[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"abdominal-aortic-aneurysm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:abdominal-aortic-aneurysm":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,36,0,25,[9,43,70,98,121,148,169,209,237,261,290,319,341,365,395,420,440,459,480,499,526,561,584,604,630],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100534892","pain-control-after-aortic-endoaneurysmectomy-popeye-100534892",false,"NCT06244732","Pain Control After Aortic EndoaneurYsmEctomy (POPEYE)","Post-Operative Pain Control After Aortic EndoaneurYsmEctomy","POPEYE","Inclusion Criteria:\n\n* adult patients (age \\> 18 years)\n* patients who have given their consent to participate in the study\n* patients undergoing elective \"open\" surgical treatment of an abdominal aortic aneurysm with a midline xipho-pubic incision.\n\nExclusion Criteria:\n\n* Pregnant women\n* Patients being treated for chronic pain\n* Known allergy to drugs included in analgesia protocols\n* Contraindications to the use of one of the two methods provided:\n\n  * refusal by the patient\n  * infection at the puncture site\n  * coagulopathy:\n\n    1. PTT \\> 40 s and\u002For INR \\> 1.4\n    2. platelet count \\\u003C 50,000\u002FµL\n    3. taking antiplatelet or anticoagulant drugs that have not been discontinued in good time, according to international guidelines\n* Emergent intervention\n* Lack of consent to participate in the study","ALL","18 Years",{"count":21,"type":22},60,"ESTIMATED","INTERVENTIONAL",[25],"NA","Open abdominal aortic aneurysm repair (OR-AAA) is an operation associated with high morbidity, and has 30-day mortality rates of between 4 and 14%. Post-operative pain management represents a primary anesthetic focus.\n\nA better analgesia, in addition to being desirable for the patient, can potentially reduce complications associated with postoperative pain and ensure faster functional recovery.\n\nThe modern concept of multimodal analgesia involves the association of multiple drugs and\u002For analgesic techniques to maximize the quality of analgesia and reduce the side effects of the individual methods. In this context, the addition of epidural analgesia (EA) to the intravenous administration of \"traditional\" analgesic drugs has assumed the role of gold standard in many surgeries, including OR-AAA.\n\nOver time, EA has proven to be a better analgesic technique than the use of intravenous opioids alone, however there is much uncertainty regarding its ability to reduce complications, morbidity and mortality of patients.\n\nFor some time, efforts to research effective, less invasive and safe anesthetic alternatives, have been directed towards the development of multimodal analgesia protocols with the aim of reducing complications and ensuring faster recovery. New approaches to post-operative pain management are emerging, including rectus sheat block (RSB).\n\nCurrently there is no evidence regarding the effectiveness of RSB in pain control after OR-AAA.\n\nIn this context, the study aims to compare two different post-operative pain management protocols, with the aim of verifying whether the use of RSB can guarantee a non-inferior level of analgesia with reduction of complications compared to AE.",[28,29],"Postoperative Pain","Abdominal Aortic Aneurysm","RECRUITING","2026-07-01",{"date":33,"type":34},"2026-07-02","ACTUAL",{"date":36,"type":34},"2024-02-19",{"date":38,"type":22},"2027-03",{"name":40,"class":41},"IRCCS Policlinico S. Donato","OTHER",1,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":42},"100490359","endovascular-aortic-repair-with-sac-embolization-for-the-prevention-of-type-ii-endoleaks-the-evar-se-study-100490359","NCT05665101","EndoVascular Aortic Repair With Sac Embolization for the Prevention of Type II Endoleaks (the EVAR-SE Study)","EndoVascular Aortic Repair With Sac Embolization for the Prevention of Type II Endoleaks (the EVAR-SE Study)- A Randomized Controlled Multicentre Study in Germany","EVAR-SE","Inclusion Criteria:\n\n* Age ≥18 years\n* Infrarenal AAA ≥50 mm maximum diameter\n* Indication for EVAR within IFU of company\n* Presence of one or both high risk criteria on CT-A: ≥5 patent efferent vessels (inferior mesenteric and\u002For lumbar artery, and\u002For median sacral artery) or \\\u003C40% thrombus at largest AAA diameter\n\nExclusion Criteria:\n\n* Ruptured AAA\n* Fenestrated or branched EVAR\n* Concomitant iliac artery aneurysm\n* Non-ability to adhere to the FU protocol\n* Lack of consent\n* Pregnancy",{"count":52,"type":22},100,[25],"Beyond a certain threshold diameter, Abdominal aortic aneurysms (AAA) are treated by open surgical repair or, more often by endovascular aortic aneurysm repair (EVAR). The latter involves implantation of a stent-graft and thereby exclusion of the AAA from the blood circuit. Small vessels supplying parts of the bowel or the spine are regularly covered. In a quarter of patients, this may result in an inversion of blood flow in the mentioned vessels, leading to persistent blood flow within the AAA, referred to as type II endoleak (T2EL). Occurrence of T2EL is associated with complications like AAA growth or even rupture.\n\nSecondary interventions to treat T2EL often fail and may be highly invasive. Various risk factors for T2EL have been described. This enables prediction whether a patient is at high risk for T2EL after EVAR. Deployment of metal coils in the aneurysm sac as part of the EVAR procedure can reduce the risk for T2EL.The present study aims to assess the efficacy of sac embolization during EVAR to prevent T2EL.",[29,56],"Endoleak",[29,56,58,59,60],"Endovascular aortic aneurysm repair","Coiling","Endoleak Type II","2026-06-10",{"date":63,"type":34},"2026-06-12",{"date":65,"type":34},"2023-01-15",{"date":67,"type":22},"2028-04-30",{"name":69,"class":41},"Univ.-Prof. Dr. Dr. med. Daniela Branzan",{"id":71,"slug":72,"hasResults":12,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":97},"100558132","pilot-study-on-the-effectiveness-and-safety-of-optilene-silver-mesh-elastic-in-prevention-of-surgical-site-infection-ssi-and-incisional-hernia-ih-100558132","NCT06547138","Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)","Prospective Descriptive Multicentre Pilot Study On The Effectiveness and Safety Of Optilene® Silver Mesh Elastic In Prevention Of Surgical Site Infection (SSI) And Incisional Hernia (IH)","SSIHLVER","Inclusion Criteria:\n\n* Adult patients (18 years or older)\n* Surgical procedure requiring urgent, primary median laparotomy, which are classified as \"Class III\u002FContaminated\" or \"Class IV\u002FDirty-Infected\" regarding the CDC classification.\n\nThese include but are not limited to:\n\n* Vascular surgery\n* Colon and rectum\n* Hepatobiliary\n* Gastrointestinal\n* Gynecology\n* Urology\n* Abdominal Aortic Aneurysm (AAA) repair\n* Right hemicolectomy\n* Left hemicolectomy\n* Sigmoidectomy\n* Anterior resection\n* Abdominoperineal amputation\n* Exploratory laparotomy\n* Cholecystectomy\n* Cholecystectomy and choledocotomy\n\n  * Written informed consent\n\nExclusion Criteria:\n\n* Pregnancy\n* Breast feeding\n* Patients \\\u003C 18 years old or patients who are still in the growth phase\n* Contaminated and infected areas\n* Hypersensitivity to silver\n* Direct contact with the viscera\n* Previous allergic reactions to components of the device\n* Patient with previous laparotomy\n* Transverse laparotomy\n* Patients with previous hernia repair\n* Simultaneous participation in another investigational clinical trial (drug or medical studies)\n* Patients with active oncologic treatment (chemo and radiotherapy)\n* Underlying autoimmune disease\n* Recent cardiovascular complication\n* Gynecology surgery\n* Urology surgery\n* Vascular surgery",{"count":79,"type":22},110,"OBSERVATIONAL","The aim of the study is to describe the effectiveness of Optilene® Silver Mesh Elastic on prevention of surgical site infection (SSI) at 6 months follow-up in patients undergoing urgent laparotomy by collecting clinical data on the SSI rates, IH rates and overall clinical performance of Optilene® Silver Mesh Elastic used for the prevention of incisional hernia as prophylactic mesh in patients that require urgent median laparotomy in clinical routine.",[29,83],"Morbid Obesity",[85],"urgent, primary median laparotomy","NOT_YET_RECRUITING","2026-06-01",{"date":89,"type":34},"2026-06-02",{"date":91,"type":22},"2026-09",{"date":93,"type":22},"2028-09",{"name":95,"class":96},"Aesculap AG","INDUSTRY",5,{"id":99,"slug":100,"hasResults":12,"nctId":101,"briefTitle":102,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":104,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":107,"conditions":108,"keywords":109,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":42},"100635085","molecular-imaging-of-the-underlying-mechanism-of-vessel-wall-inflammation-using-positron-emission-tomography-petct-100635085","NCT07548099","Molecular Imaging of the Underlying Mechanism of Vessel Wall Inflammation Using Positron Emission Tomography (PET\u002FCT)","Inclusion Criteria:\n\n1. Participants will be at least 18 years of age\n2. Have an established diagnosis of abdominal aortic aneurysm based on standard clinical criteria or are an age matched control with absence of known AAA.\n3. Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.\n\nExclusion Criteria:\n\n1. Females who are pregnant or breast feeding at the time of the PET\u002FCT scan will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential before the injection of radiotracer.\n2. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician\n3. Patients with chronic renal disease whose GFR is less than 40 mL\u002Fmin\u002F1.73m² at the time of enrollment.\n4. Documented allergy to iodinated contrast\n5. Any current medical condition, illness, or disorder as assessed by medical record review and\u002For self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study\n6. Less than 6 months life expectancy as deemed by the treating physician at the time of initial enrollment.",true,{"count":106,"type":22},30,"This research study is being conducted to test how an imaging drug called 64Cu-DOTA-ECL1i can be used to image an abdominal aortic aneurysm. 64Cu-DOTA-ECL1i is a drug used with an imaging test called a PET\u002FCT (Positron Emission Tomography\u002FComputed Tomography).