[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"aortic-aneurysm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:aortic-aneurysm":26},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,31,0,25,[9,40,81,103,116,144,173,201,222,257,281,308,326,347,367,386,411,438,457,497,524,548,574,601,620],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100053496","prospective-evaluation-of-physician-modified-endografts-for-aortic-disease-100053496",false,"NCT07611968","Prospective Evaluation of Physician Modified Endografts for Aortic Disease","Inclusion Criteria:\n\n* An aneurysm with a maximum diameter of \\>5.5cm in males and \\>5.0cm in females in diameter just proximal to the aneurysm using orthogonal (i.e., perpendicular to the centerline) measurements\n* Aneurysm with a history of growth \\> 0.5 cm in 6 months\n* Saccular aneurysm deemed at significant risk for rupture\n* Symptomatic aneurysm\n* Extent of aorta to be treated: type II, III and IV thoracoabdominal.\n* Subject is at high-risk of morbidity and mortality with open surgical repair as defined by FEV1 of \\\u003C1 liter or uncorrectable coronary disease, frailty, hostile abdomen.\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* Non-aneurysmal aortic segment proximal to the aneurysm (neck) with a:\n* Minimum neck length of 15mm\n* Diameter in the range of 17-32\n* Minimum branch vessel diameter greater than 5 mm\n* Iliac artery distal fixation site\n* An inside diameter of 8mm - 13mm and a length of ≥ 10mm or\n* an inside diameter of \\> 13mm - 20mm and a length of ≥ 15mm\n* Age: ≥50 years old\n\nExclusion Criteria:\n\n* Can be treated in accordance with the instructions for use with a legally marketed endovascular prosthesis\n* Is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site\n* 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* Ruptured aneurysms\n* Prior aortic repair\n* Patient is eligible for treatment with an FDA-approved marketed device and patient 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.\n* Known sensitivities or allergies to the materials of construction of the devices, including nitinol, polyester, PTFE, stainless steel, platinum\u002Firidium, tantalum markers.\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 exceed 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 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* Thrombus or excessive calcification within the neck of the aneurysm\n* Branch stenosis \\>50% not amenable to endovascular preparation","ALL","50 Years",{"count":19,"type":20},20,"ESTIMATED","INTERVENTIONAL",[23],"NA","The purpose of this research is to assess safety and preliminary effectiveness of the Physician-Modified Terumo Treo Abdominal Stent-Graft System.",[26],"Aortic Aneurysm","RECRUITING","2026-07-09",{"date":30,"type":31},"2026-07-13","ACTUAL",{"date":33,"type":31},"2026-07-10",{"date":35,"type":20},"2028-07-15",{"name":37,"class":38},"Mayo Clinic","OTHER",1,{"id":41,"slug":42,"hasResults":12,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":12,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":52,"conditions":53,"keywords":59,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":80},"100598968","a-study-to-evaluate-the-safety-and-effectiveness-of-the-rapidlink-device-when-used-in-patients-undergoing-an-open-surgical-procedure-to-repair-the-aorta-100598968","NCT07078383","A Study to Evaluate the Safety and Effectiveness of the Rapidlink Device When Used in Patients Undergoing an Open Surgical Procedure to Repair the Aorta","Evaluation of the Rapidlink Device for Use in the Repair or Replacement of the Supra-Aortic Vessels During an Open Surgical Procedure of the Thoracic Aorta","RAPID","Inclusion Criteria:\n\n* Patient is aged 18 years or over on date of consent\n* Written informed consent (from patient or a legally authorized representative) to participate in study, documenting willingness and ability to comply with all study procedures and study visits (unless an exemption for emergency cases has been IRB \u002F EC approved)\n* Patient's need for open surgical repair of the thoracic aorta using a Gelweave graft or a Thoraflex Hybrid device (AnteFlo or Plexus) in line with the applicable IFU\n* Anticipated need to use Rapidlink for the repair or replacement of the LSA, LCCA and\u002For IA during the open surgical repair\n* Patient has an 8-15 mm inner diameter (target SAV)\n* The diameters of the patient's target supra-aortic vessel(s), fall within the ranges specified in the IFU\n\nExclusion Criteria:\n\n* Patient does not have a clear landing zone equal to the implantable stent length which is free from stenosis, calcification or thrombus.\n* Patient does not have a sealing zone free from tortuosity.\n* Patient has significant angulation (\\>79° with an internal radius of less than 6mm) for the full implantable stent length\n* Patient cannot receive anticoagulation \u002F antiplatelet therapy during or after the index procedure as per the protocol\n* Patient has uncontrolled hypercoagulation\n* Patient has a condition which may compromise or prevent the necessary imaging requirements\n* Patient has anatomic variants which would compromise circulation to the first branch off the target artery after placement of the Rapidlink device (unless planned and\u002For otherwise revascularized)\n* Patient is unfit for open surgical repair involving circulatory arrest per the study investigator\n* Patient has known sensitivity to polyester, nitinol, tantalum, or materials of bovine origin\n* Patient has a ruptured aorta\n* Patient has active endocarditis or an active infective disorder of the aorta\n* Patient has an active systemic infection that, in the opinion of the investigator, would compromise the outcome of the surgical procedure\n* Patient is enrolled in another active study and has received an investigational product (device, pharmaceutical or biologic) within 6 months prior to the date of the implant or has not reached the primary endpoint of the study\n* Patient is female and is pregnant or planning to become pregnant during the course of the study. Females of childbearing potential must use acceptable methods of contraception during the course of the study.\n* Patient has an uncorrectable bleeding anomaly\n* Patient has renal failure (defined as dialysis dependent or serum creatinine ≥2.5mg\u002FdL)\n* Patient has known sensitivity to radiopaque contrast agents that cannot be adequately pre-treated\n* Patient has a co-morbidity causing expected survival to be less than 1 year\n* Patient has any other medical, social or psychological problems that in the opinion of the investigator preclude them from receiving this treatment and the procedures and evaluations pre and post procedure\n* Patient has a known chronic aortic dissection involving the intended landing zone of the target supra-aortic vessel(s)","18 Years",{"count":50,"type":20},150,[23],"The Goal of this Clinical Study is to evaluate the safety and effectiveness of the Rapidlink device in the repair or replacement of the supra-aortic vessels during open surgical repair of aortic disease affecting the thoracic aorta.\n\nThis study will collect information on patients who are already having surgery to repair their aorta and who will have Rapidlink device implanted into one or more of the aortic arch vessels.\n\nThe first 32 subjects enrolled will undergo left subclavian artery repair or replacement, only, with the Rapidlink device. After the 32nd subject, enrollment will proceed to include subjects undergoing any supra-aortic vessel (i.e., left subclavian artery, left common carotid artery, and\u002For innominate artery) repair or replacement with the Rapidlink device in a planned surgery.\n\nAfter the 32nd subject is enrolled in the main group, up to 30 subjects will undergo supra-aortic vessel (i.e., left subclavian artery, left common carotid artery, and\u002For innominate artery) repair or replacement with the Rapidlink device in an emergency setting.\n\nData will be collected before, during and after surgery including recovery at discharge, 30 days, 6 months, 1 and 2 years after the surgery.",[26,54,55,56,57,58],"Aortic Aneurysm and Dissection","Aortic Diseases","Aneurysm of Aorta, Thoracic","Aneurysmal Disease","Aorta, Thoracic Pathologies",[60,61,62,63,64,65,66,67,68,69],"Vascular Prosthesis","Replacement or bypass of disease vessels","aneurysmal disease","Aortic branch vessels","Open aortic arch repair","aneurysm","dissection","Supra-aortic Vessels","Frozen Elephant Trunk","Left Subclavian Artery","2026-07-01",{"date":72,"type":31},"2026-07-02",{"date":74,"type":31},"2025-12-19",{"date":76,"type":20},"2028-11",{"name":78,"class":79},"Vascutek Ltd.","INDUSTRY",22,{"id":82,"slug":83,"hasResults":12,"nctId":84,"briefTitle":85,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":12,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":21,"phases":90,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":102},"100558302","radiation-free-study-100558302","NCT06549348","Radiation Free Study","RadFree","Inclusion Criteria:\n\n* Subject will be undergoing a primary Fenestrated Endovascular Aortic Repair (FEVAR) procedure (including subjects with prior infrarenal EVAR or open repair) that includes the incorporation of visceral arteries into the repair.\n* Subject is able to give informed consent and is 18 years of age or older, or of legal age to give informed consent per state or national law.