may affect performance of this device\n11. Known, visible, or suspected pregnancy, confirmed with a Urine Pregnancy Test (UPT)\n12. Contraindication to oral antiplatelet therapy\n13. Prisoners or those on alternative sentencing\n14. Known systemic infection with potential for endovascular graft infection\n15. Anticipated need for MRI scanning within 3 months of insertion of investigational product\n16. Other conditions or comorbidities that, in the opinion of the S-I, would exclude the patient","ALL","50 Years","95 Years",{"count":20,"type":21},80,"ESTIMATED","INTERVENTIONAL",[24],"NA","The primary clinical objective of this study is to evaluate the safety and effectiveness of a physician-modified, fenestrated and branched aortic endoprosthesis for the treatment of thoracoabdominal aortic aneurysms (TAAAs). The goal of the primary analysis is to demonstrate both the safety and effectiveness of using a physician-modified fenestrated Cook Zenith Alpha Thoracic Endovascular Graft as compared to previously published results of open surgical replacement of the aneurysmal aorta.",[27],"Aortic Aneurysm, Thoracoabdominal",[29,30,31,32],"endovascular","physician-modified","graft","fenestration","RECRUITING","2026-04-21",{"date":36,"type":37},"2026-04-27","ACTUAL",{"date":39,"type":37},"2020-04-22",{"date":41,"type":21},"2031-12-31",{"name":43,"class":44},"Yale University","OTHER",2,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":54,"sex":16,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100626645","ai-care-artificial-intelligence-for-cardiovascular-analysis-and-risk-evaluation-100626645","NCT07438327","AI-CARE: Artificial Intelligence for Cardiovascular Analysis and Risk Evaluation","AI-CARE: Artificial Intelligence for Cardiovascular Analysis and Risk Evaluation - Clinical Evaluation of Aorta Automated Imaging Measurement (Aorta AIM)","AI-CARE","* Adults ≥22 years at time of imaging\n* Studies performed 1 Jan 2016 - 31 August 2025\n* CT imaging of the whole, thoracic, or abdominal aorta, with or without contrast enhancement, acquired with any gating protocol (including non-gated)\n* Slice thickness ≤ 3mm\n* CT imaging in which truncation creates discontinuity within a targeted aortic region, preventing reliable diameter measurement (e.g., cardiac-focused CT acquisitions where an incomplete or absent aortic arch creates discontinuity between the aortic root and the descending thoracic aorta)\n\n  o Partial aortic coverage is not grounds for exclusion. Where truncation affects individual regions, only those specific regions will be excluded from analysis; remaining fully captured regions will be retained for measurement.\n* Metal implants \\\u003C5cm from aorta (e.g. thoracic stent)\n* Prior aortic surgery\n* Severe motion artifacts (e.g. \\>3mm vessel blurring)\n* Congenital aortic anomalies (e.g. coarctation, vascular rings)\n* Post-traumatic aortic repairs\n* The patient opted out of having their data used for medical research before the date of cross-referencing by the site team",true,"22 Years",{"count":57,"type":21},250,"OBSERVATIONAL","This study will test how well an artificial intelligence (AI) software called Aorta AIM measures the size of the aorta (the body's main blood vessel) from CT scans. The aorta can become enlarged over time, which may lead to serious health problems. Doctors need to measure the aorta accurately to monitor patients and decide on treatment.\n\nCurrently, doctors measure the aorta manually on CT scans, which takes time and can vary between different doctors. Aorta AIM is designed to measure the aorta automatically and consistently.\n\nIn this study, researchers will compare Aorta AIM's measurements to those made by experienced radiologists or cardiologists (doctors who specialize in reading medical images). The study will use CT scans that have already been taken as part of routine medical care - no additional scans or procedures are needed.