[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"abdominal-aortic-aneurysms\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:abdominal-aortic-aneurysms":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,69],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100610180","physician-modified-endografts-for-complex-aortic-aneurysms-and-thoracoabdominal-aneurysm-repair-in-high-risk-patients-100610180",false,"NCT07224230","Physician-Modified Endografts for Complex Aortic Aneurysms and Thoracoabdominal Aneurysm Repair in High-Risk Patients","PMEG","Inclusion Criteria:\n\n* Patient is \\> 18 years of age.\n* Patients who are male or non-pregnant female (females of childbearing potential must have a negative pregnancy test prior to enrollment into the study)\n* Patient is able and willing to sign an Institutional Review Board (IRB) approved Informed Consent Form\n* The subject has at least one of the following:\n\n  1. . An aortic or aortoiliac aneurysm with a maximum diameter of ≥ 5.5cm for males, ≥ 5.0cm for females\n  2. Aortic Aneurysm with a history of growth ≥ 0.5 cm in 6 mos.\n  3. Symptomatic aneurysm\n  4. Morphology such as saccular aneurysms\n  5. Aneurysms meeting any of the above criteria a-e above or below the previous endovascular and\u002For open aortic repairs. Previously placed aortic stent graft or open aortic grafts may serve as seal zones.\n* Cannot be treated with a currently available non-modified approved device.\n* Patient has patent iliac or femoral arteries that will allow endovascular access with the physician modified graft or is suitable for an iliac conduit.\n* Patient has a suitable non-aneurysmal proximal aortic neck length (seal zone) of ≥ 20mm.\n* Patient has a suitable non-aneurysmal distal iliac artery length (seal zone) of ≥15mm.\n* The resultant repair should preserve patency in at least one hypogastric artery.\n* Patient has suitable non-aneurysmal distal common iliac diameters between 7 and 20mm.\n* Chronic Dissection with aneurysmal degeneration that meets size criteria as described above for repair\n* Type 1A endoleak requiring extension above the previous repair into the pararenal or paravisceral portion of the aorta to achieve 2 cm of seal.\n\nExclusion Criteria:\n\n* patient has a mycotic aneurysm\n* patient has a systemic or local infection that may increase the risk of graft infection.\n* Body habitus that would inhibit x-ray visualization of the aorta or exceeds the safe capacity of the equipment.\n* Subject has had a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned \\\u003C 30 days of the endovascular repair.\n* Patient is currently participating in another investigational device or drug clinical trial.\n* Eligible for treatment with FDA-approved marketed device\n* Can enroll in a manufacturer-sponsored clinical study at our institution or is willing and eligible to participate in a study with a manufacturermade device at another institution.\n* Unwilling to comply with the follow-up schedule.\n* Inability or refusal to give informed consent by subject or legal representative. - The subject is pregnant or breastfeeding.\n* Known sensitivities or allergies to the materials of construction of the devices, including stainless steel, polyester, polypropylene, nickel, titanium, or gold. - Known hypersensitivity or contraindication to anticoagulation or contrast media that is not amenable to pretreatment\n* Uncorrectable coagulopathy\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* History of connective tissue disorders (e.g., Marfan Syndrome, Ehlers's Danlos Syndrome) without landing zone created from graft via previous open repair. - Patient has active malignancy with life expectancy of less than 2 years.\n* Patient has a limited life expectancy of less than 2 years.\n* Patient has other medical, social, or psychological conditions that, in the opinion of the investigator, preclude them from receiving the pretreatment, required treatment, and post-treatment procedures and evaluations.\n* Anatomical exclusion criteria such as significant occlusive disease, tortuosity or calcification that would prevent endovascular access.\n* proximal seal site with a circumferential thrombus\u002Fatheroma\n* inability to maintain at least one hypogastric artery.\n* shaggy aorta\n* patient is not amenable to a temporary or permanent open surgical or endovascular conduit.