\n* Subject has a life expectancy of at least 2 years\n* Target vessels to be included are the Celiac Trunk, Superior Mesenteric Artery and Renal Arteries\n\nExclusion Criteria:\n\n* Subjects undergoing an endovascular procedure that include branches or iliac branched devices (IBD) in the repair\n* Subject treated for re-intervention \u002F staged procedure post-primary FEVAR procedure\n* Subjects intended to be treated for more than 4 target vessels (not counting the contralateral gate)\n* Subject treated for an emergent (\\\u003C24hrs after emergence) procedure\n* Subject with connective tissue disorder eg, Marfan's or Ehlers Danlos Syndrome\n* Subject with contrast allergies\n* Subject participates in a potentially confounding drug or device trial during the course of the study. Co-enrollment in concurrent trials may be allowed provided that pre-approval is obtained from Philips.\n* All vulnerable subjects such as immuno-compromised subjects, subjects lacking the capacity to provide consent, patients in emergency situations, pregnant or breast-feeding women, or any other subject who meets an exclusion criteria, according to applicable national laws, if any.\n* Subject unwilling or unable to comply with the protocol unable to understand verbal and\u002For written informed consent",{"count":89,"type":20},182,[23],"This is a prospective, randomized, unblinded, multi-center study. Sites were selected from different geographies (EU and US) with different clinical practice to ensure the results are more generalizable.\n\nPrimary objective is to demonstrate that the average procedure fluoroscopy time using LumiGuide is lower compared to conventional fluoroscopy guidance in Fenestrated Endovascular Aortic Repair (FEVAR)",[26],"2026-06-11",{"date":95,"type":31},"2026-06-15",{"date":97,"type":31},"2025-07-03",{"date":99,"type":20},"2027-06-30",{"name":101,"class":79},"Philips Clinical & Medical Affairs Global",11,{"id":104,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":21,"phases":106,"briefSummary":24,"conditions":107,"keywords":4,"overallStatus":108,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":115,"locationsCount":39},"100639731",{"count":19,"type":20},[23],[26],"NOT_YET_RECRUITING","2026-05-21",{"date":111,"type":31},"2026-05-28",{"date":113,"type":20},"2026-07-15",{"date":35,"type":20},{"name":37,"class":38},{"id":117,"slug":118,"hasResults":12,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":12,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":123,"targetDuration":4,"studyType":21,"phases":125,"briefSummary":126,"conditions":127,"keywords":4,"overallStatus":108,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":4},"100622105","soft-foam-dressings-for-pressure-injury-prevention-of-cardiac-surgery-100622105","NCT07379294","Soft Foam Dressings for Pressure Injury Prevention of Cardiac Surgery","Effectiveness of Using Soft Foam Dressings in Preventing Pressure Injuries During Cardiac Surger","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Scheduled to undergo cardiac surgery under general anesthesia\n* Use of cardiopulmonary bypass (CPB) during surgery\n* Expected surgical duration greater than 4 hours\n* Intact skin without pre-existing pressure injury prior to surgery\n\nExclusion Criteria:\n\n* Surgical position other than supine\n* Long-term bedridden status prior to hospital admission\n* Altered consciousness or inability to cooperate\n* History of stroke with residual limb weakness",{"count":124,"type":20},80,[23],"The purpose of this study is to evaluate whether the application of soft foam dressings can reduce the occurrence of surgery-related pressure injuries among patients undergoing cardiac surgery. Specifically, this research aims to investigate differences in pressure injury outcomes before and after the intervention, and to assess the preventive effectiveness of soft foam dressings as an adjunctive skin-protection strategy.",[128,129,130,55,131,26,132,133,134],"CAD - Coronary Artery Disease","CABG","Valve Disease, Heart","Valve Heart Stenosis","Mitral Disease","AORTIC VALVE DISEASES","Aortic Dissection","2026-05-11",{"date":137,"type":31},"2026-05-14",{"date":139,"type":20},"2026-05-31",{"date":141,"type":20},"2027-05-30",{"name":143,"class":38},"Shih,Wen-Chi",{"id":145,"slug":146,"hasResults":12,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":150,"eligibilityCriteria":151,"healthyVolunteers":152,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":155,"phases":4,"briefSummary":156,"conditions":157,"keywords":159,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":39},"100538094","aortopathy-relationship-to-imagery-and-kinocardiography-features-artik-100538094","NCT06286358","Aortopathy Relationship To Imagery and Kinocardiography Features (ARTIK)","Impact of Aortic Valve Disease and Thoracic Aortic Aneurysm on Kinocardiographic Signals","ARTIK","Inclusion Criteria\n\n* \"Interventional treatment\" group\n\n  * Adults (\\>18 y)\n  * Interventional treatment indication for severe AVD and\u002For severe TAA, as decided by the Heart Team\n* \"Aortic valve disease of different severities\" group\n\n  * Adults (\\>18y)\n  * Aortic stenosis and\u002For aortic regurgitation and\u002For bicuspidy of different severities confirmed by echocardiography and\u002For cardiac MRI\n* \"Control\" group : - Adults (\\>18 y) appariated with the participants of other groups according to their age, sex, body surface area and LVEF\n\nExclusion Criteria:\n\n* Any severe rhythm disorder such as frequent ventricular extrasystoles, atrial tachyarrhythmias\n* Subject's disabilty to give consent\n* Subjects suffering from aortic valve disease or thoracic aortic aneurysm will be excluded from the \"control\" group.",true,{"count":154,"type":20},180,"OBSERVATIONAL","Kinocardiography (KCG) is a portable measurement technique developed to estimate cardiac mechanical performance by studying the vibrations produced by myocardial contraction during each heartbeat and transmitted to the body surface.\n\nThe goal of this observational study is to learn about kinocardiography in patients with aortic valve disease (AVD) or thoracic aortic aneurysm (TAA). The investigators believe that this technology will enable to diagnose aortic valve disease and aortic aneurysm.\n\nIn patients with AVD of different severities or TAA, the investigators will collect informations from echocardiography and\u002For cardiac magnetic resonance imaging, KCG recordings, phonocardiography (PCG) recordings, and video recordings. Researchers will also compare subjects without any AVD nor TAA to better understand these effects on KCG, PCG and video signal.",[158,26],"Aortic Valve Disease",[160,161,162,163],"Aortic stenosis","Aortic regurgitation","Thoracic aortic aneurysm","Kinocardiography","2026-04-27",{"date":166,"type":31},"2026-05-01",{"date":168,"type":31},"2024-03-07",{"date":170,"type":20},"2026-12-30",{"name":172,"class":38},"Université Libre de Bruxelles",{"id":174,"slug":175,"hasResults":12,"nctId":176,"briefTitle":177,"officialTitle":177,"acronym":178,"eligibilityCriteria":179,"healthyVolunteers":152,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":180,"targetDuration":182,"studyType":155,"phases":4,"briefSummary":183,"conditions":184,"keywords":188,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":39},"100232633","cardiovascular-health-improvement-project-100232633","NCT02306200","Cardiovascular Health Improvement Project","CHIP","Inclusion Criteria:\n\n* Any patient over the age of 18 who is able\u002Fwilling to give informed consent\n* Patients \\\u003C18 years of age with parental consent and assent (if assent is applicable for their age)\n* Diagnosis of:\n* aortic pathology potentially due to a known or suspected inherited condition\n* Idiopathic aortic aneurysm\n* Interesting of novel vascular pathology in the aorta or main branches\n* Family history of aortic or vascular disease\n* Other cardiovascular disease\n* Healthy controls with no apparent cardiovascular disease\n\nExclusion Criteria:\n\n\\- Not willing or able to sign the consent",{"count":181,"type":20},15000,"40 Years","The goal of this project is to establish a biobank of clinical information, DNA, plasma, and aortic tissue samples from patients with cardiovascular disease as well as healthy controls.",[26,134,185,186,187],"Bicuspid Aortic Valve (BAV)","Heart Failure","Cardiovascular Diseases",[189,190,191,185,134],"Aorta","Abdominal Aortic Aneurysm (AAA)","Thoracic Aortic Aneurysm (TAA)","2026-04-23",{"date":194,"type":31},"2026-04-29",{"date":196,"type":4},"2013-08",{"date":198,"type":20},"2053-08",{"name":200,"class":38},"University of Michigan",{"id":202,"slug":203,"hasResults":12,"nctId":204,"briefTitle":205,"officialTitle":205,"acronym":4,"eligibilityCriteria":206,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":207,"enrollmentInfo":208,"targetDuration":4,"studyType":21,"phases":209,"briefSummary":210,"conditions":211,"keywords":212,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":39},"100554652","safety-and-effectiveness-of-physician-modified-fenestrated-and-branched-aortic-endografting-for-the-treatment-of-thoracoabdominal-and-pararenal-aortic-aneurysms-100554652","NCT06501872","Safety and Effectiveness of Physician-Modified Fenestrated and Branched Aortic Endografting for the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms","Main Arm Inclusion Criteria:\n\n* Must be a man or woman 50 years of age or older by the date of informed consent\n* Must have a thoracoabdominal aortic aneurysm of any Crawford classification (extent I-V) that extends no more proximal than the left subclavian artery.