\n\nThe study will include approximately 250 participants across multiple hospitals in Brazil and the United States. Participants will be adults who have had a chest or abdominal CT scan that shows their aorta.\n\nThe main goals are to:\n\n* Check if Aorta AIM measures the aorta as accurately as radiologists\n* See if Aorta AIM can help doctors work more efficiently\n* Evaluate if the software works well in different hospital settings and with different types of patients\n\nThis research may help improve how doctors monitor aortic disease and make treatment decisions in the future. There are no risks to participants since the study only uses existing medical images.",[61,62,63,27],"Aortic Aneurysm","Aortic Aneurysm Abdominal","Aortic Aneurysm and Dissection","2026-03-31",{"date":66,"type":37},"2026-04-06",{"date":64,"type":37},{"date":69,"type":21},"2026-09-05",{"name":71,"class":72},"Aiatella Oy","INDUSTRY",3,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":81,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":22,"phases":84,"briefSummary":85,"conditions":86,"keywords":89,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":45},"100233962","endovascular-treatment-of-taaa-and-aortic-arch-aneurysms-using-fenestrated-and-branched-stent-grafts-100233962","NCT02323581","Endovascular Treatment of TAAA and Aortic Arch Aneurysms Using Fenestrated and Branched Stent Grafts","Feasibility, Safety, and Clinical Outcomes of Endovascular Treatment of Thoracoabdominal Aortic Aneurysms and Aortic Arch Aneurysms Using Fenestrated and Branched Stent Grafts","TAAA STUDY ARM\n\nInclusion Criteria:\n\n1. Presence of TAAA in:\n\n   1. Men with TAAA greater than or equal to 6 cm in diameter\n   2. Women with TAAA greater than or equal to 5 cm in diameter\n   3. Men with TAAA larger than 5 cm in diameter and enlarging at a rate of more than 10mm\u002Fyear\n   4. Women with TAAA larger than 4.5 cm in diameter and enlarging at a rate of more than 10mm\u002Fyear or\n   5. Men or women with TAAA and an iliac artery aneurysm greater than or equal to 4 cm in diameter\n2. Life expectancy more than 2 years\n3. Ability to give informed consent, complete pre-treatment assessments and comply with the follow-up schedule per protocol\n4. Suitable arterial anatomy for endovascular TAAA repair with \"TAAA device\":\n\n   1. Proximal aortic landing zone:\n\n      * ≥ 20mm long\n      * ≤ 40mm and ≥ 20mm diameter in parallel aorta\n      * free from circumferential thrombus\n      * ≤ 60 degrees angulation\n   2. Mesenteric\u002Frenal aortic diameter ≥ 20mm\n   3. Mesenteric arteries:\n\n      * ≥ 10mm long segment of healthy artery for branch attachment\n      * Diameter ≥ 4mm and ≤ 12mm\n      * Absence of aberrant or early branching, aneurysm or dissection\n   4. Renal arteries:\n\n      * ≥ 10mm long segment of healthy artery for branch attachment\n      * Diameter ≥ 4mm and ≤ 8mm\n      * Absence of aberrant or early branching, aneurysm or dissection\n   5. Iliac artery access:\n\n      * ≥ 6mm diameter, and absence of severe calcification and tortuosity\n      * Or, planned creation of surgical conduit for TAAA device delivery\n   6. For patients with associated common iliac artery aneurysms (\\>20mm diameter), adequate internal and external iliac artery landing zones and common iliac artery luminal diameter (for iliac branch device use):\n\n      * ≥ 10mm long segment of healthy internal iliac artery for branch attachment\n      * Internal iliac diameter ≥ 5mm and ≤ 12mm\n      * External iliac diameter ≥ 6mm diameter, and absence of severe calcification and tortuosity\n      * Minimum common iliac