\n\nThe aim is to collect data using a new imaging drug called 64Cu-DOTA-ECL1i that may be able to create images of inflammation in the aorta, which is thought to be important in how aneurysms grow and develop and to understand how consistent these scans are across time and what might affect the inflammation.",[29],[110,111],"aortic aneurysm","aortic inflammation","2026-05-21",{"date":114,"type":34},"2026-05-22",{"date":116,"type":34},"2026-04-30",{"date":118,"type":22},"2029-04-30",{"name":120,"class":41},"University of Pennsylvania",{"id":122,"slug":123,"hasResults":12,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":127,"eligibilityCriteria":128,"healthyVolunteers":12,"sex":18,"minAge":129,"maxAge":130,"enrollmentInfo":131,"targetDuration":4,"studyType":23,"phases":133,"briefSummary":136,"conditions":137,"keywords":138,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":147},"100516238","phase-2-nectero-east-system-clinical-study-100516238","NCT06001918","Nectero EAST System Clinical Study","Randomized Controlled Clinical Trial (RCT) of the Nectero EAST System for Small to Mid-Sized Abdominal Aortic Aneurysms (AAA) StaBiLization: Evaluation of Efficacy.","stAAAble","Inclusion Criteria:\n\n1. Males and females ≥21 to ≤85 years of age. Females must be of non-childbearing potential (menopause or sterilization).\n2. Subject understands the purpose of the trial, agrees to voluntarily participate in the trial, signs the informed consent and is willing to complete the follow-up according to the requirements of the protocol.\n3. Infrarenal atherosclerotic fusiform abdominal aortic aneurysm from 3.5 cm to 5.0 cm (male) and 3.5 cm to 4.5 cm (female).\n4. Infrarenal aortic neck ≥ 15 mm in length and ≤ 29 mm in diameter.\n5. Overall AAA treatment length (distal renal to distal inferior margin of the aneurysm) not to exceed 130 mm.\n6. Iliac and femoral artery access, vessel size and morphology allow endovascular access of 14F (or larger) introducer sheaths and catheters.\n7. Subject meets American Society of Anesthesiology (ASA) grade 1 through 3 criteria, inclusive.\n8. Subject has \\> three-year life expectancy.\n9. Subject is able and willing to comply with all required follow-up clinic visits including CT scans (pre-randomization, 6, 12, 18, 24 months and annually up to 5 years) and blood draws.\n\nExclusion Criteria:\n\n1. Subject has an acutely ruptured, leaking, dissecting or emergent aneurysm.\n2. Subject has a symptomatic infrarenal abdominal aortic aneurysm.\n3. Subject has a mycotic or infected aneurysm.\n4. Subject has current vascular injury due to trauma.\n5. Subject's aneurysm is thoracic, suprarenal or juxtarenal.\n6. Previous surgical or endovascular aneurysm repair for abdominal aortic aneurysm.\n7. Subject has anatomy of diffuse, ulcerated, or extensive (shaggy) thrombus in the neck of the AAA, that in the opinion of the vascular surgeon\u002Finvestigator, could result in embolization of the thrombus.\n8. Subject has anatomy of calcification, and\u002For plaque within the ilio-femoral arteries or severe infrarenal neck angulation that may compromise or does not allow delivery of the Introducer Sheath or the delivery catheter of the Nectero EAST System.\n9. Subject has had a myocardial infarction within six (6) months prior to enrollment or elevated CK enzymes or troponin indicative of an evolving MI prior to procedure.\n10. Subject has current angina, unstable angina, or other active cardiac condition such as congestive heart failure III and IV, atrial arrhythmia, ventricular arrhythmia, or valvular disease, requiring intervention.\n11. Subject has undergone other major surgery within the 30 days prior to enrollment.\n12. Subjects with any transient ischemic attack (TIA) or ischemic stroke within 3 months.\n13. Known allergy to contrast material that cannot be adequately premedicated, delivery system materials (i.e., nylon, polyurethane) and\u002For pentagalloylglucose (PGG).\n14. Subject is morbidly obese or has other clinical conditions that severely inhibit X-ray visualization of the aorta.\n15. Subject has connective tissue\u002Fcollagen disorder (e.g., Marfan syndrome, vascular Ehlers-Danlos Syndrome, Loeys-Dietz Syndrome, Eaton Syndrome, Bessel-Hagen disease, etc.).\n16. Known contraindication to undergoing angiography or receiving systemic anticoagulation during the procedure.\n17. Subject has active systemic infection.\n18. Subject is participating in another research trial that could interfere with the results of the trial (e.g., drug trial).\n19. Subject has other medical, social, or psychological problems that, in the opinion of the investigator, preclude them from participation in the trial and to undergo the procedures and evaluations pre- and post-treatment.\n20. Subject has dialysis dependent renal failure or baseline serum creatinine level \\>2.5mg\u002FdL or eGFR \\\u003C 45 mL\u002Fmin\u002F1.73m2.\n21. Subjects with aminotransferase (ALT and\u002For AST) which is ≥1.5x upper limit of normal (ULN) or TB that is our of normal range for the evaluating laboratory.\n22. Subjects that may not tolerate the lowering of their systolic blood pressure to approximately 100mmHg, should not be considered for this study or treated using the Nectero EAST System.\n23. Subjects that may not be able to tolerate transient occlusion of the aorta should not be considered for this study.\n24. Subjects with saccular AAA.\n25. Subjects with rapidly expanding AAA (previous diameter increases of ≥0.5 cm in 6-months or ≥1 cm in 1 year) as these should be evaluated for immediate repair.\n26. Subjects who are not suitable for the Nectero EAST System treatment, as determined by the investigator.\n27. Subjects with INR out of normal range for the evaluating laboratory for a subject not on anti-coagulant therapy; or INR \\>3 for a subject on anti-coagulant therapy.\n28. Subjects with active\u002Facute or a history of unstable chronic liver disease or current liver disease including but not limited to liver transplant, known genetic disorders such as Gilbert syndrome or other liver diseases.\n29. Subjects with cirrhosis (e.g., known history or new clinical diagnosis by elastography with a fibrosis score of F3 or F4 and\u002For steatosis grade of S3).\n30. Subjects with uncontrolled alcohol use disorder or current alcohol use putting them at risk of liver disease: including consumption of above one standard drink per day for women and two standard drinks per day for men.\n31. Subjects with known right-sided heart failure or pathologically dilated inferior vena cava or hepatic veins indicative of congestive hepatopathy.","21 Years","85 Years",{"count":132,"type":22},400,[134,135],"PHASE2","PHASE3","The purpose of this randomized clinical trial is to treat patients with small to mid-sized abdominal aortic aneurysms (AAA), maximum diameter of 3.5 cm to 5.0 cm, using a locally delivered, single-dose endovascular treatment. The main question the study aims to answer is to demonstrate efficacy of the product for stabilization of these small to mid-sized AAA.The study will compare the treatment group to the typical standard of care for these patients, surveillance. All subjects will be followed at designated intervals at 30\u002F60 days, 6, 12, 18 and 24 months with continued follow-up annually for up to 5 years.",[29],[29],{"date":140,"type":34},"2026-05-26",{"date":142,"type":34},"2023-10-25",{"date":144,"type":22},"2032-12-31",{"name":146,"class":96},"Nectero Medical, Inc.",39,{"id":149,"slug":150,"hasResults":12,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":4,"eligibilityCriteria":154,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":155,"targetDuration":4,"studyType":23,"phases":157,"briefSummary":159,"conditions":160,"keywords":4,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":42},"100522325","early-phase-1-mechanistic-clinical-trial-of-pcsk9-inhibition-for-aaa-100522325","NCT06081153","Mechanistic Clinical Trial of PCSK9 Inhibition for AAA","A Randomized, Placebo-Controlled Mechanistic Clinical Trial of PCSK9 Inhibition With Evolocumab in Patients Undergoing Open Abdominal Aortic Aneurysm Repair","Inclusion Criteria:\n\n1. Abdominal aortic aneurysm (AAA) requiring open surgical repair\n2. Age \\> 18\n3. Provision of signed and dated informed consent form\n4. Stated willingness to comply with all study procedures and availability for the duration of the study\n\nExclusion Criteria:\n\n1. Prior use of a PCSK9 inhibitor (evolocumab, alirocumab, inclisiran) within 6 months of the baseline visit\n2. LDL-C \\\u003C 40 mg\u002FdL (within 3 months of baseline visit)\n3. Known allergy to PCSK9 inhibitor\n4. Aortic dissection\n5. Vascular connective tissue disorders\n6. Type I-III or V Thoraco-abdominal Aortic Aneurysm\n7. Vasculitis or inflammatory aneurysm\n8. Pregnant or lactating women\n9. Poorly controlled diabetes (A1C \\> 10%)\n10. Chronic kidney disease Stage 4\u002F5 or End Stage Renal Disease (ESRD) on hemodialysis (HD)\n11. Liver Disease (alanine transaminase \\[ALT\\] or aspartate aminotransferase \\[ALT\\] \\> 3.0 x upper limits of normal) (within 3 months of baseline visit)\n12. Known latex or naturally rubber allergy\n13. Treatment with another investigational product within 30 days or 5 half-lives of the investigation drug before consent (whichever is longer) that would have an impact on endpoints associated with this trial.\n14. Any other condition that the Investigator feels prohibits participants' ability to comply with study or follow up.",{"count":156,"type":22},44,[158],"EARLY_PHASE1","The goal of this mechanistic clinical trial is to assess whether lowering the low-density lipoprotein cholesterol (LDL-C) levels in the blood with the injections of the medication evolocumab will have any effect on the tissue or cells of patients with abdominal aortic aneurysm (AAA). Researchers will compare participants receiving evolocumab injections to participants receiving placebo injections to see how the tissue and cells of the aorta are affected by changes in LDL-C levels.",[29],"2026-04-16",{"date":163,"type":34},"2026-04-20",{"date":165,"type":22},"2026-12-01",{"date":167,"type":22},"2029-02-28",{"name":120,"class":41},{"id":170,"slug":171,"hasResults":12,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":4,"eligibilityCriteria":175,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":176,"targetDuration":4,"studyType":23,"phases":177,"briefSummary":178,"conditions":179,"keywords":184,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":42},"100590616","evaluation-of-clinical-efficacy-and-safety-of-aortal-stent-graft-created-using-3d-printing-technology-100590616","NCT06969729","Evaluation of Clinical Efficacy and Safety of Aortal Stent-Graft Created Using 3D Printing Technology","Evaluation of Clinical Efficacy and Safety of Aortal Stent-graft Modelled Printing 3D Model Printing Technology - Multicenter, Randomized Clinical Trial","Inclusion Criteria:\n\nFemale and male subjects age ≥ 18 2. Subject need to meet one of the following criteria:\n\n* Subjects with juxtarenal or suprarenal abdominal aortic aneurysm, type IV thoracoabdominal aneurysm of diameter \\>5.5cm (male) and 5.2cm (female)\n* Subjects with juxtarenal or suprarenal abdominal aortic aneurysm, type IV thoraco-abdominal aneurysm with aneurysm growth rate ≥ 0.5cm during 6 months\n* Type