\n* 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)\n* Must be considered, in the judgement of the Investigator, to be a high- risk candidate for open surgical repair\n* Must commit to comply with the five-year study assessment schedule of events\n* Must have a non-aneurysm-related life expectancy, in the judgement of the Investigator, of greater than 2 years\n\nExpanded Selection Inclusion Criteria:\n\n* Must be a man or woman 50 years of age or older by the date of informed consent\n* 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. The aneurysm must not extend proximal to the left subclavian artery, or, in the setting of more proximal disease, that disease must have been previously treated.\n* 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 Investigator, has aneurysm characteristics that portend a high risk of near-term rupture\n* In the setting of an aortic dissection the following criteria must exist:\n\n  * Access into the true lumen from the groin and at least one supra-aortic trunk vessel\n  * 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\n  * 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\n  * A true lumen size large enough to deploy the device and still gain access into the target branches\n* Must be considered, in the judgement of the Investigator, to be a high-risk candidate for open surgical repair\n* Patient must be able to provide informed consent\n* Must commit to comply with the five-year study assessment schedule of events\n* Must have a non-aneurysm-related life expectancy, in the judgement of the Investigator, of greater than 2 years\n\nMain Arm Exclusion Criteria:\n\n* Aneurysm due to acute or chronic dissection, intramural hematoma, penetrating aortic ulceration, pseudoaneurysm, mycotic aneurysm, or traumatic transection\n* Ruptured or acutely symptomatic aortic aneurysm\n* Known connective tissue disorder\n* 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\n* Known allergies to stainless steel, PTFE, polyester, polypropylene, nitinol, or gold\n* History of anaphylaxis to contrast, with inability to prophylax appropriately.\n* Have uncorrectable coagulopathy\n* Have unstable angina\n* Have a body habitus that would inhibit X-ray visualization of the aorta\n* Have a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned ≤30 days of the endovascular repair\n* Known to be participating in any other clinical study which may affect performance of this - Ability to bear children\n* Contraindication to oral antiplatelet therapy\n* Prisoners or those on alternative sentencing\n* Known systemic infection with potential for endovascular graft infection\n* Anticipated need for MRI scanning within 3 months of insertion of investigational product\n* Candidate for repair under the Instructions for Use of a commercially available, FDA-approved endovascular graft\n* 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.\n\nExpanded Selection Exclusion Criteria:\n\n* Known or suspected mycotic aneurysm\n* Ruptured aneurysm with hemodynamic instability\n* Known connective tissue disorder\n* 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\n* Known allergies to stainless steel, PTFE, polyester, polypropylene, nitinol, or gold\n* History of anaphylaxis to contrast, with inability to prophylax appropriately.\n* Have uncorrectable coagulopathy\n* Have a body habitus that would inhibit X-ray visualization of the aorta\n* Have a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned ≤ 30 days of the endovascular repair\n* Known to be participating in any other clinical study which may affect performance of this device\n* Ability to bear children\n* Contraindication to oral antiplatelet therapy\n* Prisoners or those on alternative sentencing\n* Known systemic infection with potential for endovascular graft infection\n* Anticipated need for MRI scanning within 3 months of insertion of investigational product\n* Candidate for repair under the Instructions for Use of a commercially available, FDA- approved endovascular graft\n* 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\n* Other conditions or comorbidities that, in the opinion of the Investigator, would exclude the patient","95 Years",{"count":124,"type":20},[23],"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.",[26],[26],"2026-04-13",{"date":215,"type":31},"2026-04-15",{"date":217,"type":31},"2024-12-10",{"date":219,"type":20},"2031-09",{"name":221,"class":38},"Bjoern D. Suckow",{"id":223,"slug":224,"hasResults":12,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":228,"eligibilityCriteria":229,"healthyVolunteers":12,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":230,"targetDuration":4,"studyType":21,"phases":232,"briefSummary":233,"conditions":234,"keywords":239,"overallStatus":108,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":252,"completionDateStruct":253,"leadSponsor":255,"locationsCount":39},"100633038","llm-based-intelligent-health-management-assistant-in-life-cycle-health-management-of-cardiac-surgery-patients-100633038","NCT07521488","LLM-Based Intelligent Health Management Assistant in Life-Cycle Health Management of Cardiac Surgery Patients","Application of Large Language Model-Based Intelligent Health Management Assistant in Life-Cycle Health Management of Patients After Cardiac Surgery: A Prospective Randomized Controlled Study","cFT-LLM","Inclusion Criteria:\n\n1. Aged 18 years or older, any sex\n2. Underwent cardiac surgery at the Department of Cardiac Surgery, Beijing Anzhen Hospital, Capital Medical University, including but not limited to: coronary artery bypass grafting (CABG), heart valve replacement or repair (aortic valve, mitral valve, or tricuspid valve surgery), great vessel surgery (aortic dissection or aortic aneurysm repair), congenital heart disease correction, or cardiac assist device implantation\n3. Clinically stable after surgery and eligible for hospital discharge\n4. Has access to a smartphone and is capable of independently operating a mobile application, or has a family member available to assist with operation\n5. Voluntarily participates in the study, understands and signs the informed consent form, and is able to comply with the study protocol requirements\n\nExclusion Criteria:\n\n1. Postoperative intensive care unit (ICU) stay exceeding 30 days, or presence of severe uncontrolled postoperative complications such as persistent infection or multi-organ failure\n2. Life expectancy less than 12 months due to advanced malignancy or end-stage organ failure\n3. Severe cognitive impairment, psychiatric disorder, or inability to understand and use a mobile application without available caregiver assistance\n4. Heart transplant recipient\n5. Currently participating in another interventional clinical study\n6. Anticipated inability to complete 12-month follow-up",{"count":231,"type":20},500,[23],"This is a single-center, prospective, randomized, open-label, parallel-controlled clinical study to evaluate the effectiveness of a large language model (LLM)-based intelligent health management assistant in the life-cycle health management of patients after cardiac surgery. A total of 500 adult patients who undergo cardiac surgery (including coronary artery bypass grafting, heart valve surgery, great vessel surgery, congenital heart disease correction, and other cardiac procedures) at Beijing Anzhen Hospital will be randomly assigned in a 1:1 ratio to an intervention group or a control group, stratified by age (\\\u003C65 vs ≥65 years) and surgery type. The intervention group will use the LLM-based mobile health management application in addition to standard postoperative care, while the control group will receive standard postoperative care alone. The application integrates multimodal clinical data into a personalized health profile and provides surgery-type-specific postoperative management recommendations, medication adherence reminders, complication early warning, and cardiac rehabilitation guidance. The primary outcome is the composite endpoint of major adverse cardiac and cerebrovascular events (MACCE), defined as all-cause death, non-fatal myocardial infarction, non-fatal stroke, or unplanned cardiovascular reoperation\u002Freintervention, within 12 months after randomization. Secondary outcomes include health-related quality of life (EQ-5D-5L), cardiovascular rehospitalization rate, medication adherence (MMAS-8), postoperative complication rate, and cardiac rehabilitation achievement rate. Follow-up visits are scheduled at 1, 3, 6, 9, and 12 months post-randomization.",[235,236,26,134,237,238],"Coronary Artery Bypass Grafting","Heart Valve Disease","Congenital Heart Disease","Cardiac Surgical Procedures",[240,241,242,243,244,245,246,247,248,249],"Large Language Model","Artificial Intelligence","Cardiac Surgery","Postoperative Health Management","Digital Health","Medication Adherence","Cardiac Rehabilitation","MACCE","Mobile Health Application","Personalized Health Management","2026-04-08",{"date":213,"type":31},{"date":166,"type":20},{"date":254,"type":20},"2027-12-31",{"name":256,"class":38},"Beijing Anzhen Hospital",{"id":258,"slug":259,"hasResults":12,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":263,"eligibilityCriteria":264,"healthyVolunteers":152,"sex":16,"minAge":265,"maxAge":4,"enrollmentInfo":266,"targetDuration":4,"studyType":155,"phases":4,"briefSummary":268,"conditions":269,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":275,"completionDateStruct":276,"leadSponsor":278,"locationsCount":280},"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","22 Years",{"count":267,"type":20},250,"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.",[26,270,54,271],"Aortic Aneurysm Abdominal","Aortic Aneurysm, Thoracoabdominal","2026-03-31",{"date":274,"type":31},"2026-04-06",{"date":272,"type":31},{"date":277,"type":20},"2026-09-05",{"name":279,"class":79},"Aiatella