\n* Thrombus or excessive calcification within the neck of the aneurysm","ALL","18 Years",{"count":19,"type":20},15,"ESTIMATED","INTERVENTIONAL",[23],"NA","This single-arm FDA-monitored protocol intends to broaden endovascular device applicability using physician-modifications in patients who A) Have anatomical conditions not amenable to endovascular repair using currently marketed grafts in the United States. B) Are at high risk for open surgical repair. C) Are high-risk subjects with previously placed endovascular devices and have developed failure of their previous devices. The use of physician-modified endografts aims to shift the seal zone proximally above the celiac artery in order to treat their complex or thoracoabdominal aneurysms in a minimally invasive fashion. These patients are considered too high risk to survive open surgical repair and do not meet anatomic criteria for the Gore Thoracoabdominal Multi Branch Endoprosthesis, which is currently the only FDA approved device in the US to treat these aneurysms.\n\nThe primary objective is to evaluate safety and effective of physician modified endografts in the treatment of thorax-abdominal aneurysms and complex aortic aneurysms. For primary safety endpoints, mortality and major adverse events (MAE) will be analyzed at 30 days or in hospitalization (if this exceeds 30 days). Primary endpoints include the following: 1. Mortality related to primary aortic disease 2. Aneurysm rupture 3. All cause mortality\n\nFor primary effectiveness endpoints, treatment success will be analyzed as the proportion of patients to achieve treatment success at 12 months. Treatment success is defined by a composite endpoint, which includes all of the following criteria: Technical success (defined as successful delivery and deployment of the physician modified endograft with perseveration of those branch vessels intended to be preserved, freedom from type I or type III endoleak, freedom from stent graft migration, freedom from aneurysm enlargement \\>5mm, freedom from aneurysm rupture or conversion to open repair.\n\nSecondary objectives of the study include assessment of individual safety and effectiveness endpoints as follows: technical success, procedure success, mortality, major adverse events - specifically renal, cardia, pulmonary, gastrointestinal, and neurologic. Each endpoint will be analyzed separately. Secondary endpoints will be individually analyzed at 4-8 weeks, 6 months, and annually at 1,2,3,4, and 5 years.\n\nSecondary endpoints to be analyzed are the following: 1. Evidence of Aortic Disease Progression: Monitoring for aneurysm growth \\> 5 mm from baseline measurements. 2. Device Failure: Evaluation of device performance, including migration \\> 10 mm, device degradation, and loss of device integrity. 3. Endoleaks: Monitoring for the occurrence and classification of endoleaks as outlined in the clinical outcome definitions. 4. Secondary Interventions: Description and analysis of secondary interventions aimed at treating branch vessel stenosis, occlusion, or embolization. 5. Significant Lifestyle-Limiting or Disabling Complications: Assessment and reporting of complications resulting in significant impairment of daily life, such as stroke-induced paralysis (paraplegia). 6. Cardiac Dysfunction: Monitoring and analysis of cardiac events, including myocardial infarction, congestive heart failure, and cardiac ischemia requiring intervention. 7. Renal Events: Evaluation of renal complications, including the need for dialysis, deterioration of renal function, and renal failure. 8. Mesenteric Events: Description and classification of mesenteric complications, such as ischemia and the need for surgical resection. 9. Respiratory Events: Monitoring for respiratory complications, including respiratory failure and prolonged intubation\n\nSecondary endpoints will be individually analyzed at 4-8 weeks, 6 months, and annually at 1,2,3,4, and 5 years",[26,27,28],"Abdominal Aortic Aneurysms","Thoracoabdominal Aneurysms","Pararenal Aortic Aneurysm",[14,30,31,32],"abdominal aortic aneurysms","thoracoabdominal aneurysms","pararenal aortic aneurysms","RECRUITING","2026-01-19",{"date":36,"type":37},"2026-01-21","ACTUAL",{"date":39,"type":37},"2025-09-01",{"date":41,"type":20},"2030-09-01",{"name":43,"class":44},"Steven Maximus","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":14,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":56,"conditions":57,"keywords":58,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":45},"100173930","physician-modified-endovascular-grafts-100173930","NCT01538056","Physician