IA endoleak of post-implantation of abdominal stent- graft 3. Iliac arteries morphology with aortic stent graft implantation to be restored 4. Aortic segment which is proximal to aneurysm\n* Length ≥20mm\n* Diameter 20mm-36mm\n* Aortic suprarenal angle ≤75 degrees 5. Survival \\> 2 years\n\nExclusion Criteria:\n\n1. Female and male subjects age \\\u003C18\n2. Pregnancy and breast feeding\n3. Allergy and hypersensitivity to matherials of which the stent- graft is composed\n4. Hypersensitivity and contraindication to anti coagulation or contrast application to angio - CT which cannot be eliminated medically\n5. Coagulopathy which cannot medically treated\n6. Active infection which might cause stent - graft infection\n7. Creatinine level \\> 3.0mg\u002FdL\n8. Marphan syndrome, Ehlers - Denlos syndrome\n9. Unstable angina pectoris\n10. Raptured aortic aneurysm caused by cardiac insufficiency\n11. Unwillingness to comply with protocol procedures\n12. Iliac arteries morphology adequate for stent-graft implantation\n13. The diameter of the aortic flow lumen in reno-visceral aorta greater than 34mm\n14. Aortic section which is proximal to celiac artery with significant number of thrombi, calcification or changed by aneurysm\n15. Aorta with significant number of irregular thrombi which may lead to embolism (\"shaggy aorta\")\n16. Diameter of proximal kidney arteries which is exercisable to stenting \\\u003C4.5mm\n17. Devision of kidney artery which is exercisable to stenting in the distance of \\\u003C1cm of celiac artery, each of them is is in \\\u003C4.5mm in diameter\n18. Atypical anatomy of celiac artery in the form of separate exit of splenic and hepatic aortic artery",{"count":52,"type":22},[25],"the comparison of physician-modified stent-graft created in 3D models versus custom-made devices in the treatment of complex abdominal aortic aneurysm",[29,180,181,182,183],"Juxtarenal Abdominal Aortic Aneurysm","Pararenal Abdominal Aortic Aneurysm","Thoracoabdominal Aortic Aneurysm","Type IA Endoleak",[185,186,187,188,189,190,191,192,193,194,195,196,197,198,199,200],"AAA","physician-modified stent-graft","custom-made device","complex abdominal aortic aneurysm","juxtarenal abdominal aortic aneurysm","pararenal abdominal aortic aneurysm","thoracoabdominal aortic aneurysm","endovascular aneurysm repair","3D printing","3D model","PMEG","type IA endoleak","aortic stent-graft","PMSG","patient-specific 3D model","complex aortic pathology","2026-04-13",{"date":161,"type":34},{"date":204,"type":34},"2022-11-01",{"date":206,"type":22},"2027-04-30",{"name":208,"class":41},"Samodzielny Publiczny Szpital Kliniczny nr 2 PUM",{"id":210,"slug":211,"hasResults":12,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":215,"eligibilityCriteria":216,"healthyVolunteers":12,"sex":18,"minAge":217,"maxAge":4,"enrollmentInfo":218,"targetDuration":4,"studyType":23,"phases":220,"briefSummary":221,"conditions":222,"keywords":225,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":236},"100468328","endurant-stent-graft-system-vs-excluder-endoprothesis-advance-trial-100468328","NCT05378347","Endurant Stent Graft System vs Excluder Endoprothesis: ADVANCE Trial","Endurant Stent Graft System vs Excluder Endoprothesis: A Global, Prospective, Randomized Clinical Trial in Sac Regression","ADVANCE","Inclusion Criteria:\n\n* Subject and the treating physician agree that the subject will return for all required follow up visits\n* Subject or legal representative or consultee, as applicable, has consented for trial participation and signed the Informed Consent approved by the sponsor and by the Ethics Committee\u002FInstitutional Review Board\n* Subject has an aneurysm diameter of ≥ 5 cm (if woman) ≥ 5.5 cm (if man) or as stated otherwise in regional addenda.\n* Subject's AAA anatomy is appropriate for both Medtronic Endurant II\u002FIIs Stent Graft System and Gore Excluder\u002FExcluder Conformable AAA Endoprosthesis as per assessment of both treating physician and Core Lab in accordance with the overlapping commercially available IFUs per applicable region.\n\nExclusion Criteria:\n\n* Subject is participating in an investigational drug or device study which may bias or interfere with the endpoints and follow-up of this trial\n* Subject has an estimated life expectancy of ≤ 3 years as judged by the investigator\n* Subject has an aneurysm that is:\n\n  1. Suprarenal\u002Fpararenal\u002Fjuxtarenal\n  2. Isolated ilio-femoral\n  3. Mycotic\n  4. Inflammatory\n  5. Pseudoaneurysm\n  6. Concomitant or prior dissection involving the abdominal aorta or iliac arteries\n  7. Ruptured\n  8. Symptomatic AAA\n* Subject has significant thrombus and \u002F or calcium at the arterial implantation sites, specifically the proximal aortic neck and distal iliac artery interface. Significant thrombus may be quantified as thrombus ≥ 2 mm in thickness and \u002F or ≥ 25% of the vessel circumference in the intended seal zone of the aortic neck.\n* Subject requires emergent aneurysm treatment, for example, trauma or rupture\n* Subject with connective tissue disease that may have caused the aneurysm e.g. Marfan syndrome, Ehlers-Danlos, Loeys-Dietz syndrome\n* Subject has previously undergone surgical or endovascular treatment in the abdominal aorta or the iliac arteries for aneurysm or occlusive disease\n* Planned use of aorto-uni-iliac (AUI) main body device\n* Any planned additional device (apart from the main body, limb stent graft and extensions per assigned treatment per randomization) during index or staged procedure, e.g., endostaple or anchor, Iliac branch endoprosthesis, embolization, etc.\n* Planned coverage of the internal iliac artery\u002Farteries\n* Subject has an estimated glomerular filtration rate (eGFR) \\\u003C 45 ml\u002Fmin\u002F1.73m2 or subject is on dialysis\n* Subject has a systemic infection who may be at increased risk of endovascular graft infection, per investigator's discretion\n* Subject has a psychiatric or other condition that may interfere with the trial, per investigator's discretion\n* Subject is of childbearing potential in whom pregnancy cannot be excluded\n* Subject has a known hypersensitivity or contraindication to anticoagulants, anti-platelets, or contrast media, which is not amenable to pre-treatment\n* Subject belongs to a vulnerable population per investigator's judgment\n* Subject has an active COVID-19 infection or relevant history of COVID- 19","20 Years",{"count":219,"type":22},600,[25],"The purpose of this trial is to generate clinical evidence related to key performance outcomes of Endurant II\u002FIIs Stent Graft Systems verses Gore Excluder \u002F Excluder Conformable AAA Endoprosthesis in subjects with Abdominal Aortic Aneurysms. Subjects are randomized and imaging collected at all follow-up time points to assess the primary endpoint.",[29,223,224],"Abdominal Aortic Aneurysm >= 5.5 Centimeters in Male (Disorder)","Abdominal Aortic Aneurysm >= 5.0 Centimeters in Female (Disorder)",[226],"EVAR, AAA","2026-04-02",{"date":229,"type":34},"2026-04-08",{"date":231,"type":34},"2023-01-05",{"date":233,"type":22},"2031-05",{"name":235,"class":96},"Medtronic Cardiovascular",68,{"id":238,"slug":239,"hasResults":12,"nctId":240,"briefTitle":241,"officialTitle":242,"acronym":4,"eligibilityCriteria":243,"healthyVolunteers":12,"sex":18,"minAge":129,"maxAge":4,"enrollmentInfo":244,"targetDuration":4,"studyType":23,"phases":246,"briefSummary":247,"conditions":248,"keywords":250,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":254,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":42},"100419818","safety-and-efficacy-of-endovascular-repair-of-complex-aortic-pathology-with-physician-modified-endovascular-grafts-pmegs-100419818","NCT04746677","Safety and Efficacy of Endovascular Repair of Complex Aortic Pathology With Physician-modified Endovascular Grafts (PMEGs)","Single-Center Investigational Device Exemption Trial: Safety and Efficacy of Endovascular Repair of Complex Aortic Pathology With Physician-modified Endovascular Grafts (PMEGs)","INCLUSION CRITERIA:\n\nGeneral inclusion criteria (applicable to all 3 study arms):\n\n* Aortic pathology that fits one of the study arms (see below for detailed description)\n* Aortic pathology that cannot be treated within the Instructions for Use of an FDA- approved, commercially-available device\n* Aortic aneurysm that can be treated within the Instructions for Use of an FDA-approved, commercially-available custom-manufactured device but deemed unsafe to wait the required time for device manufacturing\n* Subject is at high-risk of morbidity and mortality with open surgical repair based on cardiopulmonary function, extent of comorbid disease, and anatomic complexity\n* Iliac and\u002For femoral access vessel morphology that is compatible with vascular access techniques, devices, or accessories, with or without use of a surgical or endovascular conduit\n* Non-aneurysmal aortic segment proximal to the aortic pathology with a:\n\n  * Minimum neck length of 20 mm\n  * Diameter between 20 - 42 mm\n* Non-aneurysmal aortic or iliac segment distal to the aortic pathology with:\n\n  * Aortic distal fixation site greater than 20 mm in length and diameter between 20-42 mm\n  * Iliac artery distal fixation site greater than 10 mm in length and diameter range 8- 25 mm\n* Age ≥21 years old\n* Life expectancy: ≥2 years\n\nArm1:\n\n* Complex abdominal aortic aneurysm, specifically juxtarenal or suprarenal abdominal aortic aneurysm or type IV thoracoabdominal aortic aneurysm, with maximum diameter of ≥5.5 cm for men or ≥5.0 cm for women, growth ≥0.5 cm in 6 months, or concomitant iliac aneurysm ≥3 cm\n* Prior endovascular aortic aneurysm repair with loss of proximal seal requiring incorporation of the renal arteries, SMA, and\u002For CA for repair, without aneurysmal disease extending above the diaphragmatic hiatus\n* Prior open abdominal aortic aneurysm repair with aneurysmal disease proximal to the repair requiring incorporation of the renal arteries, SMA, and\u002For CA for repair, without aneurysmal disease above the diaphragmatic hiatus\n* Saccular complex abdominal aortic aneurysm deemed at significant risk for rupture\n* Symptomatic complex aortic aneurysm\n* Penetrating aortic ulcer with depth ≥1 cm or width ≥2 cm, for which endovascular repair requires incorporation of the renal arteries, SMA, and\u002For CA, without involvement of the aorta above the diaphragmatic hiatus\n* Aortic pseudoaneurysm for which endovascular repair requires incorporation of the renal arteries, SMA, and\u002For CA, without involvement of the aorta above the diaphragmatic hiatus\n\nArm2:\n\n* Type I, II, or III thoracoabdominal aortic aneurysm with maximum diameter of ≥5.5 cm, or growth ≥0.5 cm in 6 months\n* Prior endovascular aortic aneurysm repair with loss of proximal seal requiring incorporation