Oy",3,{"id":282,"slug":283,"hasResults":12,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":4,"eligibilityCriteria":287,"healthyVolunteers":12,"sex":16,"minAge":48,"maxAge":288,"enrollmentInfo":289,"targetDuration":4,"studyType":21,"phases":291,"briefSummary":292,"conditions":293,"keywords":294,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":300,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":306,"locationsCount":39},"100527381","utilizing-3d-printed-personalized-aortic-lesion-models-in-preoperative-assessment-100527381","NCT06147024","Utilizing 3D Printed Personalized Aortic Lesion Models in Preoperative Assessment","Utilizing 3D Printed Personalized Aortic Lesion Models to Assist Surgeons in Preoperative Assessment and Planning of Aortic Aneurysm Surgery","Inclusion Criteria:\n\n* Diagnosed with thoracic or abdominal aortic aneurysm\n* Signed surgical consent\n* Non-emergent surgery\n* Had 2D CT imaging within the last 6 months\n\nExclusion Criteria:\n\n* Refusal to use lesion images for model creation\n* Refusal to participate in the study","80 Years",{"count":290,"type":20},10,[23],"Using 3D printing technology to create personalized models of diseased heart and aortic blood vessels, surgeons can perform preoperative planning and evaluate relevant indicators.",[26],[295,296,297,298],"3D printing","pre-operative planning","thoracic aorta aneurysm","abdominal aorta aneurysm","2026-02-25",{"date":301,"type":31},"2026-02-27",{"date":303,"type":31},"2024-04-08",{"date":305,"type":20},"2027-07-31",{"name":307,"class":38},"Fu Jen Catholic University",{"id":309,"slug":310,"hasResults":12,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":4,"eligibilityCriteria":314,"healthyVolunteers":152,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":315,"targetDuration":4,"studyType":155,"phases":4,"briefSummary":316,"conditions":317,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":319,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":324,"locationsCount":39},"100625399","multidisciplinary-analysis-by-morphological-and-mechanical-evaluation-of-the-aortic-wall-in-patients-undergoing-cardiac-surgery-100625399","NCT07422129","Multidisciplinary Analysis by Morphological and Mechanical Evaluation of the Aortic Wall in Patients Undergoing Cardiac Surgery.","Multidisciplinary Analysis by Morphological and Mechanical Evaluation of the Aortic Wall in Patients With Aortic Disease, Undergoing Aortic Cardiac Surgery, vs Patients Without Aortic Disease","Inclusion Criteria:\n\n* Patients undergoing surgery including ascending aorta replacement at our Department and\u002For heart transplantation\n\nExclusion Criteria:\n\n* Patients with biological hazard (HBC\u002FHIV +)",{"count":267,"type":20},"Surgical indication in patients suffering from Ascending aorta aneurysm is currently based mainly on the maximum diameter of the aortic dilatation and on the yearly growth rate. Several clinical preoperative patients characteristics have been, potentially, correlated to impaired mechanical characteristics of aortic wall, and therefore to an increased risk of rupture and or dissection. On other hands, such suppositions have been never confirmed, as a full characterization of the mechanical behaviour of the ascending aortic tissue, especially in case of aneurysm, has not been fully clarified yet. Objective of this observational study is to better elucidate, using direct in vivo evaluation, the mechanical characteristics of the aortic wall in patients with ascending aorta diseases. Our study will have a further peculiar characteristic as we have the intention of compare such mechanical characteristics to those of patients, without known aortic diseases, undergoing heart transplantation. Potential correlation between, directly measured mechanical characteristics of the aortic wall, and preoperative parameters (anagraphic patients characteristics, clinical data and diagnostic tests) will be also investigated.",[26,54],"2026-02-12",{"date":320,"type":31},"2026-02-19",{"date":322,"type":31},"2015-03-24",{"date":254,"type":20},{"name":325,"class":38},"Fondazione IRCCS Policlinico San Matteo di Pavia",{"id":327,"slug":328,"hasResults":12,"nctId":329,"briefTitle":330,"officialTitle":330,"acronym":331,"eligibilityCriteria":332,"healthyVolunteers":152,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":333,"targetDuration":335,"studyType":155,"phases":4,"briefSummary":336,"conditions":337,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":338,"lastUpdatePostDateStruct":339,"startDateStruct":341,"completionDateStruct":343,"leadSponsor":345,"locationsCount":19},"100362959","montalcino-aortic-consortium-precision-medicine-for-heritable-thoracic-aortic-disease-100362959","NCT04005976","Montalcino Aortic Consortium: Precision Medicine for Heritable Thoracic Aortic Disease","MAC:H-TAD","Inclusion Criteria:\n\n* Patients and their relatives with a confirmed pathogenic, likely pathogenic variant, or variant of unknown clinical significance in at least one of the H-TAD genes (i.e. TGFBR1, TGFBR2, SMAD3, TGFB2, TGFB3, ACTA2, MYH11, MYLK, PRKG1, MAT2A, MFAP5, LOX, COL3A1, FOXE3, and FBN1).\n* Patients of all ages, sex and race for which informed consent can be obtained.\n\nExclusion Criteria:\n\n* Patients without a confirmed causative variant for H-TAD.",{"count":334,"type":20},5000,"20 Years","The Montalcino Aortic Consortium (MAC) will provide the infrastructure to assemble large cohorts of patients with mutations in known heritable thoracic aortic disease (H-TAD) genes, define the phenotype associated with these genes, and determine genetic and environmental modifiers of H-TAD.",[26,134,55],"2026-01-29",{"date":340,"type":31},"2026-02-02",{"date":342,"type":31},"2016-06-15",{"date":344,"type":20},"2037-01-01",{"name":346,"class":38},"The University of Texas Health Science Center, Houston",{"id":348,"slug":349,"hasResults":12,"nctId":350,"briefTitle":351,"officialTitle":351,"acronym":4,"eligibilityCriteria":352,"healthyVolunteers":152,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":353,"targetDuration":4,"studyType":21,"phases":355,"briefSummary":356,"conditions":357,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":358,"lastUpdatePostDateStruct":359,"startDateStruct":361,"completionDateStruct":363,"leadSponsor":365,"locationsCount":39},"100576785","exercise-physiology-in-patients-with-aortic-aneurysm-and-its-correlation-with-mechanical-properties-of-aortic-tissue-100576785","NCT06789809","Exercise Physiology in Patients With Aortic Aneurysm and Its Correlation With Mechanical Properties of Aortic Tissue","Inclusion Criteria:\n\n1. Healthy controls for baseline comparison\n\n   1. Must be 18 years or older\n   2. No history of cardiovascular disease, neither hypertension, diabetes nor hypercholesterolemia\n2. Aneurysm patients who have not yet been operated on but are currently being monitored\n\n   1. Must be 18 years or older\n   2. No history of operation for aortic aneurysm\n3. Pre-operative aneurysm patients: imaged pre-operatively and 12 months\n\n   1. Patients admitted at the CCF cardiothoracic services for elective surgery due to aortic aneurysms\n   2. Must be 18 years or older\n\nExclusion Criteria:\n\nFor all patients:\n\n* Contra-indication for MRI\n\n  * Heart pacemaker\u002Fdefibrillator.\n  * Electronic\u002Fimplanted stimulators or devices, including deep brain stimulator, vagus nerve stimulator, bladder stimulator, spine stimulator, neurostimulators; implanted electrodes or wires.\n  * Cochlear implant or other ear implants.\n  * Implanted drug pumps (insulin, narcotic\u002Fpain medications, drugs to treat spasticity).\n  * Programmable shunt.\n  * Aneurysm clips and coils.\n  * Stents (not located in heart).\n  * Filters (for example, blood clot filters).\n  * Metal fragment in your body or eye (eg, BBs, bullets, shrapnel, metal pieces or shavings).\n* Congenital heart diseases such as patent ductus arteriosus, coarctation of aorta, ASD and VSD\n* Presence of A-V fistula or intracardiac shunts\n* Moderate or severe dysfunction in multiple valves\n* Patients with significant claustrophobia\n* Patients unable to pedal a supine bicycle\n* Those who require supplemental oxygen\n\nSpecific Exclusion Criteria:\n\n1. Healthy controls for baseline comparison\n\n   1. Excluded if using cardioprotective medication\n   2. Have a bicuspid aortic valve diagnosed using MRI\n2. Pre-operative aneurysm patients: imaged pre-operatively and at 12 months a. Patients with traumatic aortic rupture",{"count":354,"type":20},35,[23],"Aortic aneurysm patients benefit from exercise yet patients and physicians do not know a safe level. Cardiac MRI (CMR) is the most comprehensive imaging modality for phenotypic evaluation of patients with cardiac disease but it has not been used to study aneurysm patients. The purpose of this project is use exercise CMR to understand regional aortic function and quantify aortic elasticity in these populations while exercising. This project will correlate the exercise CMR data with the biomechanical properties of the patient's aortic tissue, including epiaortic ultrasound and TEE performed during aortic repair, and explanted aortic specimens subjected to ex vivo uniaxial tensile testing. Correlating this data with aortic response to exercise will allow us to understand how aortic size, in vivo circumferential strain values, ex vivo aortic efficiency and mechanical failure all relate to exercise physiology.",[26],"2025-12-28",{"date":360,"type":31},"2026-01-02",{"date":362,"type":31},"2023-11-23",{"date":364,"type":20},"2029-03-31",{"name":366,"class":38},"The Cleveland Clinic",{"id":368,"slug":369,"hasResults":12,"nctId":370,"briefTitle":371,"officialTitle":372,"acronym":373,"eligibilityCriteria":374,"healthyVolunteers":12,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":375,"targetDuration":4,"studyType":155,"phases":4,"briefSummary":376,"conditions":377,"keywords":4,"overallStatus":108,"whyStopped":4,"lastUpdateSubmitDate":378,"lastUpdatePostDateStruct":379,"startDateStruct":380,"completionDateStruct":382,"leadSponsor":384,"locationsCount":4},"100615633","bentley-bridging-stent-graft-study-100615633","NCT07295145","Bentley Bridging Stent Graft Study","BeFab: An International, Multi-centre Observational Study to Evaluate Safety, Performance, and Clinical Benefit of Bentley Bridging Stent Graft Systems","BeFab","Inclusion Criteria:\n\n* Adult patients having complex abdominal aortic aneurysms suitable for an endovascular repair with a fenestrated and\u002For branched aortic endovascular graft in combination with one Bentley bridging stent graft per reno-visceral artery in accordance with the IFU of BeFlared, BeGraft or BeGraft Plus. Use of different products for different target vessels is allowed. Use of stents from other manufacturers for other reno-visceral arteries is allowed.