artery luminal diameter ≥ 14mm\n      * Or, in patients with bilateral common iliac artery aneurysms without suitable anatomy, planned surgical bypass to maintain patency of at least one internal iliac artery\n5. Patients deemed high risk for open repair (meeting one, or more, of the following criteria):\n\n   1. Age ≥ 65 year\n   2. Cardiac disease:\n\n      * CAD (history of MI or angina with positive stress test and not revascularizable)\n      * LV Ejection fraction \\\u003C 40%\n      * Symptomatic CHF (NYHC Class II, III, or IV)\n   3. Pulmonary disease:\n\n      * Home oxygen therapy\n      * FEV1 \\\u003C 1.2 l\u002Fs\n      * Vital capacity \\\u003C 50% predicted\n      * PaCO2 \\> 45 mm Hg or \\\u003C 60 mm Hg\n   4. Renal disease:\n\n      * ESRD on dialysis\n      * eGFR \\\u003C 60\n   5. Prior aortic surgery\n   6. Hostile abdomen\n   7. Portal hypertension (ascites or varices)\n   8. Coagulopathy\n\nAORTIC ARCH STUDY ARM\n\nInclusion Criteria:\n\n1. Presence of aortic arch aneurysm in:\n\n   1. Men with aortic arch aneurysm greater than or equal to 6 cm in diameter, or\n   2. Women with aortic arch aneurysm greater than or equal to 5 cm in diameter, or\n   3. Men with aortic arch aneurysm larger than 5 cm in diameter and enlarging at a rate of more than 10 mm\u002Fyear, or\n   4. Women with aortic arch aneurysm larger than 4.5 cm in diameter and enlarging at a rate of more than 10 mm\u002Fyear, or\n   5. Saccular aortic arch aneurysms deemed at significant risk for rupture based upon physician interpretation\n2. Life expectancy more than 2 years\n3. Ability to give informed consent, complete pre-treatment assessments and comply with the follow-up schedule per protocol.\n4. Suitable arterial anatomy for endovascular aortic arch repair with \"Aortic Arch Device\":\n\n   1. Aneurysm of the aortic arch beginning distal to the native coronary arteries or any patent coronary artery bypass\n   2. Proximal aortic landing zone:\n\n      * Native aorta or surgical graft\n      * ≥ 20 mm long\n      * ≤ 42 mm and ≥ 20 mm diameter in parallel aorta\n      * free from circumferential thrombus\n   3. Distal aortic landing zone:\n\n      * Native aorta or surgical graft\n      * ≥ 20 mm long\n      * ≤ 42 mm and ≥ 20 mm diameter in parallel aorta\n      * free from circumferential thrombus\n      * ≥ 50mm length from native coronary arteries or patent coronary bypass graft to innominate artery\n   4. Adequate supra-aortic trunk branch landing zone(s):\n\n      * Innominate artery (if applicable):\n\n        * Native vessel or surgical graft\n        * Diameter: 8-22mm\n        * Length of sealing zone ≥10mm\n        * Acceptable tortuosity\n        * Absence of dissection in landing zone\n      * Left (or right) common carotid artery (if applicable):\n\n        * Native vessel or surgical graft\n        * Diameter 6-16mm\n        * Length of sealing zone ≥10mm\n        * Acceptable tortuosity\n        * Absence of dissection in landing zone\n      * Left (or right) subclavian artery (if applicable):\n\n        * Native vessel or surgical graft\n        * Diameter: 5-20mm\n        * Length of sealing zone ≥10mm\n        * Acceptable tortuosity\n        * Absence of dissection in landing zone\n   5. Iliac artery access:\n\n      * ≥ 6mm diameter, and absence of severe calcification and tortuosity\n      * Or, planned creation of surgical conduit for TAAA device delivery\n5. Patients deemed high risk for open surgical aortic arch repair based upon consensus of both a qualified cardiac surgeon and a qualified vascular surgeon and meeting one, or more, of the following criteria):\n\n   1. Age \\> 70 years-old\n   2. Prior ascending or aortic arch repair\n   3. Multiple (≥2) median sternotomies\n   4. Ischemic cardiomyopathy with