of the renal arteries, SMA, and\u002For CA for repair with aneurysmal disease extending above the diaphragmatic hiatus\n* Prior thoracic endovascular aneurysm repair with loss of distal seal requiring incorporation of the renal arteries, SMA, and\u002For CA for repair\n* Prior open abdominal aortic aneurysm repair with aneurysmal disease proximal to the repair requiring incorporation of the renal arteries, SMA, and\u002For CA for repair, with aneurysmal disease above the diaphragmatic hiatus\n* Saccular type I, II, or III thoracoabdominal aortic aneurysm deemed at significant risk for rupture\n* Symptomatic type I, II, or III thoracoabdominal aortic aneurysm\n* Penetrating aortic ulcer with depth ≥1 cm or width ≥2 cm, for which endovascular repair requires incorporation of the renal arteries, SMA, and\u002For CA, with involvement of the aorta above the diaphragmatic hiatus\n* Aortic pseudoaneurysm for which endovascular repair requires incorporation of the renal arteries, SMA, and\u002For CA, with involvement of the aorta above the diaphragmatic hiatus\n\nArm 3:\n\n* Acute or chronic type B aortic dissection with indication for repair including, but not limited to renal, mesenteric, or lower extremity malperfusion, progression of dissection, or persistence of symptoms despite optimal medical therapy\n* Prior repair of type A dissection and development of acute or chronic type B dissection component with indication for repair (listed above)\n* Aortic intramural hematoma (IMH) with indication for repair including, but not limited to renal, mesenteric, or lower extremity malperfusion, progression of dissection, or more typically, persistence of symptoms despite optimal medical therapy\n\nArm 4\n\n* Patient does not meet the inclusion\u002Fexclusion criteria of Arms 1 - 3\n* Patient has prohibitive operative risk for open repair and no other viable endovascular treatment option\n* Estimated perioperative risk is lower than the estimated 1-year mortality without surgery\n\nEXCLUSION CRITERIA:\n\nGeneral Exclusion Criteria\n\n* Subject is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site\n* Subject is unwilling to comply with the follow-up schedule\n* Inability or refusal to give informed consent by subject or legal representative\n* Subject is pregnant or breastfeeding\n* Subject has a ruptured aneurysm\n\nArm 5 • Patient meets criteria for Arms 1-4\n\n\\- Patient is undergoing repair using the TREO bifurcated stent graft\n\nIndications for using TREO bifurcated stent graft:\n\n* Patient has undergone a prior endovascular aortic repair and meets criteria for repair; OR\n* -Patient has measured length from the lowest renal artery to the aortic bifurcation (either de novo or from a prior endograft) \\\u003C 115 mm; OR\n\n  * In patients with notable vessel tortuosity, where centerline measurement may not accurately reflect the distance covered needed in situ; OR\n  * Additional clinical or anatomic scenarios where forthcoming experience may demonstrate the TREO endograft to be superior to the currently-used Alpha\u002FAlpha 2 endograft.\n\nMedical Exclusion Criteria\n\n* Known sensitivities or allergies to the materials of construction of the devices\n* Known hypersensitivity or contraindication to anticoagulation or contrast media that cannot be adequately medically managed\n* Uncorrectable coagulopathy\n* Body habitus that would inhibit x-ray visualization of the aorta or exceeds the safe capacity of the equipment\n* Systemic or local infection that may increase the risk of endovascular graft infection\n* Diagnosis of connective tissue disorders (e.g., Marfan Syndrome, Ehler's Danlos Syndrome)\n\nAnatomic Exclusion Criteria\n\n* Inability to perform open or endovascular iliac conduit in patients with inadequate femoral\u002Filiac access\n* Excessive thrombus or calcification within the neck of the aneurysm\n* Visceral vessel anatomy not compatible with placement of a physician-modified endovascular graft due to occlusive disease or small size",{"count":245,"type":22},220,[25],"The primary objective of this study is to examine the safety and effectiveness of physician-modified endovascular grafts (PMEGs) for endovascular repair of complex aortic pathology in high-risk patients. The study is divided into three study arms based on the subject's aortic pathology: (1) Complex abdominal aortic aneurysm (AAA); (2) Thoracoabdominal aortic aneurysm; and (3) Aortic dissection.",[29,182,249],"Aortic Dissection",[251,252,253],"Fenestrated endovascular aortic repair","Branched endovascular aortic repair","Complex aortic aneurysm repair",{"date":229,"type":34},{"date":256,"type":34},"2021-03-15",{"date":258,"type":22},"2031-03-31",{"name":260,"class":41},"Beth Israel Deaconess Medical Center",{"id":262,"slug":263,"hasResults":12,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":267,"eligibilityCriteria":268,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":269,"targetDuration":271,"studyType":80,"phases":4,"briefSummary":272,"conditions":273,"keywords":274,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":289},"100629555","poland-italy-aortic-research-bridge-real-world-registry-100629555","NCT07476196","Poland-Italy Aortic Research Bridge Real World Registry","A Pragmatic, Observational, Multicenter Registry on the Implantation of the Tri Modular PERCUTEK Tycheseal™ Endograft System for the Treatment of Abdominal Aortic Aneurysm (AAA)","POWER","Anatomical Inclusion Criteria (as per IFU):\n\n* Morphologically suitable aneurysm\n* Neck length ≥ 10 mm\n* Neck diameter suitable for 20-36 mm body (considering 10-20% of oversizing)\n* Neck angle: infrarenal ≤ 75°\n* Distal seal zone ≥ 10 mm\n* Iliac arteries 8-20 mm diameter\n\nPatient Inclusion Criteria:\n\n* Age \\>18 years\n* Signed informed consent\n* Pregnancy test for premenopausal women\n\nExclusion Criteria:\n\n* Anatomical unsuitability\n* Subject has a life expectancy \\\u003C 1 year\n* Circumferential thrombus in neck\n* Ruptured aneurysm\n* Renal arteries from aneurysm sac\n* Dominant IMA with obstructed visceral vessels\n* Internal iliac artery aneurysms (unless pre-treated)\n* Subject has a known contraindication dual antiplatelets therapy or contrast media,\n* Selected patients with chronic kidney failure (CKF) can undergo EVAR using standard contrast or CO2 as contrast agent.\n* Previous aortoiliac surgery or EVAR\n* Recent stroke\u002FMI (\\\u003C 3 months)\n* Allergy to device materials",{"count":270,"type":22},200,"24 Months","Objective To pragmatically collect and analyze patient-level clinical, procedural, and outcome data from participating centers in Italy and Poland on the use of the PERCUTEK Tycheseal™ stent-graft system for the endovascular repair of abdominal aortic aneurysms. The study aims to generate high-quality, real-world evidence on the technical success, safety, and mid-term outcomes of the device.\n\nStudy Design This is a pragmatic, observational, multicenter physician-initiated registry that will collect patient-level data for all eligible patients undergoing PERCUTEK Tycheseal™ device implantation. Each site will enter data into a standardized paper case report form (CRF), including demographic, anatomical, procedural, and follow-up variables. Sites will be expected to comply with data entry timelines and quality control checks. The total projected enrollment is 120-200 patients across all sites over an expected 18 month inclusion period.\n\nThe target enrollment is 120-200 patients across all participating sites.",[29],[275,276,277,278,279],"Abdominal aortic aneurysm","Endovascular Aneurysm Repair","PERCUTEK Tycheseal™","vascular disease","stent graft","2026-03-18",{"date":282,"type":34},"2026-03-20",{"date":284,"type":34},"2026-03-01",{"date":286,"type":22},"2030-03-31",{"name":288,"class":41},"American Heart of Poland",26,{"id":291,"slug":292,"hasResults":12,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":296,"eligibilityCriteria":297,"healthyVolunteers":12,"sex":18,"minAge":298,"maxAge":4,"enrollmentInfo":299,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":300,"conditions":301,"keywords":304,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":310,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":316,"locationsCount":318},"100629483","svf-treo-study-influence-of-cardiac-and-respiratory-pulsatility-deformation-100629483","NCT07475260","SVF-Treo Study: Influence of Cardiac and Respiratory Pulsatility Deformation","Investigating the Influence of Cardiac and Respiratory Pulsatility Deformation on the Abdominal Aorta Before and After the Implantation of the Fenestrated TREO.","SVF-Treo","Inclusion Criteria:\n\n* Asymptomatic AAA,\n* Age \\> 65\n* Indication for AAA treatment according to standard practice\n* Anatomic suitability for the fenestrated Treo stent graft\n* At least one stentable main renal artery and one other stentable renal or mesenteric artery\n* Being able to hold their breath for 10 seconds.\n\nExclusion Criteria:\n\n* No informed consent obtained\n* eGFR \\\u003C 30 ml\u002Fmin\n* Allergy for intra venous contrast fluid.","65 Years",{"count":7,"type":22},"This is a national multicenter study with 25 patients with a complex AAA undergoing endovascular repair with the Fenestrated TREO™ stent graft. ECG and respiratory-gated CT scans will be performed pre-operatively, at discharge, after 6 months, and after 12 months follow up. If stent movement is still present in after 12 months, then another scan will be taken at 24 months. To include respiratory gated with the ECG-gated, patients will undergo ECG-gated CT scan during an inspiration breath-hold as well as an expiration breath-hold. This double gated CT scans will allow us to analyse the movement of the stent graft caused by the cardiac cycle and respiratory cycle.\n\nThe duration of this study is 2.5 years.",[29,302,303],"Endovascular Abdominal Aortic Aneurysm Repair","Fenestrated Endovascular Aortic Repair",[29,276,305,306,307,308],"FEVAR","Computed Tomography Imaging","CT","ECGgated","2026-03-16",{"date":311,"type":34},"2026-03-19",{"date":313,"type":22},"2026-04-01",{"date":315,"type":22},"2028-01-31",{"name":317,"class":41},"University of Twente",6,{"id":320,"slug":321,"hasResults":12,"nctId":322,"briefTitle":323,"officialTitle":323,"acronym":324,"eligibilityCriteria":325,"healthyVolunteers":104,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":326,"targetDuration":4,"studyType":23,"phases":328,"briefSummary":329,"conditions":330,"keywords":331,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":334,"startDateStruct":335,"completionDateStruct":337,"leadSponsor":339,"locationsCount":42},"100629317","early-phase-1-pet-imaging-of-mmp-activation-in-aaa-clinical-component-100629317","NCT07473102","PET Imaging of MMP Activation in AAA: Clinical Component","PET AAA","Inclusion Criteria: Healthy Volunteers\n\n* No history of claustrophobia or other preventing condition that has previously or would interfere with completion of protocol-specified imaging sessions.