\n* Patient is capable and willing to sign the informed consent and agrees to fulfil follow-up requirements\n* Patients ≥18 years of age at the time of consent\n\nExclusion Criteria:\n\n* Patients with contraindications as listed in the IFUs\n* Previous stenting of the target vessel\n* Extension\u002Frelining of Bentley BSGs\n* Prior EVAR procedure",{"count":50,"type":20},"This international, observational multi-centre observational study of the devices BeFlared FEVAR Stent Graft System (BeFlared), BeGraft Stent Graft System (BeGraft), and BeGraft Plus Stent Graft System (BeGraft Plus) will monitor technical success of the implantation, data regarding clinical performance, clinical benefit, as well as potential unknown side effects for the use as bridging stent grafts in combination with fenestrated aortic endovascular grafts.",[26],"2025-12-16",{"date":74,"type":31},{"date":381,"type":20},"2026-01",{"date":383,"type":20},"2031-12",{"name":385,"class":79},"Bentley InnoMed GmbH",{"id":387,"slug":388,"hasResults":12,"nctId":389,"briefTitle":390,"officialTitle":391,"acronym":392,"eligibilityCriteria":393,"healthyVolunteers":12,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":394,"targetDuration":4,"studyType":21,"phases":396,"briefSummary":397,"conditions":398,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":401,"lastUpdatePostDateStruct":402,"startDateStruct":404,"completionDateStruct":406,"leadSponsor":408,"locationsCount":410},"100398727","nexus-aortic-arch-clinical-study-to-evaluate-safety-and-effectiveness-100398727","NCT04471909","NEXUS Aortic Arch Clinical Study to Evaluate Safety and Effectiveness","A Multi-arm, Multi-Center, Non-Randomized, Prospective, Clinical Study to Evaluate the Safety and Effectiveness of the NEXUS Aortic Arch Stent Graft System in Treating Thoracic Aortic Lesions Involving the Aortic Arch","TRIOMPHE","Inclusion Criteria:\n\n1. Male and female age ≥ 18.\n2. Proximal\u002Fascending native or previously implanted surgical graft landing zone of appropriate length\n3. Proximal\u002Fascending native or previously implanted surgical graft landing zone of appropriate diameter\n4. Distal\u002Fdescending native landing zone of appropriate length\n5. Distal\u002Fdescending native landing zone of appropriate diameter\n6. Brachiocephalic trunk native landing zone of appropriate length\n7. Brachiocephalic trunk native landing zone of appropriate diameter\n8. Appropriate take off angle between the Brachiocephalic Artery and the Aortic Arch perpendicular\n9. Appropriate aortic arch perpendicular diameter\n10. Chronic dissection with at least one of the following conditions:\n\n    1. An aortic aneurysm with a maximum diameter ≥ 55 mm\n    2. Rapidly expanding false lumen (growth of \\> 0.5 cm\u002F6 months)\n    3. Compressed true lumen associated with end organ malperfusion\n    4. Symptomatic\n11. Aneurysm with at least one of the following conditions:\n\n    1. Dilatation of the aortic arch larger than 5 cm in diameter for subject with fusiform aneurysm\n    2. Dilatation of the aortic arch is 1.5 times the normal diameter for subjects ascending or descending\n    3. Dilation of the aortic arch larger than 2.5 cm for subject with saccular aneurysm\n    4. Symptomatic aneurysm of the aortic arch\n    5. Aortic diameter growth rate \\> 5mm per 6 months\n    6. Postoperative pseudoaneurysm expanding from anastomotic suture lines\n12. Penetrating aortic ulcer with at least one of the following:\n\n    1. Symptomatic\n    2. Ulcer demonstrates expansion\n13. Intramural hematoma with at least one of the following:\n\n    1. Symptomatic (persistent pain)\n    2. Transverse or longitudinal expansion on serial imaging\n14. In the event of a lesion in the ascending aortic, the proximal\u002Fascending native or previously implanted surgical graft the landing zone must be appropriate\n15. Femoral \u002F iliac artery diameter as documented by CTA or MRA that allows endovascular access to the diseased site with a 20 Fr. delivery catheter.\n16. Access vessels morphology suitable for endovascular repair in terms of tortuosity, calcification and angulation, documented by CTA\u002FMRA.\n17. Brachial\u002FAxial Artery diameter that allows endovascular access suitable for 7 Fr.\n18. Subject is considered an appropriate candidate for an elective surgery.\n19. Subject is considered to be at high risk for open repair, as determined by the investigator.\n20. Access vessels, iliac\u002Ffemoral \\& brachial\u002Faxillary compatible with vascular access techniques (femoral cutdown or percutaneous), devices, and \u002For accessories.\n21. Subject is willing and able to comply with procedures specified in the protocol and is able to return for follow-up visits as specified by the protocol.\n\nExclusion Criteria:\n\n1. Acute dissection\n2. Lesions that can be safely treated with TEVAR landing in zone 2 (with or w\u002Fo LSA vascularization)\n3. Required emergent treatment, e.g., trauma, rupture\n4. Acute vascular injury of the aorta due to trauma\n5. Aortic rupture or unstable aneurysm\n6. Received a previous stent or stent graft in the treated area (including planned landing area)\n7. Required surgical or endovascular treatment of an infra-renal aneurysm at time of implantation\n8. Planned major surgical or interventional procedure at time of screening, to be performed after the NEXUS™ implantation.\n9. Any major surgical or interventional procedure 6 weeks before the NEXUS™ implantation, exclusive of planned procedures that are needed for the safe and effective placement of the stent graft (e.g. supra-aortic bypass).\n10. Subject has had a myocardial infarction (MI) or cerebral vascular accident (CVA) within 90 days prior to the planned implantation\n11. Subjects with severe aortic valvular insufficiency as determined by echocardiography\n12. Mechanical valve that preclude safe delivery of NEXUS™\n13. Known Connective tissue disease (e.g., Marfan's or Ehler's-Danlos syndromes)\n14. Subject has an active systemic infection at the time of the procedure documented by pain, fever, drainage, positive culture\n15. Pregnant\n16. Life expectancy of less than 2 years\n17. Unsuitable vascular anatomy\n18. Subject who have a previously implanted surgical wrap of the ascending aorta\n19. Any medical condition that, according to the investigator's decision, might expose the subject to increased risk by the investigational device or procedure.\n20. An aneurysm that is mycotic, inflammatory or suspected to be infected.\n21. Subject with hostile groins\u002Faxilla (scarring, obesity, or previous failed puncture) unless conduit are used.\n22. Subjects with severe atherosclerosis, severe calcification or extensive intraluminal thrombus of the aorta or in the brachiocephalic trunk\n23. Subject is suffering from unstable angina or NYHA classification III and IV.\n24. Subject has a known hypersensitivity or contraindication to anticoagulants, antiplatelets, or contrast media, which is not amenable to pre-treatment.\n25. Subject with a contraindication to undergo angiography\n26. Subject with known sensitivities or allergies to the device materials (including Nitinol \\[NiTi\\], polyester fabric \\[PET\\], tantalum \\[TA\\])\n27. Clinical conditions that severely inhibit x-ray visualization of the Aorta.\n28. Subject has history of bleeding diathesis or coagulopathy that may limit the use of dual antiplatelet or anticoagulant therapy by the decision of the investigator\n29. Acute renal failure; chronic renal failure (excluding dialysis); Creatinine \\> 2.00 mg\u002Fdl\n30. Any other medical, social, or psychological issues that in the opinion of the investigator preclude them from receiving this treatment, or the procedures and evaluations pre- and post- treatment.