multi-level coronary artery disease and\u002For positive stress test\n   5. Chronic pulmonary disease with FEV1 \\\u003C 1500ml\n   6. Chronic kidney disease with eGFR ≤ 60 ml\u002Fkg\u002Fhr\n   7. Large aneurysm abutting the sternotomy\n   8. Severe deconditioning or immobility\n   9. Prior cervical irradiation\n   10. Other medical condition associated with prohibitive high risk with open repair based upon multidisciplinary consensus (cardiac surgery and vascular surgery)\n\nAPPLIES TO BOTH STUDY ARMS\n\nExclusion Criteria:\n\n1. Rupture, with hypotension (systolic bp \\\u003C 90).\n2. Pregnancy or breastfeeding.\n3. Unwillingness or inability to comply with the follow up schedule.\n4. Serious systemic or groin infection.\n5. Uncorrectable coagulopathy.\n6. Age \\\u003C 18 years.\n7. Mycotic aneurysm.\n8. Known degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome (unless proximal implantation is into a previously placed surgical graft).\n9. Known sensitivities or allergies to stainless steel, nitinol, polyester, solder (tin, silver), polypropylene, urethane or gold.\n10. Participation in another in another investigational device or drug study within 1 year of treatment.\n11. Unrelated concomitant major surgical or interventional procedure(s) within 30 days of treatment date (with the exception of staged procedures planned as part of treatment)\n12. Body habitus that would inhibit X-ray visualization of the aorta.\n13. Acute aortic dissection\n14. Patients able and willing to be treated with a commercially available device or a device being evaluated in a manufacturer-sponsored pivotal study","18 Years",{"count":83,"type":21},520,[24],"Prospective, nonrandomized, single-center, two-arm study to assess the feasibility and safety and to evaluate clinical outcomes of endovascular repair of complex aortic aneurysms (thoracoabdominal aortic aneurysms and aortic arch aneurysms) in patients at high risk for open surgery.",[27,87,88],"Aortic Aneurysm, Thoracic","Aortic Dissection, Thoracoabdominal",[90,91,92,93,94,95,96,97,98],"Thoracoabdominal","Aneurysm","Endovascular","Stent-Graft","Aortic Arch","BEVAR","FEVAR","Aorta","Aortic Dissection","2025-12-11",{"date":101,"type":37},"2025-12-15",{"date":103,"type":37},"2013-11",{"date":105,"type":21},"2033-12",{"name":107,"class":44},"Darren Schneider, M.D.",{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":16,"minAge":81,"maxAge":115,"enrollmentInfo":116,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":118,"conditions":119,"keywords":121,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":133},"100543621","standardized-physician-modified-fenestrated-endograft-registry-100543621","NCT06358248","Standardized Physician-modified Fenestrated Endograft Registry","SPHERE","INCLUSION CRITERIA\n\n* Complex AAA (including short-neck AAA, JRAA, PRAA, extent IV TAAA)\n* Haemodynamic stability\n* Anatomical feasibility is based on the presence of a proximal aortic neck above the mid celiac trunk of ≥25 mm in length and between 18 mm and 35 mm in diameter; the neck needs to be \"healthy\" with no parietal calcifications or thrombus with a cylindrical shape. The visceral aorta is required to be no larger than 40 mm in maximum diameter.\n\nEXCLUSION CRITERIA\n\n* Extent I-III TAAA\n* Hemorrhagic shock","100 Years",{"count":117,"type":21},50,"Multicenter retrospective study including all consecutive patients treated by PMEG using a standard modification technique of Valiant Captivia (Medtronic, Minneapolis, MN-USA).",[27,120],"Aortic Diseases",[61,122,123],"Thoracoabdominal Aneurysm","Endovascular aortic repair","2024-04-13",{"date":126,"type":37},"2024-04-16",{"date":128,"type":37},"2023-10-01",{"date":130,"type":21},"2033-10-01",{"name":132,"class":44},"University Hospital Padova",1]