\n* Able to comprehend and willing to follow instructions for the study procedures as called for by the protocol.\n* Capable of lying still and supine within the PET\u002FCT scanner for \\~1 hour and follow instructions for breathing protocol during the CT portion.\n* No illicit drug use or other inhaled drug use (including pharmacologic agents, recreational agents, or illicit drugs) within the past year.\n* No known history of cardiac, pulmonary, hepatic or renal disease or diabetes\n* BMI ≤ 40\n\nExclusion Criteria: Healthy Volunteers\n\n* Inability to receive and sign informed consent;\n* Pregnant (confirmed by urine pregnancy test) and\u002For breastfeeding\n* Patient with chronic renal disease whose glomerular filtration rate (GFR) is less than 30 mL\u002Fmin\u002F1.73 m2\n* Patients with an unstable clinical condition that in the opinion of the principal investigators or designee precludes participation in the study.\n* Is deemed likely to be unable to perform all research procedures for any reason, (e.g., subjects unable to lie still or inability to tolerate up to 60 minutes in a supine position with arms up during the PET imaging procedures due to chronic back\u002Fshoulder pain or arthritis as assessed by physical examination and medical history).\n* Currently using recreational drugs.\n* Body weight of \\>300 lbs. (weight limit of the PET table).\n* Currently enrolled in another study using an investigational drug or underwent a study the last year involving investigational use of radiotracers or CT would confound results or with a radiation exposure when combined with this study would be deemed as excessive by the Sponsor-Investigator.\n\nInclusion Criteria: Patients with AAA electively or semi-electively scheduled for surgical repair\n\n* Men or women 40-80 years of age\n* Willing and able to provide informed consent\n* Medically managed hypertension and hyperlipidemia\n* No history of claustrophobia or other preventing condition that has previously or would interfere with completion of protocol-specified imaging sessions\n* Able to comprehend and willing to follow instructions for the study procedures as called for by the protocol\n* Patients with AAA indicated for surgical repair (5.0 \\[female\\] - 5.5cm \\[male\\]), incidentally identified large(r) AAAs (\\>5.5 or 6.0 cm), and rapidly expanding AAAs (\\> 0.5 cm in 6 months or \\> 1 cm in 12 months) per Guidelines of the Society for Vascular Surgery.\n\nExclusion Criteria: Patients with AAA electively or semi-electively scheduled for surgical repair\n\n* Inability to receive and sign informed consent.\n* Currently enrolled in another study using an investigational drug\n* Pregnant (confirmed by urine pregnancy test) and\u002For breastfeeding\n* Patient with chronic renal disease whose GFR is less than 30 mL\u002Fmin\u002F1.73 m2\n* Documented allergy to iodinated contrast and\u002For shellfish\n* Patients with an unstable clinical condition that in the opinion of the principal investigators or designee precludes participation in the study.\n* Inability to tolerate 60 minutes in a supine position with arms down at sides, as necessary for PET\u002FCT.\n* Other conditions such as symptomatic\u002Frecently treated coronary disease, cancer requiring oncologic management, or autoimmune\u002Finflammatory diseases (e.g., rheumatoid arthritis or multiple sclerosis).\n* Non-AAA volunteers may not carry a diagnosis of aortoiliac occlusive disease, as documented by their treating vascular surgeon, as significantly progressed atherosclerotic disease may demonstrate exaggerated, associated MMP activity.",{"count":327,"type":22},28,[158],"A first-in-human evaluation of \\[64Cu\\]-RYM2 with PET\u002FCT will be performed to: a) assess its safety, biodistribution, and radiation dosimetry in normal volunteers (WU) and; b) in AAA patients undergoing surgery (WU and Yale), evaluate radiotracer pharmacodynamics and correlate PET imaging characteristics (WU) with ex vivo tissue measurements (Yale).",[29],[332,333],"Imaging for Aneurysm Abdominal","Imaging for Abdominal Aneurysms",{"date":280,"type":34},{"date":336,"type":34},"2025-11-03",{"date":338,"type":22},"2027-03-31",{"name":340,"class":41},"Washington University School of Medicine",{"id":342,"slug":343,"hasResults":12,"nctId":344,"briefTitle":345,"officialTitle":346,"acronym":347,"eligibilityCriteria":348,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":349,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":351,"conditions":352,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":355,"lastUpdatePostDateStruct":356,"startDateStruct":358,"completionDateStruct":360,"leadSponsor":362,"locationsCount":364},"100381427","terumo-aortic-global-endovascular-registry-100381427","NCT04246463","Terumo Aortic Global Endovascular Registry","A Global Post Market Evaluation of Terumo Aortic Endovascular Grafts","TiGER","Inclusion Criteria:\n\n* Minimum age as per local regulations\n* Indication for aortic endovascular repair with an approved or CE marked by a Regulatory body or custom-made Terumo Aortic Endovascular graft\n* Ability to provide informed consent\n\n  o Emergent cases (typically younger patients with traumatic injuries) are not excluded if there is IRB\u002FEC agreement to allow consent after intervention (i.e. consent to study participation, not to treatment) or use of a Legally Authorized Representative (LAR).\n* Willingness to comply with the registry protocol\n* Willingness to adhere to follow-up visits Note: Patients currently enrolled and actively participating within the TREO registry (IP-0020-16) can have their data migrated from TREO to the TiGER registry where local EC approval has been obtained and the patient has been reconsented to TiGER for longer follow-up.\n\nExclusion Criteria:\n\nPatient is unable or unwilling to comply with the study follow-up regime. Patient is contraindicated per the IFU, or has any other medical, social or psychological problems that in the opinion of the investigator preclude them from receiving treatment as well as the procedures and evaluations pre and post procedure.",{"count":350,"type":22},1000,"Multi-arm, multi-center, open label, prospective observational registry designed to obtain safety and performance data on the use of CE marked and custom Terumo Aortic endovascular grafts.",[29,353,354],"Thoracic Aortic Aneurysm","Surgery","2026-03-10",{"date":357,"type":34},"2026-03-13",{"date":359,"type":34},"2019-12-17",{"date":361,"type":22},"2030-11",{"name":363,"class":96},"Vascutek Ltd.",58,{"id":366,"slug":367,"hasResults":12,"nctId":368,"briefTitle":369,"officialTitle":370,"acronym":4,"eligibilityCriteria":371,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":372,"targetDuration":374,"studyType":80,"phases":4,"briefSummary":375,"conditions":376,"keywords":380,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":386,"lastUpdatePostDateStruct":387,"startDateStruct":389,"completionDateStruct":391,"leadSponsor":393,"locationsCount":4},"100626085","fast-track-protocol-for-endovascular-aneurysm-repair-evar-of-infrarenal-abdominal-aortic-aneurysms-100626085","NCT07431047","Fast-Track Protocol for Endovascular Aneurysm Repair (EVAR) of Infrarenal Abdominal Aortic Aneurysms","Fast-Track Protocol for Infrarenal EVAR","Inclusion criteria\n\n* Patient diagnosed with infrarenal Abdominal Aortic Aneurysm (AAA) indicated for elective endovascular repair.\n* Patient diagnosed with Penetrating Aortic Ulcer (PAU) indicated for elective endovascular repair.\n* Patient resident in the Bologna metropolitan area OR able to remain within the area for at least 7 days post-procedure.\n* Patient with a cohabitant or caregiver available (cannot live alone) to ensure safety during the early post-discharge phase.\n* Signed informed consent specifically for local\u002Flocoregional anesthesia, the procedure and the specific fast-track pathway.\n* Common femoral arteries diameter \\> 7 mm\n* Common femoral arteries free of severe calcification (\\\u003C 50% of vessel circumference), suitable for percutaneous closure device\n* Proximal aortic neck length \\> 15 mm\n* Proximal aortic neck diameter \\\u003C 30 mm\n* Proximal aortic neck without severe angulation (\\\u003C60°) or circumferential thrombus \\\u003C50%\n\nExclusion Criteria:\n\n* Patient resident outside the Bologna metropolitan area or unable to remain within the area for at least 7 days post-procedure.\n* Patient without a cohabitant or caregiver available\n* Common femoral arteries diameter \\\u003C7 mm\n* Common femoral arteries with severe calcification (\\> 50% of vessel circumference), unsuitable for percutaneous closure device\n* Proximal aortic neck length \\\u003C 15 mm\n* Proximal aortic neck diameter \\> 30 mm\n* Proximal aortic neck with severe angulation (\\>60°) or circumferential thrombus \\>50%\n* General anesthesia\n* Open conversion\n* Medical contraindication to local\u002Flocoregional anesthesia or patient refusal\u002Finability to cooperate during the procedure.\n* Severe Chronic Kidney Disease (glomerular filtration rate \\> 30 ml\u002Fmin) requiring exclusively CO2 angiography\n* Ruptured or symptomatic aneurysms requiring emergency repair.\n* Clinical condition requiring intensive invasive monitoring (e.g., CVC, urinary catheter) prior to the procedure.",{"count":373,"type":22},50,"1 Year","The study aims to evaluate the clinical and economic efficacy of a \"Fast-Track\" protocol for the elective endovascular treatment (EVAR) of infrarenal abdominal aortic aneurysms (AAA). The protocol minimizes invasiveness through the use of local\u002Flocoregional anesthesia, a total percutaneous approach, and the avoidance of routine Intensive Care Unit (ICU) admission. The primary goal is to reduce hospital Length of Stay (LOS) to \\\u003C48 hours and decrease procedural costs, while maintaining safety and increasing patient turnover compared to the standard of care.",[29,377,378,379],"Infrarenal Abdominal Aortic Aneurysm","Penetrating Aortic Ulcers (PAUs)","Iliac Aneurysm",[381,382,383,384,385],"EVAR","Fast-track Surgery","Local Anesthesia","Percutaneous Access","Cost-Benefit Analysis","2026-02-20",{"date":388,"type":34},"2026-02-24",{"date":390,"type":22},"2026-02-11",{"date":392,"type":22},"2027-12-31",{"name":394,"class":41},"University of Bologna",{"id":396,"slug":397,"hasResults":12,"nctId":398,"briefTitle":399,"officialTitle":400,"acronym":401,"eligibilityCriteria":402,"healthyVolunteers":104,"sex":403,"minAge":404,"maxAge":405,"enrollmentInfo":406,"targetDuration":4,"studyType":23,"phases":407,"briefSummary":408,"conditions":409,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":410,"lastUpdatePostDateStruct":411,"startDateStruct":413,"completionDateStruct":415,"leadSponsor":417,"locationsCount":97},"100486688","screening-for-abdominal-aortic-aneurysms-in-the-general-practice-by-ultraportable-ultrasound-100486688","NCT05617326","Screening for Abdominal Aortic Aneurysms in the General Practice by Ultraportable Ultrasound","Screening for Abdominal Aortic Aneurysms in the General Practice by Ultraportable Ultrasound: Cluster Randomized Controlled Prospective Multicenter Study in Two Parallel Groups 1:1 in Open-label","DACEP","Inclusion Criteria:\n\n* Male\n* In the absence of a family history of AAA: Patient aged 65 to 75 years, chronic current or past smoker, active smoker (defined as having smoked at least one cigarette per day) or former smoker (defined as having quit smoking less than 20 years ago, regardless of the number of cigarettes smoked).