\n31. Active participation in another clinical study that has not completed primary endpoint(s) evaluation or that clinically interferes with the endpoints in this study, or subject is planning to participate in such study prior to the completion of this study.",{"count":395,"type":20},110,[23],"Prospective, non-randomized, multi-center clinical investigation of the NEXUS™ Aortic Arch Stent Graft System (NEXUSTM) for the treatment of thoracic aortic lesions involving the aortic arch with a proximal landing zone, native or previously implanted surgical graft, in the ascending aorta and with a brachiocephalic trunk native landing zone.",[134,26,399,400],"Intramural Hematoma","Penetrating Aortic Ulcer","2025-10-16",{"date":403,"type":31},"2025-10-20",{"date":405,"type":31},"2020-10-20",{"date":407,"type":20},"2029-10",{"name":409,"class":79},"Endospan Ltd.",32,{"id":412,"slug":413,"hasResults":12,"nctId":414,"briefTitle":415,"officialTitle":415,"acronym":4,"eligibilityCriteria":416,"healthyVolunteers":12,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":417,"targetDuration":4,"studyType":21,"phases":419,"briefSummary":420,"conditions":421,"keywords":424,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":429,"lastUpdatePostDateStruct":430,"startDateStruct":432,"completionDateStruct":434,"leadSponsor":436,"locationsCount":39},"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":418,"type":20},15,[23],"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.",[422,423,26],"Juxta Renal Abdominal Aortic Aneurysm Without Rupture","Complex Aortic Aneurysms",[425,426,427,428],"Physician Modified Endograft","PMEG","Complex aortic aneurysms","Juxta renal aortic aneurysm","2025-08-19",{"date":431,"type":31},"2025-08-24",{"date":433,"type":31},"2025-06-01",{"date":435,"type":20},"2032-05-01",{"name":437,"class":38},"Akhilesh Jain",{"id":439,"slug":440,"hasResults":12,"nctId":441,"briefTitle":442,"officialTitle":443,"acronym":4,"eligibilityCriteria":444,"healthyVolunteers":152,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":445,"targetDuration":4,"studyType":155,"phases":4,"briefSummary":446,"conditions":447,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":449,"lastUpdatePostDateStruct":450,"startDateStruct":452,"completionDateStruct":453,"leadSponsor":455,"locationsCount":39},"100574690","prophylactic-mesh-reinforcement-after-open-aortic-aneurysm-repair-100574690","NCT06762561","Prophylactic Mesh Reinforcement After Open Aortic Aneurysm Repair","Prophylactic Mesh Reinforcement After Open Aortic Aneurysm Repair: a Retrospective Study","Inclusion Criteria:\n\n* Adult patients (≥18 years old) who underwent open abdominal aortic aneurysm (AAA) repair with prophylactic retromuscular mesh reinforcement between January 2019 and January 2024\n* Availability of complete medical records, including preoperative history, surgical details, and postoperative follow-up data\n* Attendance at a clinical follow-up examination at least one year after the procedure\n* General informed consent signed for the use of medical data for research purposes\n\nExclusion Criteria:\n\n* Patients with incomplete or missing medical records, including preoperative, intraoperative, or follow-up data\n* Patients who required a re-laparotomy involving incision or suture of the prophylactic mesh and subsequently developed an incisional hernia.\n* Patients who did not attend the required clinical follow-up examination at least one year postoperatively.",{"count":19,"type":20},"The goal of this retrospective observational study is to evaluate whether prophylactic mesh reinforcement during abdominal wall closure can prevent incisional hernias (IH) in patients undergoing open abdominal aortic aneurysm (AAA) repair. The main questions it aims to answer are:\n\n* Does mesh reinforcement reduce the incidence of incisional hernias?\n* What is the frequency of associated postoperative complications? Researchers will compare the outcomes of patients who underwent mesh-reinforced closures to literature-reported outcomes for non-mesh cases to assess differences in IH incidence and complications.\n\nParticipants will:\n\n* Undergo clinical follow-ups and abdominal ultrasounds to detect IH.\n* Complete quality-of-life questionnaires (EQ-5D and PROMIS).",[448,26],"Incisional Hernia","2025-06-02",{"date":451,"type":31},"2025-06-03",{"date":433,"type":20},{"date":454,"type":20},"2026-10-31",{"name":456,"class":38},"Hôpital Fribourgeois",{"id":458,"slug":459,"hasResults":12,"nctId":460,"briefTitle":461,"officialTitle":462,"acronym":463,"eligibilityCriteria":464,"healthyVolunteers":12,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":465,"targetDuration":4,"studyType":21,"phases":467,"briefSummary":468,"conditions":469,"keywords":482,"overallStatus":108,"whyStopped":4,"lastUpdateSubmitDate":488,"lastUpdatePostDateStruct":489,"startDateStruct":491,"completionDateStruct":493,"leadSponsor":494,"locationsCount":496},"100586678","prophylactic-suture-line-sealing-with-nex-glue-r-eco-in-cardiac-and-vascular-surgery-100586678","NCT06918496","Prophylactic Suture Line Sealing With NE'X Glue R-eco in Cardiac and Vascular Surgery","A Prospective ClinicaL investigatiOn Evaluating Prophylactic Sealing of sUture Lines Using the NE'X Glue R-eco Surgical AdhesivE in Cardiac and (Cardio)Vascular Anastomotic Repair Procedures","CLOSURE","Inclusion Criteria:\n\n* Patient ≥ 18 years of age at study entry.\n* Patient is scheduled for open procedures for surgical placement of a prosthetic or biologic graft (patch) or an allograft for cardiac and (cardio)vascular anastomosis repair. Emergency, transplantation and minimally invasive procedures are excluded. Patients receiving long-term anticoagulation, including antiplatelet agent, are included. Choice of graft is at the discretion of the surgeon.\n* Patient is willing and able to be contacted for up to 3 months (± 14 days) follow-up.\n* Patient or legal representative and investigator signed and dated the informed consent form prior to the index-procedure.\n\nExclusion Criteria:\n\n* Patient has a known hypersensitivity, contraindication, or allergic reaction to albumin or glutaraldehyde.\n* Patient has a history of bleeding diathesis or coagulopathy.\n* Presence of active infection or contamination in the to be grafted area or the vicinity.\n* Known vasculitis in the to be grafted area.\n* Patient takes immune suppressive medication like prednisone resulting in weakening of the vessel wall.\n* Patient is refusing blood transfusion.\n* Patient or legal representative is unable \u002F unwilling to provide informed consent.\n* Patient is unable to comply with the protocol or proposed follow-up visits.\n* Female patient is pregnant, lactating, or planning pregnancy during the clinical investigation.\n* Female participants of childbearing age must agree to use safe contraception (e.g., intrauterine devices, hormonal contraceptives: contraceptive pills, implants, transdermal patches hormonal vaginal devices, injections with prolonged release, abstinence).\n* Patients who are currently enrolled in another clinical study, or have recently participated in a clinical study, that could potentially interfere with the outcomes or introduce bias into the results of the current study (as determined by the investigator). This includes studies involving investigational drugs, medical devices, or other interventions that could impact the safety, efficacy, or scientific integrity of this study.",{"count":466,"type":20},60,[23],"This clinical study aims to evaluate the effectiveness and safety of using NE'X Glue R-eco to seal suture lines. The adhesive will be applied to reduce the risk of suture line bleeding in cardiac or vascular repair surgeries, a prosthetic or biologic graft, patch, or allograft.\n\nThe effectiveness of the adhesive will be assessed after restoring blood flow.",[26,270,470,471,472,473,474,475,476,477,478,479,480,481],"Valve Stenoses, Aortic","Valve Regurgitation, Mitral","Valve Regurgitation, Tricuspid","Aneurysm of Ascending Aorta","Aneurysm Abdominal","Artery Diseases, Peripheral","Ventricular Aneurysm","Coronary Artery Disease","Valve Aortic Regurgitation","Aortic Aneurysms Arch","Aortic Aneurysms Descending","Aortic Aneurysms Thoracoabdominal",[483,484,485,486,487],"prophylactic sealing of suture lines","Surgical glue","cardiac and (cardio)vascular anastomotic repair procedures","grafts","NE'X Glue R-eco surgical adhesive","2025-04-08",{"date":490,"type":31},"2025-04-09",{"date":492,"type":20},"2025-06-30",{"date":272,"type":20},{"name":495,"class":79},"Grena Biomed Limited",2,{"id":498,"slug":499,"hasResults":12,"nctId":500,"briefTitle":501,"officialTitle":501,"acronym":4,"eligibilityCriteria":502,"healthyVolunteers":12,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":503,"targetDuration":4,"studyType":155,"phases":4,"briefSummary":505,"conditions":506,"keywords":509,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":488,"lastUpdatePostDateStruct":516,"startDateStruct":518,"completionDateStruct":520,"leadSponsor":522,"locationsCount":39},"100498798","qol-after-complex-endovascular-aortic-repair-100498798","NCT05774938","QoL After Complex Endovascular Aortic Repair","Inclusion Criteria:\n\n* Men and women.\n* Any age (≥18 years)\n* Planned (elective) endovascular treatment by EVAR, FEVAR or BEVAR.\n* Patients previously treated by EVAR which are planned for an adjunct fenestrated cuff will not be included in the basic analysis, but included and analysed separately.\n\nExclusion Criteria:\n\n* Inability to understand and\u002For respond to the study questionnaires that are in Swedish.\n* Inability to provide an informed consent for participation in the study, orally or in writing (This may be due to linguistic or cognitive limitation).\n* Participation in other ongoing studies concerning quality of life.",{"count":504,"type":20},90,"The goal of this prospective observational cohort study is to compare health related quality of life in patients with abdominal aortic aneurysms treated by either standard or complex EVAR (endovascular aneurysm repair) devices. The main questions it aims to answer are:\n\n* Compare differences between the physical scores from the preoperative to the postoperative settings between patients treated with standard EVAR vs non-standard endovascular aortic repair (F-\u002FBEVAR)\n* To compare long-term physical scores postoperatively between patients treated with standard EVAR vs non-standard endovascular aortic repair (F-\u002FBEVAR) at one year.\n* To explore at which time points (if ever) patients treated with standard-EVAR and nonstandard endovascular aortic repair (F-\u002FBEVAR) have restored or normalized physical scores measured by SF-12, measured at 30 days, 6 months, 1 and 3 years.