Modified Endovascular Grafts","Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Juxtarenal Aortic Aneurysm: An Investigator Initiated Study","Inclusion Criteria:\n\nAll patients must meet all of the following inclusion criteria to be eligible for enrollment into this study:\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: Abdominal aortic aneurysm \\>5.5 cm in diameter, Aneurysm has increased in size by 0.5 cm in last 6 months, Maximum diameter of aneurysm exceeds 1.5 times the transverse dimension of an adjacent non-aneurysmal aortic segment\n5. Patient has appropriate iliac\u002Ffemoral artery anatomy for access, with or without the use of a conduit, that will allow endovascular access with the physician modified endovascular graft.\n6. Patient has a suitable non-aneurysmal proximal aortic neck length 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 \\>15 mm. 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 32mm, 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 \\\u003C 60º\n11. Patient must be willing to comply with all required follow-up exams\n\nExclusion Criteria:\n\nPatients that meet ANY of the following are not eligible for enrollment into the study:\n\n1. Patient has a mycotic aneurysm or has an active systemic 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 planned within +\u002F- 30 days of the AAA repair.\n4. Patient has history of 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 a known allergy or intolerance stainless steel or gold\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. Subject is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site",{"count":54,"type":20},500,[23],"The primary objectives of this study are to determine whether physician modified endovascular grafts (PMEG) and specified company manufactured investigational devices are a safe and effective method of treating patients with elective, symptomatic or ruptured juxtarenal aortic aneurysms in those patients considered to have limited or no other options for treatment. Secondary objectives include the validation of a patient-specific, 3-D printed aortic template as a surgical planning tool for fenestrated endografting.",[26],[59],"AAA","2026-01-08",{"date":62,"type":37},"2026-01-12",{"date":64,"type":4},"2011-03",{"date":66,"type":20},"2055-01",{"name":68,"class":44},"University of Washington",{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":76,"targetDuration":78,"studyType":79,"phases":4,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":92},"100439573","vitaa-registry-pre--and-post-operative-monitoring-for-endovascular-aortic-aneurysm-repair-and-serial-monitoring-for-aaa-100439573","NCT05004051","ViTAA Registry Pre- and Post-Operative Monitoring for Endovascular Aortic Aneurysm Repair and Serial Monitoring for AAA","Prospective Registry Study to Collect Imaging and Clinical Data on Patients With Aortic Aneurysm Disease Undergoing Serial Monitoring & Pre and Post Endovascular Repair","Inclusion Criteria:\n\n1. Patient is aged 18 years or over\n2. Infrarenal Aortic Aneurysm ≥ 45 mm in diameter.\n3. Patient meets on-IFU criteria for endovascular reconstruction\n\nExclusion Criteria:\n\n1. Patient has a known or clinically suspected major connective tissue disorder, autoimmune disorder, vasculitis, or aortic dissection.\n2. Patient has renal failure (defined as dialysis dependent or serum creatinine ≥2.0mg\u002FdL or 175umol\u002FL\n3. Patients with previous aortic reconstruction in the involved segment.\n4. Patients receiving oral or parenteral corticosteroid therapy for other unrelated disease. (Excludes inhaled corticosteroids).\n5. Patient has a sensitivity to contrast imaging agents.\n6. Patient has aortic dissection.\n7. Patient has atrial fibrillation.\n8. Patient has arrhythmia.",{"count":77,"type":20},200,"12 Months","OBSERVATIONAL","This is a Prospective Registry study to collect imaging and clinical data both on patients with aortic aneurysm disease undergoing serial monitoring and on patients pre and post-endovascular repair, using ViTAA (The Sponsor) aortic mapping technology.",[26],"2025-09-15",{"date":84,"type":37},"2025-09-19",{"date":86,"type":37},"2021-12-15",{"date":88,"type":20},"2026-12-31",{"name":90,"class":91},"ViTAA Medical Solutions","INDUSTRY",8]