\n* If there is a family history of AAA: Patient between 50 and 75 years of age\n* Express consent to participate in the study\n* Affiliated or beneficiary of a social security plan\n\nExclusion Criteria:\n\n* Patient with a legal protection measure\n* Patient with previous AAA screening less than 5 years old\n* Patient unable to understand the study \u002F give informed consent (cognitive impairment, communication impairment)","MALE","50 Years","75 Years",{"count":132,"type":22},[25],"Abdominal aortic aneurysm (AAA) is a localized dilatation of a segment of the aorta artery in its abdominal portion. It affects 1.7% of men aged 65 years and older. In the high-risk population (male smokers aged 65-75 years), its prevalence is estimated to be between 2.8 and 9%. Mortality of ruptured AAAs is high (80% of deaths before hospitalization or perioperatively), whereas mortality of scheduled procedures for unruptured AAAs is less than 5%. AAA screening has been shown to significantly reduce the specific mortality rate in the medium and long term. The French National Authority for Health (HAS) recommends targeted screening for AAA by ultrasound at the radiologist. The target population is male smokers or former smokers aged 65 to 75 years, as well as all persons aged 50 to 75 years with a family history of AAA. Despite recommendations, the rate of access to targeted screening appears low. Ultrasound screening for AAA is a rapid, noninvasive, and reproducible test. It relies primarily on the measurement of the maximum diameter of the abdominal aorta in cross-section. It has been demonstrated that the learning of the ultrasound screening procedure for AAA is very fast and that the performance of non-radiologists trained in this procedure alone is similar to that of radiologists.\n\nIn addition, new ultra-portable ultrasound devices, inexpensive and with validated performances have appeared on the market in the last few years, making it possible to equip general practitioners (GPs). We propose a simplified care pathway for AAA screening, by equipping GPs with an ultra-portable ultrasound scanner and by training them to perform the screening procedure, which will be performed in the office or at the patient's home, during a usual consultation of general medicine. Our hypothesis is that this new organization will allow better access to screening for the target population, at a lower cost, compared to the current screening method recommended by the HAS (referral of the patient to the radiologist).",[29],"2025-12-09",{"date":412,"type":34},"2025-12-17",{"date":414,"type":34},"2023-10-02",{"date":416,"type":22},"2027-09-01",{"name":418,"class":419},"Fondation Ophtalmologique Adolphe de Rothschild","NETWORK",{"id":421,"slug":422,"hasResults":12,"nctId":423,"briefTitle":424,"officialTitle":425,"acronym":426,"eligibilityCriteria":427,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":428,"targetDuration":4,"studyType":23,"phases":430,"briefSummary":431,"conditions":432,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":433,"lastUpdatePostDateStruct":434,"startDateStruct":435,"completionDateStruct":437,"leadSponsor":438,"locationsCount":42},"100594527","first-in-human-study-evaluating-aneurysm-sac-lining-in-aaa-patients-100594527","NCT07020611","First-In-Human Study Evaluating Aneurysm Sac Lining in AAA Patients","Aneurysm SaC ManagemENt Device for Abdominal Aortic Aneurysms First-in-Human (ASCEND) Study","ASCEND","Inclusion Criteria:\n\n* Patient can understand the purpose of the trial, voluntarily participate in the trial and sign the informed consent\n* Patient is willing to complete the follow-up according to the requirements of the protocol.\n* Patient AAA anatomy complies with \"instructions for use\" for commercial EVAR devices used\n* ≥18 years old\n* Abdominal aortic aneurysm with sac diameter ≥ 5.5cm in males and ≥ 5.0cm in females\n* Maximum blood flow luminal diameter ≤ 50mm\n* Eligible for endovascular aneurysm repair based on anatomical considerations, such as adequate iliac\u002Ffemoral access\n* Patient is American Society of Anesthesiology (ASA) grade 1 through 3, inclusive.\n\nExclusion Criteria:\n\n* Concomitant Common Iliac Artery aneurysms ≥ 25mm\n* Life expectancy \\\u003C2 years\n* Already participating in an investigational drug or device study\n* Known allergy or contraindication to any study device material\n* Coagulopathy or uncontrolled bleeding disorder\n* Ruptured, leaking, inflammatory or mycotic aneurysm\n* Connective tissue diseases (e.g., Marfan Syndrome)\n* Unsuitable vascular anatomy that may interfere with device introduction or deployment, in the opinion of the investigator\n* Aneurysmal or dissected disease of the descending thoracic aorta\n* Previous surgical or EVAR repair for AAA\n* Myocardial infarction and\u002For major heart surgery ≤ 90 days prior to the procedure\n* Transient Ischemic Attack or stroke ≤ 90 days prior to the procedure\n* Unstable angina or other active cardiac condition such as congestive heart failure, untreated or worsening atrial arrhythmia, ventricular arrhythmia or valvular disease ≤ 30 days prior to the procedure\n* Unable or unwilling to comply with study follow-up requirements\n* Serum creatinine level ≥ 180 µmol\u002FL\n* Patients of childbearing potential who are pregnant or planning to become pregnant during the course of the study\n* Patient has other medical, social or psychological problems that, in the opinion of the investigator, study involvement would not be in their best interest.",{"count":429,"type":22},15,[25],"The goal of this clinical trial is to evaluate the safety and feasibility of the Cygnum Aneurysm Sac Management Device in patients with abdominal aortic aneurysms treated with endovascular aneurysm repair (EVAR). The main questions it aims to answer are:\n\n1. Is the Cygnum device safe when used adjunctively with standard EVAR endografts?\n2. Does it effectively reduce or prevent type II endoleaks by managing the aneurysm sac?\n\nParticipants will:\n\n1. Undergo EVAR with adjunctive implantation of the Cygnum device\n2. Have follow-up imaging (e.g., CT scans) and clinical assessments to evaluate device position and sac behavior over time",[29],"2025-12-02",{"date":410,"type":34},{"date":436,"type":34},"2025-11-26",{"date":93,"type":22},{"name":439,"class":96},"Life Seal Vascular Inc.",{"id":441,"slug":442,"hasResults":12,"nctId":443,"briefTitle":444,"officialTitle":444,"acronym":4,"eligibilityCriteria":445,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":446,"targetDuration":4,"studyType":23,"phases":447,"briefSummary":448,"conditions":449,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":451,"startDateStruct":453,"completionDateStruct":455,"leadSponsor":457,"locationsCount":42},"100251186","estimation-of-biomechanical-aortic-wall-properties-in-healthy-and-aneurysmal-aortas-using-novel-imaging-techniques-100251186","NCT02548546","Estimation of Biomechanical Aortic Wall Properties in Healthy and Aneurysmal Aortas Using Novel Imaging Techniques","Inclusion Criteria:\n\n* Patients \\>18 years of age with ability to provide informed consent.\n* Patients with either symptomatic or asymptomatic AAA as defined by aortic diameter ≥ 1.5x normal diameter.\n* Patients with non-aneurysmal aortas who require aortic contrast imaging or echocardiography for preoperative planning or other reason.\n\nExclusion Criteria:\n\n* Patients with contraindication to IV contrast such as allergy or severe kidney dysfunction.\n* Patients who do not require contrast imaging or echocardiogram as part of their care plan.\n* Terminally ill patients, and patients with estimated life expectancy of ≤ 6 months.\n* Patients unable to tolerate magnetic resonance imaging.",{"count":106,"type":22},[25],"The primary aim of this study is to establish the practicality of using two novel imaging modalities for the assessment of biomechanical properties of the aorta.",[29],"2025-09-09",{"date":452,"type":34},"2025-09-11",{"date":454,"type":4},"2015-08",{"date":456,"type":22},"2026-08",{"name":458,"class":41},"Mayo Clinic",{"id":460,"slug":461,"hasResults":12,"nctId":462,"briefTitle":463,"officialTitle":464,"acronym":465,"eligibilityCriteria":466,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":467,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":469,"conditions":470,"keywords":4,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":471,"lastUpdatePostDateStruct":472,"startDateStruct":474,"completionDateStruct":476,"leadSponsor":478,"locationsCount":42},"100597284","rest4-aaa-registry-100597284","NCT07056491","REST4-AAA Registry","Serum REST4 as a Predictive Biomarker for Abdominal Aortic Aneurysm Progression","REST4 Registry","Inclusion Criteria:\n\n1. Presence of an infrarenal AAA with a maximum diameter of 39-49 mm;\n2. Han nationality;\n3. Between 50 years or more, no gender limit;\n4. No mental illness;\n5. Subjects voluntarily participate in this study, sign an informed consent form, have good compliance, and cooperate with follow-up.