\n\nParticipants will be asked to fill out forms pre- and postoperatively with regards to health related quality of life.\n\nThe different groups for comparison will be either standard EVAR for infrarenal aortic aneurysms or complex EVAR (fenestrated or branched) for paravisceral aortic aneurysms (PVAAA).",[507,26,508],"Quality of Life","Aortic Aneurysm, Abdominal",[510,511,512,513,514,515],"Endovascular aneurysm repair","Pararenal aortic aneurysm","Quality of life","Paravisceral aortic aneurysm","Fenestrated endovascular aortic repair","Branched endovascular aortic repair",{"date":517,"type":31},"2025-04-10",{"date":519,"type":31},"2023-02-28",{"date":521,"type":20},"2030-01",{"name":523,"class":38},"Karolinska University Hospital",{"id":525,"slug":526,"hasResults":12,"nctId":527,"briefTitle":528,"officialTitle":529,"acronym":530,"eligibilityCriteria":531,"healthyVolunteers":12,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":532,"targetDuration":4,"studyType":21,"phases":533,"briefSummary":534,"conditions":535,"keywords":537,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":539,"lastUpdatePostDateStruct":540,"startDateStruct":542,"completionDateStruct":544,"leadSponsor":546,"locationsCount":39},"100547747","laser-in-situ-fenestration-study-100547747","NCT06411990","Laser In Situ Fenestration Study","Laser In Situ Fenestration for Endovascular Aortic Repair (LIFE) Study","LIFE","Inclusion Criteria:\n\n1. Aortic aneurysm \\>5.5 cm in a man or \\> 5.0 cm in a woman or rapid expansion deemed at significant risk for rupture in the juxtarenal or pararenal aorta.\n2. Endovascular aortic repair requiring coverage of renovisceral branches.\n3. Not candidate or at high risk for open repair. For example, but not exclusively, due to renal dysfunction, previous abdominal surgery, obese body habitus, previous coronary bypass grafts or high cardiac risk, chronic obstructive pulmonary disease (COPD) or on oxygen at rest, poorly controlled diabetes, current smoking, or antiplatelet or anticoagulation use.\n4. Proximal aortic landing zone in Zone 5 of the aorta or previous graft of at least 10 mm in length and diameter of between 20 and 40 mm.\n5. Distance ≥ 5 mm between top of graft fabric and renovisceral branch orifice.\n6. At least a 5 mm iliofemoral artery to accept the endovascular stent graft device and an axillary brachial artery of sufficient diameter to accept the laser catheter.\n7. Renovisceral diameter between 4 and 13 mm at the origin.\n8. At the time of case planning, the patient's anatomy appears amenable to complete exclusion of the aneurysm with laser fenestration techniques.\n9. Not willing or able to travel to sites that have access to manufacturer-made investigational endovascular devices.\n10. Not a candidate for currently approved endovascular options.\n11. 18 years or older.\n12. Patient or legally authorized representative agrees to participate in the study and provides written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization.\n13. Patient is able and willing to meet all study requirements, including participating in follow up evaluations and attending required assessment visits.\n\nExclusion Criteria:\n\n1. Known sensitivities or allergies to the materials of construction of the devices, including Nitinol, polyester, Platinum-Iridium, stainless steel, fluoropolymer, and heparin.\n2. Known hypersensitivity or contraindication to anticoagulation or contrast media that cannot be adequately medically managed.\n3. Uncorrectable coagulopathy.\n4. Body habitus that would inhibit radiographic visualization of the aorta or exceeds the safe capacity of equipment.\n5. Concurrent participation in another research protocol for investigation of an experimental therapy.\n6. Subject has been judged to be unsuitable for participation in the study by the Investigator for any reason.",{"count":418,"type":20},[23],"The goal of this clinical trial is to learn about a new device, named the LIFE device, to treat people with aneurysms (swellings) in the aorta (large, main blood vessel that delivers blood from the heart to the body). The main questions this trial aims to answer are:\n\n* If the LIFE device works to treat aortic aneurysms\n* What medical problems participants have when the LIFE device is used Participants will undergo treatment with the LIFE device and thereafter at 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years have their pulses checked, bloodwork to check kidney function (BUN and serum creatinine), and a CT scan of the aneurysm area.",[26,536],"Endovascular Aneurysm Repair",[538],"Fenestrated Endovascular Aneurysm Repair","2025-03-24",{"date":541,"type":31},"2025-03-28",{"date":543,"type":31},"2024-10-15",{"date":545,"type":20},"2031-06",{"name":547,"class":38},"Jonathan Bath",{"id":549,"slug":550,"hasResults":12,"nctId":551,"briefTitle":552,"officialTitle":552,"acronym":553,"eligibilityCriteria":554,"healthyVolunteers":12,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":555,"targetDuration":4,"studyType":21,"phases":556,"briefSummary":557,"conditions":558,"keywords":559,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":565,"lastUpdatePostDateStruct":566,"startDateStruct":568,"completionDateStruct":570,"leadSponsor":572,"locationsCount":39},"100322681","patient-specific-biomechanical-modeling-of-abdominal-aortic-aneurysm-to-improve-aortic-endovascular-repair-100322681","NCT03481075","Patient Specific Biomechanical Modeling of Abdominal Aortic Aneurysm to Improve Aortic Endovascular Repair","AAA2D3DIII","Inclusion Criteria:\n\n* Patients with a clinical indication for EVAR\u002FFEVAR of AAA and meeting anatomic inclusion criteria on preoperative enhanced CT-scan compatible with an endovascular repair.\n* Willing and capable of providing informed consent\n\nExclusion Criteria:\n\n* Contraindication to endovascular repair\n* Creatinine clearance \\\u003C 30ml\u002Fmin\n* History of severe allergy to iodinated contrast (anaphylaxis, bronchospasm)\n* Absence of recent previous thin-slice enhanced CT-scanner examination (stent planning based on MRI examination or non-enhanced CT examination).",{"count":19,"type":20},[23],"This project is aiming at the integration of a biomechanical computer program with a guidance code to simulate the endovascular repair (EVAR) procedure of abdominal aortic aneurysm (AAA). The computational time associated with finite element simulation generally renders its usage impractical for real-time application. Based on data collected during clinical interventions and a priori knowledge of AAA and endovascular device mechanical modeling, the investigators are proposing a deformable registration between preoperative CT-scans and per-operative fluoroscopy that will take into account prior simulations of participant specific EVAR procedures. To avoid the computational cost of a full finite element simulation, the investigators propose a simplified and real-time compliant repetitive mechanical behaviour based on participant specific parameters.\n\nThe results of this research will provide the Canadian industry with the first realistic deformable vascular geometry tool for live endovascular intervention guidance. The proposed biomechanical modeling can be translated to other vascular intervention procedure by adjusting the biomechanical parameters.",[26],[508,560,561,562,563,564],"Imaging, Three-Dimensional","Tomography Scanners, X-Ray Computed","Angiography, Digital Subtraction","Endovascular Procedures","Radiography, Interventional","2025-02-18",{"date":567,"type":31},"2025-02-19",{"date":569,"type":31},"2020-10-01",{"date":571,"type":20},"2026-05-29",{"name":573,"class":38},"Centre hospitalier de l'Université de Montréal (CHUM)",{"id":575,"slug":576,"hasResults":12,"nctId":577,"briefTitle":578,"officialTitle":579,"acronym":580,"eligibilityCriteria":581,"healthyVolunteers":12,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":582,"targetDuration":4,"studyType":21,"phases":584,"briefSummary":586,"conditions":587,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":592,"lastUpdatePostDateStruct":593,"startDateStruct":595,"completionDateStruct":597,"leadSponsor":599,"locationsCount":39},"100496437","phase-3-improved-recovery-by-iron-following-surgery-with-blood-loss-the-iris-trial-100496437","NCT05744219","Improved Recovery by Iron Following Surgery With Blood Loss, the IRIS-trial","Improved Recovery by Iron Following Surgery With Blood Loss, a Double-blind Multi-centre Randomized Controlled Phase III Drug Trial (the IRIS-trial)","IRIS","Inclusion Criteria:\n\n1. Provision of written informed consent\n2. Male and female patients\n3. Weight \\> 50 kg\n4. \\> 18 years of age\n5. Scheduled for complex aortic surgery, liver resection or pancreatic resection\n\nExclusion Criteria:\n\n1. Short expected survival (less than six months)\n2. Intra-venous iron therapy within one month prior to surgery\n3. Severe anaemia (B-Hb \\\u003C80 mg\u002FL) prior to surgery\n4. Contraindication to Ferric Carboxymaltose according to SmPC\n5. Iron overloading disorder, i.e. hemochromatosis\n6. Risk of small for size future liver remnant\n7. Pre-operative renal replacement therapy\n8. Enrolled in another drug or medical device study within 30 days prior to enrolment of the current study\n9. Another planned major surgical procedure before the five week follow up\n10. Unsuitable for inclusion according to the investigator\n11. Pregnancy",{"count":583,"type":20},338,[585],"PHASE3","The aim of the study is to investigate if iv iron formulation improve recovery after surgery with blood loss.