[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pararenal-aortic-aneurysm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pararenal-aortic-aneurysm":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,39,67,94],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":20,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100604288","tambe-japan-post-marketing-surveillance-100604288",false,"NCT07147569","TAMBE Japan Post-Marketing Surveillance","GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis Post-Marketing Surveillance","Inclusion Criteria:\n\n* Patients who were attempted to implant the AC\n* Thoracoabdominal aortic aneurysm\n* Pararenal abdominal aortic aneurysm\n\nExclusion Criteria:\n\n* N\u002FA","ALL",{"count":18,"type":19},100,"ESTIMATED","60 Months","OBSERVATIONAL","To evaluate the safety and efficacy of multi component system (TAMBE device) including GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (Aortic Component; AC) under post-marketing use.",[24,25],"Thoracoabdominal Aortic Aneurysm","Pararenal Aortic Aneurysm","RECRUITING","2026-05-04",{"date":29,"type":30},"2026-05-05","ACTUAL",{"date":32,"type":30},"2026-03-27",{"date":34,"type":19},"2034-02-28",{"name":36,"class":37},"W.L.Gore & Associates","INDUSTRY",5,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":66},"100465311","physician-modified-endograft-for-complex-aortic-aneurysm-repair-100465311","NCT05339061","Physician Modified Endograft For Complex Aortic Aneurysm Repair","A Single-Arm, Single-Center, Non-Randomized, Prospective Clinical Study to Evaluate the Safety and Effectiveness of Physician Modified Endograft for Complex Abdominal and Thoracoabdominal Aortic Aneurysm Repair","---Inclusion criteria---\n\n1. Patient is \\> 18 years of age\n2. Patients who are male or non-pregnant female (females of child bearing potential must have a negative pregnancy test prior to enrollment into the study)\n3. Patient is able and willing to sign an Institutional Review Board (IRB) approved Informed Consent Form\n4. Patient has a complex, juxtarenal, pararenal or thoracoabdominal abdominal aortic aneurysm (Extent I-V) that meets at least one of the following:\n\n   * Aortic aneurysm with diameter ≥ 5.5cm\n   * Aortic aneurysm with a history of growth ≥0.5cm in the last 6 months\n   * Symptomatic aortic aneurysm\n5. Cannot be treated with a currently available non-modified approved device\n6. High risk for open surgical repair based on any of the factors below:\n\n   1. Anatomic i. Previous abdominal surgery ii. Previous left-sided thoracotomy (if the proposed open repair would require dissection of the thoracic aorta) iii. Previous aortic surgery\n   2. Physiologic i. ASA Category III or higher ii. Age \\>70 years iii. Previous myocardial infarction, coronary artery disease, or coronary artery stent iv. Coronary stress test with a reversible perfusion defect v. Congestive heart failure vi. COPD\n7. Patient has patent iliac or femoral arteries that will allow endovascular access with the physician modified endovascular graft or is suitable for an iliac conduit\n8. Patient has a suitable non-aneurysmal proximal aortic neck length (seal zone) of ≥ 20 mm\n9. Patient has a suitable non-aneurysmal distal iliac artery length (seal zone) of ≥ 15 mm.\n10. The resultant repair should preserve patency in at least one hypogastric artery.\n11. Patient has a suitable non-aneurysmal proximal aortic neck diameter between 15 and 42mm\n12. Patient has suitable non-aneurysmal distal common iliac diameters between 7 and 20 mm.\n\n---Exclusion Criteria---\n\n-General Exclusion Criteria-\n\n1. Patient has a mycotic aneurysm\n2. Patient has a ruptured aneurysm requiring urgent or emergent repair\n3. Patient has a systemic or local infection that may increase the risk of graft infection\n4. Patient has a body habitus that would inhibit X-ray visualization of the aorta.\n5. Patient is willing and eligible to participate in a manufacturer-sponsored clinical study at another institution\n6. Patient has a major surgical or interventional procedure planned within +\u002F- 30 days of the (T)AAA repair.\n7. Patient is currently participating in another investigational device or drug clinical trial.\n\n-Medical Exclusion Criteria-\n\n1. Patient has a known hypersensitivity or contraindication to anticoagulation or contrast media that is not amenable to pre-treatment.\n2. Patient has a known allergy or intolerance to stainless steel, polyester, polypropylene, nickel, titanium or gold.\n3. Patient has uncorrectable coagulopathy\n4. 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)\n5. Patient has history of connective tissue disease (e.g., Marfan's or Ehler's-Danlos syndrome).\n6. Patient has active malignancy with life expectancy of less than 2 years\n7. Patient has a limited life expectancy of less than 2 years.\n8. 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.\n\n-Anatomic Exclusion Criteria-\n\n1. Significant occlusive disease, tortuosity or calcification that would prevent endovascular access\n2. Proximal seal site with a circumferential thrombus\u002Fatheroma\n3. Inability to maintain at least one patent hypogastric artery\n4. Shaggy aorta\n5. Patient is not amenable to a temporary or permanent open surgical or endovascular conduit","18 Years",{"count":48,"type":19},40,"INTERVENTIONAL",[51],"NA","The physician modified endograft is intended for treating complex, pararenal, juxtarenal and thoracoabdominal aortic aneurysms requiring coverage of renal arteries, the superior mesenteric artery or the celiac trunk in high-risk patients who do not have an option for endovascular repair with an FDA approved endograft and have an appropriate anatomy. There will be one investigational site with a total of 40 subjects to be enrolled. Time to complete enrollment will be 24 months and the subject follow-up time will be five years from last subject enrollment.