\n\nExclusion Criteria:\n\n1. Previous infrarenal aortic surgery;\n2. Planned major surgery;\n3. Known aortic dissection;\n4. Have received any other clinical trial treatment within 1 year;\n5. Systemic treatment with corticosteroids or other systemic immunomodulatory therapy;\n6. Severe infections, including but not limited to infections requiring hospitalization, bacteremia, severe pneumonia, etc.;\n7. Known or suspected inherited connective tissue disorder;\n8. Known or suspected prostate cancer;\n9. Calculated creatinine clearance of less than 30 ml\u002Fmin;\n10. Known significant liver disease;\n11. Known human immunodeficiency virus infection at the time of screening；\n12. Serious concomitant illness associated with life expectancy of less than 2 years；\n13. Any other significant and unstable condition that could limit compliance with the trial protocol.",{"count":468,"type":22},70,"This prospective observational study aims to investigate whether serum REST4 concentration can serve as a quantitative indicator correlated with abdominal aortic aneurysm (AAA) diameter and a predictive biomarker for AAA progression and rupture risk. Emerging evidence suggests that REST4, a splice variant of the RE-1 Silencing Transcription Factor (REST), is upregulated in vascular smooth muscle cells during AAA pathogenesis and may be released into circulation via exosomes. The study will enroll patients with asymptomatic AAA (diameter between 39-49 mm) and measure baseline serum REST4 levels, analyzing their association with morphological severity (maximum aortic diameter) and clinical outcomes (aneurysm growth rate, rupture and related mortality) through a 5-year follow-up period.",[29],"2025-06-29",{"date":473,"type":34},"2025-07-09",{"date":475,"type":22},"2025-07-01",{"date":477,"type":22},"2031-07-01",{"name":479,"class":41},"RenJi Hospital",{"id":481,"slug":482,"hasResults":12,"nctId":483,"briefTitle":484,"officialTitle":485,"acronym":4,"eligibilityCriteria":486,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":487,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":488,"conditions":489,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":491,"lastUpdatePostDateStruct":492,"startDateStruct":494,"completionDateStruct":496,"leadSponsor":498,"locationsCount":42},"100596005","aaa-cta-cohort-registry-100596005","NCT07039825","AAA-CTA Cohort Registry","Abdominal Aortic Aneurysm CTA Cohort Study (AAA-CTA Registry)","Inclusion Criteria:\n\n1. Patients with abdominal aortic aneurysm who visited the study hospital.\n2. Patients included should have computed tomography angiography data.\n\nExclusion Criteria:\n\n1\\. Patients who declined participation, cases with incomplete or missing clinical data.",{"count":350,"type":22},"The aim of this study is to investigate the measurement of abdominal aortic aneurysm by computed tomography angiography. The research will collected the results of computed tomography angiography from inpatient, emergency, and outpatient populations with abdominal aortic aneurysm.",[29,490],"Image","2025-06-18",{"date":493,"type":34},"2025-06-26",{"date":495,"type":34},"2020-01-01",{"date":497,"type":22},"2027-05-01",{"name":479,"class":41},{"id":500,"slug":501,"hasResults":12,"nctId":502,"briefTitle":503,"officialTitle":504,"acronym":505,"eligibilityCriteria":506,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":507,"targetDuration":509,"studyType":80,"phases":4,"briefSummary":510,"conditions":511,"keywords":513,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":518,"lastUpdatePostDateStruct":519,"startDateStruct":521,"completionDateStruct":523,"leadSponsor":524,"locationsCount":42},"100385536","italian-multicenter-database-for-open-conversions-after-evar-100385536","NCT04299984","Italian Multicenter Database for Open Conversions After EVAR","Italian Multicenter Prospective Database for Open Conversions and SemiConversions After Endovascular Aneurysm Repair","iConveRt","Inclusion Criteria:\n\n* open or laparoscopic surgery for EVAR complications, with or without endograft explantation\n\nExclusion Criteria:\n\n* endovascular reinterventions\n* extra-anatomical bypass surgery (e.g. femoro-femoral crossover bypass) not associated with direct aorta\u002Fendograft surgery",{"count":508,"type":22},500,"5 Years","Late endovascular abdominal aneurysm repair (EVAR) complications not amenable to endovascular correction can undergo either late open conversion (LOC) or semi-conversion (SC).\n\nLOC is defined as a total or partial endograft explantation \\>30 days after the initial EVAR.\n\nSC is defined as open or laparoscopic surgery for endoleak (EL) correction with complete endograft preservation.\n\nThe aim of this study is to collect in a prospective database the technical aspects of a multicenter experience of LOC and SC, and to analyse early and long-term outcomes of these two treatments.",[29,512],"Abdominal Aortic Aneurysm Enlargement",[275,514,515,516,517],"Open surgical conversion","Endovascular repair","EVAR explantation","Failed EVAR","2025-05-29",{"date":520,"type":34},"2025-06-04",{"date":522,"type":34},"2022-01-01",{"date":144,"type":22},{"name":525,"class":41},"Azienda Ospedaliero-Universitaria di Parma",{"id":527,"slug":528,"hasResults":12,"nctId":529,"briefTitle":530,"officialTitle":531,"acronym":532,"eligibilityCriteria":533,"healthyVolunteers":104,"sex":18,"minAge":534,"maxAge":535,"enrollmentInfo":536,"targetDuration":4,"studyType":23,"phases":538,"briefSummary":539,"conditions":540,"keywords":544,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":551,"lastUpdatePostDateStruct":552,"startDateStruct":554,"completionDateStruct":556,"leadSponsor":558,"locationsCount":560},"100591496","equita---a-feasibility-trial-of-a-faith-placed-intervention-to-increase-screening-uptake-in-black-adults-100591496","NCT06981182","EQUITA - A Feasibility Trial of a Faith-placed Intervention to Increase Screening Uptake in Black Adults","EQUITy in Black Adult Health (EQUITA) - a Randomised Feasibility Trial of a Co-produced and Faith-placed Intervention to Increase Uptake of Breast, Cervical, Bowel, and AAA Screening in the North East of England, Leeds and Scotland","EQUITA","Inclusion Criteria:\n\n* Members of participating churches (North East of England, Leeds, Scotland)\n* Self-identify as Black,\n* Female aged 25-74,\n* Male aged 50-74,\n* Not up to date with all screening tests for which they are eligible, e.g., women who are up to date with one form of screening (e.g., breast) will be eligible for recruitment if they are not up to date with others (e.g., cervical or bowel).\n\nExclusion Criteria:\n\n* Not a member of participating churches (North East of England, Leeds, Scotland).\n* Individuals who do not self-identify as Black\n* Do not self-identity as Black\n* Females aged outside the range of 25-74\n* Males aged outside the range of 50-74.\n* Individuals who are up to date with all screening tests for which they are eligible.","25 Years","74 Years",{"count":537,"type":22},300,[25],"The goal of this randomised feasibility trial is to examine feasibility and acceptability of a co-produced and faith-placed intervention to increase uptake of breast, cervical, bowel, and abdominal aortic aneurysm (AAA) screening among Black communities in the North East of England, Leeds and Scotland, United Kingdom (UK).\n\nParticipants will be invited to attend a two-hour workshop at each of the three study sites and will be randomly assigned to either the intervention group or the control group.\n\nThis 24-month feasibility study will inform the development of a full-scale randomised-controlled trial co-produced for Black people that uses culturally appropriate messages that support screening for early diagnosis in this underserved group.",[541,542,543,29],"Breast Cancer","Bowel Cancer","Cervical Cancer",[545,541,542,543,29,546,547,548,549,550],"Cancer screening","Faith-placed intervention","Black adults","Randomised Controlled Trial","Feasibility study","Faith-based","2025-05-12",{"date":553,"type":34},"2025-05-20",{"date":555,"type":22},"2025-09-01",{"date":557,"type":22},"2027-02-28",{"name":559,"class":41},"University of Sunderland",3,{"id":562,"slug":563,"hasResults":12,"nctId":564,"briefTitle":565,"officialTitle":566,"acronym":567,"eligibilityCriteria":568,"healthyVolunteers":12,"sex":18,"minAge":404,"maxAge":569,"enrollmentInfo":570,"targetDuration":4,"studyType":23,"phases":572,"briefSummary":573,"conditions":574,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":575,"lastUpdatePostDateStruct":576,"startDateStruct":578,"completionDateStruct":580,"leadSponsor":582,"locationsCount":42},"100400939","phase-2-limiting-aaa-with-metformin-limit-trial-100400939","NCT04500756","Limiting AAA With Metformin (LIMIT) Trial","LIMItIng AAA With meTformin (LIMIT) Trial","LIMIT","7.2 Inclusion Criteria\n\n1. Provision of signed and dated informed consent;\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Male or female, aged 50 to 95 years inclusive;\n4. Have a maximal orthogonal infrarenal aortic diameter between 35 and \\\u003C 50 mm for males and between 30 and \\\u003C 45 mm for females as measured by CTA;\n5. Eligible participants must have an estimated glomerular filtration rate (eGFR) of ≥ 30 ml\u002Fmin\u002F1.73 m2 at the initiation of trial participation, and must remain ≥ 30 ml\u002Fmin\u002F1.73 m2 throughout the term of the study to continue participation;\n6. HgbA1c must be ≤ 6.5% at initiation to receive study medication;\n7. Ability to take oral medication and be willing to adhere to the medication regimen throughout the course of the trial;\n8. Must be willing and able to undergo two computed tomographic aortograms (CTA, with timed intravenous iodinated contrast injections if possible) at initiation and termination of study participation;\n9. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening, with an agreement to use such a method of contraception during study participation and for an additional 4 weeks after the end of study drug administration.\n\n7.3 Exclusion Criteria 1. Diagnosis of, or taking medications for, diabetes mellitus, as defined as HgbA1c \\> 6.5% at baseline evaluation; 2. Known hypersensitivity to metformin hydrochloride. Individuals with known prior anaphylactic reaction to iodinated contrast will have the option of CT scan without contrast or will not be eligible to participate. Individuals with a prior allergic reaction not including anaphylaxis will be managed with the standard CT protocol for premedication for allergy to contrast - 3 doses of prednisone (50 mg p.o. per) beginning 13 hours prior to the procedure as well as 50 mg of Benadryl p.o. Premedication start times are as follows: 13 hours before contrast, 50 mg PO prednisone 7 hours before contrast, 50 mg PO prednisone\n\n1 hour before contrast, 50 mg PO prednisone + 50 mg PO diphenhydramine These individuals will also be given the option of CT scan without contrast if unwilling to follow the premedication as indicated above; 3. Presence of metabolic acidosis, defined as total CO2 below the lower limit of normal on chemistry panel obtained during determination of study eligibility; 4. Expected survival less than two years; 5. Prior surgical AAA repair, or anticipated repair within two years; 6. Known thoracic aortic aneurysm disease, as defined as a prior dissection or thoracic aortic diameter \\> 5 cm); 7. The presence of known syndromic aortic conditions, including but not limited to Ehlers Danlos or Marfan Syndromes, or the at-risk allele in the ACTA2 gene mutation or similar conditions; 8. Severe liver disease, jaundice, or active hepatitis; 9. Severe anemia, defined as a Hgb \\\u003C 10g\u002Fdl; 10. Concurrent participation in other investigational drug trials; 11. For female participants of childbearing potential: pregnancy, intent to become