\n\nPost-operative anaemia is a common debilitating condition after major surgery due to a combination of preoperative iron deficiency anaemia (IDA) and per-operative blood loss. Median blood loss following hepatopancreatobiliary (HPB) and complex aortic surgery typically range between 500-1000 ml. Bioavailability of iron may be a rate limiting factor in erythropoiesis in anaemia secondary to blood loss. For the IRIS trial, it is hypothesized that intravenously (iv) administered Ferric Carboxymaltose after a per-operative blood loss of 400-4000 ml, improves post-operative recovery and reduces the RBC transfusion.\n\nPatients scheduled for elective HPB surgery or complex aortic surgery will be screened for eligibility and recruited into the study.\n\nBy the end of the surgical procedure, if blood loss is estimated to 400-4000 ml, the patient is randomized 1:1 to iv 1000 mg Ferric Carboxymaltose or placebo.\n\nThe primary endpoint is a composite of death, number of RBC transfusions, post-operative severe anemia (Hb \\\u003C80 g\u002FL) and FACT-An Quality of life (QoL) five weeks after surgery, assessed by win ratio.\n\nThe trial will also examine effects on; a) levels of Hb; b) markers of erythropoiesis and iron bioavailability; c) post-operative complications; d) post-operative recovery; e) performance status; f) subgroups based on type of surgery and degree of anemia and iron deficiency; g) re-admissions; h) long term outcome based on patient medical records and i) how post-operative recovery differs between those with low (\\\u003C400 ml), high (400-4000 ml) and very high (\\>4000 ml) per-operative blood loss.\n\nRecruitment will continue until 338 patients are randomized or 304 have completed the five week follow up\n\nThe coordinating center of the trial is the Department of Surgery at Uppsala University Hospital. Participating sites are also Linköping University Hospital and Lund University Hospital, all in Sweden. Other sites may be added.",[588,589,590,591,26],"Surgery","Liver Metastases","Liver Cancer","Pancreas Cancer","2024-10-17",{"date":594,"type":31},"2024-10-21",{"date":596,"type":31},"2024-09-04",{"date":598,"type":20},"2028-03-30",{"name":600,"class":38},"Jon Unosson",{"id":602,"slug":603,"hasResults":12,"nctId":604,"briefTitle":605,"officialTitle":606,"acronym":4,"eligibilityCriteria":607,"healthyVolunteers":12,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":608,"targetDuration":4,"studyType":155,"phases":4,"briefSummary":609,"conditions":610,"keywords":4,"overallStatus":108,"whyStopped":4,"lastUpdateSubmitDate":611,"lastUpdatePostDateStruct":612,"startDateStruct":614,"completionDateStruct":616,"leadSponsor":618,"locationsCount":39},"100561587","ai-enhanced-imaging-analysis-to-predict-post-evar-100561587","NCT06592105","AI-enhanced Imaging Analysis to Predict Post-EVAR","AI-enhanced Imaging Analysis for the Prediction of Post-operative Outcomes Following EVAR","Inclusion Criteria:\n\n* Pre-operative CTA should be performed maximum 6 months before the intervention,\n* At least one post-operative CTA should be performed between 1 month and 12 months following the intervention,\n* CTA needs to be contrast-enhanced with at least injection at arterial and\u002For portal time,\n* CTA should have a spacing no more than 1 mm.\n\nExclusion Criteria:\n\n* age \\< 18 years, - patients with syndromic AAA,\n* patients who underwent open repair or complex EVAR (adjunctive sac embolization procedure, chimney\u002Fsnorkel or fenestrated-branched endografts),\n* ruptured AAA,\n* previous history of AAA repair,\n* patients for whom one pre-operative and at least one post-operative CTA (within 1-year) are not available.",{"count":231,"type":20},"Abdominal aortic aneurysm (AAA), defined as a focal dilatation of the aorta, is a life-threatening condition and has become a serious public health challenge worldwide, associated with high rates of mortality and hospitalization. Endovascular aortic repair (EVAR) requires long-term surveillance by a multidisciplinary team to detect and treat post-operative complications.This international, multicentre, retrospective, observational study aims to use Artificial Intelligence-enhanced imaging analysis for the prediction of post-operative outcomes following EVAR. The primary aim is to identify predictive factors and build prediction models of post-operative outcomes following eligible EVAR. The secondary objective is to investigate morphological aortic changes and remodelling following EVAR .\n\nScreening for eligible patients will be done by a vascular specialist at each participating centers. Only subjects fulfilling all the inclusion and none of the exclusion criteria will be accepted in the study.\n\nInclusion criteria from clinical characteristics may encompass the following: - patients who underwent elective EVAR for non-ruptured AAA for the first time, - patients who underwent non-complex EVAR procedure with commercially available endografts with CE mark, - patients with non-syndromic AAA or with non-infective AAA, - patients aged more than 18 years old. Inclusion criteria from CTA characteristics may encompass the following: - patients for whom one pre-operative and at least one post-operative CTA (within 1-year) can be collected in DICOM format. Detailed criteria for eligibility include the following: - Pre-operative CTA should be performed maximum 6 months before the intervention, - At least one post-operative CTA should be performed between 1 month and 12 months following the intervention, - CTA needs to be contrast-enhanced with at least injection at arterial and\u002For portal time, - CTA should have a spacing no more than 1 mm.Primary outcome will be EVAR-related complications including endoleaks, limb-occlusion and stent-graft migration. Secondary outcomes will include in-hospital length of stay post-intervention, re-interventions (with indication for re-intervention), and deaths (all-cause and aneurysm-related deaths). Outcomes will be investigated within 1 year and at the last follow-up of patients. Morphological changes following EVAR will be analyzed and compared based on pre-operative and post-operative CTA images. Images will be collected and analysed, using the PRAEVAorta 2 software (Nurea). Anatomic features measured include the measurement of aneurysm volume diameters and diameters (including AAA maximum diameter), measurement of intraluminal thrombus and calcifications, proximal and distal aneurysm neck lengths and diameters, suprarenal and infrarenal angulation, distal iliac landing zone length and diameter, and iliac tortuosity index. Based on the measurements, aneurysm sac will be classified into three categories: stable\u002F shrinkage\u002F expansion.The study will allow to identify predictive factors and develop predictive models of outcomes following eligible EVAR. By leveraging two approaches (traditional statistical analysis and AI-driven algorithms) and providing AI-enhanced detailed imaging analysis of the morphological characteristics of AAA, this study will allow a better understanding of pre-operative features predictive of the patients' outcomes.",[26],"2024-09-09",{"date":613,"type":31},"2024-09-19",{"date":615,"type":20},"2025-01-01",{"date":617,"type":20},"2028-01-01",{"name":619,"class":38},"Centre Hospitalier Universitaire de Nice",{"id":621,"slug":622,"hasResults":12,"nctId":623,"briefTitle":624,"officialTitle":625,"acronym":4,"eligibilityCriteria":626,"healthyVolunteers":12,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":627,"targetDuration":4,"studyType":155,"phases":4,"briefSummary":629,"conditions":630,"keywords":634,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":638,"lastUpdatePostDateStruct":639,"startDateStruct":641,"completionDateStruct":642,"leadSponsor":644,"locationsCount":39},"100555598","gastrointestinal-dysfunction-in-aortic-surgery-patients-100555598","NCT06514170","Gastrointestinal Dysfunction in Aortic Surgery Patients","Assessment of Gastrointestinal Dysfunction Through GIDS Scale and Intestinal Damage Biomarkers in Critically Ill Patients Undergoing Aortic Surgery and Its Association With Clinical Outcomes.","Inclusion Criteria:\n\n* 18 years of age or older.\n* Patients after surgical interventions (elective or urgency) on the aorta with cardiopulmonary bypass.\n* Invasive mechanical ventilation expected to be required more than 48 hours.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Patients under mechanical ventilation with pre-existing gastrointestinal issues.\n* Diagnosis of adult congenital heart disease.\n* Ongoing pregnancy or lactation period.\n* Simultaneous participation in another clinical study involving experimental therapy.\n* Presence of chronic intestinal disease.\n* Previous gastrointestinal conditions detected during nutritional screening.",{"count":628,"type":20},114,"The goal of this observational study is to determine the association of gastrointestinal dysfunction through the Gastrointestinal Dysfunction Scale (GIDS) tool and serum concentrations of citrulline and Intestinal fatty-acid binding protein (I-FABP) with primary \\[calories received, protein received, parenteral nutrition requirement and 28-day mortality in the intensive care unit (ICU)\\] and secondary (development of pneumonia, surgical and cardiovascular complications in the ICU, length of hospital and ICU stay, duration of mechanical ventilation) clinical outcomes in critically ill patients undergoing aortic surgery.",[26,631,55,632,633],"Gastrointestinal Dysfunction","Enteral Feeding Intolerance","Surgical Complication",[635,636,637],"Gastrointestinal dysfunction","Aortic diseases","Aorta surgery","2024-07-23",{"date":640,"type":31},"2024-07-24",{"date":638,"type":31},{"date":643,"type":20},"2026-06",{"name":645,"class":38},"Instituto Nacional de Cardiologia Ignacio Chavez"]