\n\nThe primary safety endpoint is freedom from major adverse events (MAE) at 30 days or during hospitalization if this exceeds 30 days. The primary effectiveness endpoint is the proportion of study subjects with treatment success at one year. The subjects will be followed at one month, six months, one year, and yearly thereafter for a total period of five years. Subjects will be followed up clinically for life. Clinical exam follow up may be phone or video visit with CT scan evaluation and duplex ultrasound as needed. The proportion of treatment group subjects that achieve and maintain treatment success annually to five years will be investigated.",[54,55,25,24],"Complex Abdominal Aortic Aneurysm","Juxtarenal Aortic Aneurysm","2026-05-01",{"date":58,"type":30},"2026-05-06",{"date":60,"type":30},"2023-03-01",{"date":62,"type":19},"2029-12",{"name":64,"class":65},"University of California, Davis","OTHER",1,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":49,"phases":76,"briefSummary":77,"conditions":78,"keywords":81,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":66},"100610180","physician-modified-endografts-for-complex-aortic-aneurysms-and-thoracoabdominal-aneurysm-repair-in-high-risk-patients-100610180","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",{"count":75,"type":19},15,[51],"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",[79,80,25],"Abdominal Aortic Aneurysms","Thoracoabdominal Aneurysms",[72,82,83,84],"abdominal aortic aneurysms","thoracoabdominal aneurysms","pararenal aortic aneurysms","2026-01-19",{"date":87,"type":30},"2026-01-21",{"date":89,"type":30},"2025-09-01",{"date":91,"type":19},"2030-09-01",{"name":93,"class":65},"Steven Maximus",{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":49,"phases":103,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":115},"100454312","pmeg-for-repair-of-pararenal-and-thoracoabdominal-aortic-aneurysm-100454312","NCT05195905","PMEG for Repair of Pararenal and Thoracoabdominal Aortic Aneurysm","Evaluation of Spinal Cord Ischemia and Mortality and Morbidity After Endovascular Repair of Pararenal and Thoracoabdominal Aortic Aneurysm Using Surgeon-Modified Endografts","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Male or female, aged ≥18 years\n3. Expected survival beyond 1 year following successful aneurysm repair\n4. Anatomy that would require coverage of the celiac artery, superior mesenteric artery (SMA), and\u002For renal arteries if conventional, FDA-approved endograft were implanted to obtain adequate sealing zone length\n5. Aneurysm of the thoracoabdominal or pararenal aorta with or without chronic dissection\n6. Adequate proximal zone of fixation\n7. Adequate distal zone of fixation\n8. No more than 5 non-aneurysmal visceral (celiac, SMA, or renal) arteries with diameters between 4-12mm\n9. Adequate arterial access for delivery system; use of iliac conduit is permitted as necessary\n\nExclusion Criteria:\n\n1. Moderate-to-severe aortic neck calcification, thrombus, or tortuosity\n2. Severe iliac stenosis, calcification, or tortuosity with no ability to perform a conduit\n3. Proximal landing within zone 0 or 1\n4. Inability to maintain at least one patent hypogastric artery\n5. Freely ruptured aneurysm with hemodynamic instability\n6. Non-ambulatory status\n7. Severe CHF\n8. Baseline eGFR \\\u003C 30ml\u002Fmin, unless currently on or to be initiating dialysis\n9. Unstable angina\n10. Stroke or MI within 3 months of planned treatment date\n11. Active systemic infection and\u002For mycotic aneurysm\n12. Uncorrectable coagulopathy or other bleeding diathesis\n13. Known allergy to device material or contrast material that cannot be adequately pre-medicated\n14. Body habitus that would preclude adequate fluoroscopic visualization of aorta\n15. Pregnancy or lactation (confirmed per standard of care surgical practice)\n16. Major, unrelated surgical procedure planned ≤30 days from endovascular repair\n17. Patient is ≤30 days beyond primary endpoint for another investigative clinical drug\u002Fdevice trial\n18. Social or psychological issues that would interfere with ability to comply with all study procedures for the duration of the study\n19. Can be treated in accordance with the instructions for use with a legally marketed endovascular device, including a manufacturer-fabricated custom device\n20. Can enroll in a manufacturer-sponsored clinical study at our institution or is willing and eligible to participate in a study with a manufacturer-made device at another institution",{"count":102,"type":19},30,[51],"The primary objective is to evaluate the safety and effectiveness of surgeon modified endografts for the treatment of pararenal and thoracoabdominal aortic pathology in patients who are not candidate for traditional open repair due to comorbid issues and their anatomy is not amenable to commercially available endografts.",[25,24],"2025-04-14",{"date":108,"type":30},"2025-04-16",{"date":110,"type":30},"2023-06-06",{"date":112,"type":19},"2029-08",{"name":114,"class":65},"Konstantinos Dean Arnaoutakis, MD",2]