pregnant, lactation, or unwilling or unable to use an effective method of contraception; 12. Alcoholism or chronic excessive alcohol intake; 13. Common iliac artery aneurysms \\> 3.5 cm; 14. Uncontrolled hypertension defined as Systolic BP≥200, or considered to have hypertensive emergency or urgency.","95 Years",{"count":571,"type":22},314,[134],"In this research, the investigators are looking at the effects of a drug called metformin may have on the growth of abdominal aortic aneurysm (AAA)s. AAA is an abnormal enlargement of the aorta, which is the large artery in the abdomen (stomach area). The enlargement of the aorta carries a risk that it will rupture and cause life-threatening bleeding in the abdomen (belly). In this study the investigators hope to learn how metformin is associated with the enlargement or change in size of the AAA in study participants. Smaller studies have suggested that metformin may reduce the rate at which aortic aneurysms enlarge. This study will test this question: does metformin prevent AAAs from growing larger?",[29],"2025-04-15",{"date":577,"type":34},"2025-04-18",{"date":579,"type":34},"2022-02-28",{"date":581,"type":22},"2028-06-30",{"name":583,"class":41},"Stanford University",{"id":585,"slug":586,"hasResults":12,"nctId":587,"briefTitle":588,"officialTitle":588,"acronym":589,"eligibilityCriteria":590,"healthyVolunteers":104,"sex":18,"minAge":217,"maxAge":4,"enrollmentInfo":591,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":593,"conditions":594,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":595,"lastUpdatePostDateStruct":596,"startDateStruct":598,"completionDateStruct":600,"leadSponsor":602,"locationsCount":42},"100238835","magnetic-resonance-elastography-in-patients-with-abdominal-aortic-aneurysms-100238835","NCT02387255","Magnetic Resonance Elastography in Patients With Abdominal Aortic Aneurysms","AAA-MRE","Inclusion Criteria:\n\n* Must be able to lie flat on their back in the scanner for up to 60 minutes\n* Must be able to hold breath for up to 15 seconds\n\nExclusion Criteria:\n\n* Patients who are claustrophobic\n* Patients who are pregnant\n* Patients with any unapproved, non-MRI save metal\u002Fdevices in or on their body",{"count":592,"type":22},165,"The main objective of this study is to utilize Magnetic Resonance Elastography (MRE) to determine tissue stiffness of abdominal aortic aneurysms (AAA). For patients with AAA, MRE is a more sensitive and superior method of determining the risk for rupture of AAA based on stiffness estimates when compared to the current, crude method of assessing risk based on measurement of the diameter of the aneurysm. The investigators will also validate the stiffness estimates against gold standard i.e. mechanical testing and histopathology only AAA patients undergoing AAA surgery.",[29],"2025-04-04",{"date":597,"type":34},"2025-04-08",{"date":599,"type":4},"2014-10",{"date":601,"type":22},"2028-10-31",{"name":603,"class":41},"Ohio State University",{"id":605,"slug":606,"hasResults":12,"nctId":607,"briefTitle":608,"officialTitle":609,"acronym":610,"eligibilityCriteria":611,"healthyVolunteers":12,"sex":612,"minAge":404,"maxAge":4,"enrollmentInfo":613,"targetDuration":4,"studyType":23,"phases":615,"briefSummary":616,"conditions":617,"keywords":618,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":622,"lastUpdatePostDateStruct":623,"startDateStruct":625,"completionDateStruct":626,"leadSponsor":628,"locationsCount":4},"100546387","early-endovascular-repair-versus-surveillance-for-women-with-small-abdominal-aortic-aneurysm-100546387","NCT06394271","Early Endovascular Repair Versus Surveillance for Women With Small Abdominal Aortic Aneurysm","WARRIORS Trial and Registry","WARRIORS","Inclusion Criteria:\n\n* female sex\n* age ≥50 years\n* infra-renal abdominal aortic aneurysm with a maximum infrarenal aortic anterior-posterior diameter 4.0-5.4 cm, aneurysm, measured on ultrasonography or the centreline orthogonal diameter on Computed Tomography (CT) scan when this is the discovery imaging mode,\n* Local assessment that arterial morphology is suitable for EVAR within manufacturer's IFU for any licensed infrarenal endograft, including those with concomitant common iliac aneurysm(s), provided the device is landed in the iliac arteries, without coverage of patent internal iliac arteries.\n* Rockwood frailty score \\\u003C7.\n\nExclusion Criteria:\n\n* Male sex\n* aneurysm of the infrarenal aorta of \\\u003C4.0 or \\>5.4cm\n* infrarenal aneurysm not meeting IFU for any specific licensed endograft for standard EVAR\n* inability to give informed consent\n* previous abdominal aortic surgery\n* age \\\u003C50 years\n* concomitant thoracic aortic aneurysm of \\>4.0cm diameter\n* excessive frailty (Rockwood frailty score 7 or more)\n* life expectancy \\\u003C2 years (in the opinion of the site principal investigator)\n* severe contrast allergy not amenable to steroid\u002Fantihistamine pretreatment (e.g., anaphylaxis)\n* those considered unlikely to comply with follow-up\n* concomitant common iliac artery aneurysm unless: a) the arterial morphology is within the IFU for standard infrarenal EVAR; or b) the arterial morphology is suitable for a licensed iliac branch device; or c) the internal iliac artery is occluded and the stent limb can be landed in the external iliac artery without embolization of the internal iliac artery.\n\nThere will be no patient excluded as a result of geographical location, disability, gender, marriage and civil partnership status, ethnicity, religion or belief, sexual orientation, socioeconomic status or access to health or social care.","FEMALE",{"count":614,"type":22},1112,[25],"Elective Abdominal Aortic Aneurysm (AAA) repair is offered when the risk of rupture exceeds the risk of surgery. Women (versus men) have a four-fold higher risk of AAA rupture but almost double the operative mortality. It is unknown whether the current 5.5cm diameter AAA repair threshold, derived from randomised trials including only 4% women, is applicable to women.\n\nTherefore, should women have their aneurysms repaired electively at smaller diameters than men to improve their AAA-related survival and quality of life? WARRIORS is an international randomised controlled trial of early elective endovascular repair versus routine surveillance in women (n=1112) with small asymptomatic AAA (4-5.4cm diameter), nested within a registry of non-participants. The surveillance group will be offered repair for rupture or upon reaching the 5.5cm threshold. Randomisation will be 1:1 stratified by country, age, and aneurysm diameter. The trial is powered for aneurysm-related mortality or rupture at 5 years. Quality-Adjusted-Life-Years is a major secondary outcome. Other outcomes include: operative mortality and complications, anxiety, major cardiovascular adverse events, and cost-effectiveness. Quality-of-life and anxiety questionnaires and \"standard-of-care\" using routine data will be collected.\n\nThe trial aims to progress health equity through provision of evidence for sex-specific clinical guidelines for AAA repair.",[29],[619,620,621,192],"abdominal aortic aneurysm","women's health","intervention threshold","2025-03-17",{"date":624,"type":34},"2025-03-20",{"date":475,"type":22},{"date":627,"type":22},"2034-04-30",{"name":629,"class":41},"Imperial College London",{"id":631,"slug":632,"hasResults":12,"nctId":633,"briefTitle":634,"officialTitle":635,"acronym":636,"eligibilityCriteria":637,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":638,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":640,"conditions":641,"keywords":643,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":645,"lastUpdatePostDateStruct":646,"startDateStruct":648,"completionDateStruct":650,"leadSponsor":652,"locationsCount":654},"100376584","tonometry1-and-duplex-ultrasound2-to-predict-cv-events-in-to-be-treated-patients-with-an-aaa-100376584","NCT04183426","Tonometry(1) and Duplex Ultrasound(2) to Predict CV Events in to be Treated Patients With an AAA","Tonometry(1) and Duplex Ultrasound(2) to Predict Cardiovascular Events in to be Treated Patients With an Abdominal Aortic Aneurysm (One-Two-Treat Trial)","One-Two-Treat","Inclusion Criteria:\n\n* Male or female at least 18 years old;\n* Informed consent form understood and signed and patient agrees to follow- up visits;\n* Has an infrarenal or juxtarenal abdominal aortic aneurysm (AAA), scheduled for elective repair (i.e open repair, EVAR, FEVAR and CHEVAR) according to standard practice;\n\nExclusion Criteria:\n\n* Life expectancy \\\u003C 2 years;\n* Psychiatric or other condition that may interfere with the study;\n* Participating in another clinical study, interfering on outcomes;\n* Increased risk for coronary spasms (score Rose-questionnaire ≥2;\n* Presence of Raynaud's phenomenon, Marfan syndrome, chronic pain syndrome at upper extremity(s), presence of an AV fistula or shunt, open wounds to the upper extremity(s), and\u002For scleroderma associated with placing the hand in ice water;\n* Recent (\\\u003C3 months) presence of angina pectoris, myocardial infarction, cerebral infarction, and\u002For heart failure, or PAD treatment.",{"count":639,"type":22},194,"Abdominal aortic aneurysm (AAA) is a common vascular disease and associated with risk of rupture, but also with a high cardiovascular (CV) event rate. A key difficulty in AAA is predicting these life-threatening complications, which are strongly linked to vascular health. In 2013, the SMART risk score was developed to calculate the risk of the patients for recurrent vascular events based on clinical characteristics. Recently, a novel, easy to perform, non-invasive test of endothelial function (the carotid artery reactivity (CAR) test), reflecting target organ damage, has been introduced. The CAR is a simple, quick (5-min), non-invasive test that uses ultrasound to examine the carotid artery in response to sympathetic stimulation by placing one hand in cold water. This test shows strong agreement with both coronary and aortic responses to sympathetic stimulation and predicted CV-events in patients with peripheral arterial disease.\n\nThe aim of this prospective 2-year follow-up study is to investigate the predictive capacity of the CAR-test for development of CV-events after elective AAA repair in comparison to the SMART risk score. Secondary objectives are to investigate the predictive capacity of arterial stiffness measurements and the post-operative CAR-test for development of CV-events and to evaluate health status scores to provide insight if these scores can support clinical decision making.",[29,642],"Cardiovascular Events",[644,29,642],"Functional Response","2025-03-03",{"date":647,"type":34},"2025-03-06",{"date":649,"type":34},"2020-06-12",{"date":651,"type":22},"2027-06",{"name":653,"class":41},"Rijnstate Hospital",7]