[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pararenal-aneurysm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pararenal-aneurysm":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,48,72,95],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100429696","zenith-fenestrated-clinical-study-100429696",false,"NCT04875429","Zenith® Fenestrated+ Clinical Study","Zenith® Fenestrated+ Endovascular Graft Clinical Study","Include Criteria:\n\n1. Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with a diameter ≥ 55 mm for males and ≥ 50 mm for females\n2. Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with a growth rate of ≥ 5 mm in 6 months\n3. Thoracoabdominal, pararenal or juxtarenal aortic aneurysm with aortic diameter \\> 2x the normal aortic diameter or saccular aneurysm that warrants treatment in the opinion of the investigator\n\nExclusion Criteria:\n\n1. Age \\\u003C 18 years\n2. Life expectancy \\\u003C 2 years\n3. Pregnant, breast-feeding, or planning to become pregnant within 60 months\n4. Inability or refusal to give informed consent by the patient or legally authorized representative\n5. Unwilling or unable to comply with the follow-up schedule, required clinical assessments, and imaging\n6. Simultaneous participation in another investigation study, unless the patient is at least 30 days beyond the primary endpoint of any previous study","ALL","18 Years",{"count":19,"type":20},105,"ESTIMATED","INTERVENTIONAL",[23],"NA","The Zenith® Fenestrated+ Endovascular Graft Clinical Study will assess the safety and effectiveness of the Zenith® Fenestrated+ Endovascular Graft (ZFEN+) in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System (BeGraft) and Unibody2 for the treatment of patients with aortic aneurysms involving one or more of the major visceral arteries.\n\nUp to 60 additional subjects may be enrolled in Continued Access phase of the study",[26,27,28,29],"Aortic Aneurysm, Abdominal","Juxtarenal Aortic Aneurysm","Extent IV Thoracoabdominal","Pararenal Aneurysm",[31,32,33,34],"endovascular","Vascular Diseases","Cardiovascular Diseases","Fenestration","RECRUITING","2026-03-19",{"date":38,"type":39},"2026-03-23","ACTUAL",{"date":41,"type":39},"2023-12-08",{"date":43,"type":20},"2031-11",{"name":45,"class":46},"Cook Research Incorporated","INDUSTRY",33,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":71},"100556559","clinical-outcomes-and-major-adverse-events-in-patients-treated-with-physician-modified-fenestrated-and-branched-stent-grafts-100556559","NCT06526676","Clinical Outcomes and Major Adverse Events in Patients Treated With Physician-Modified Fenestrated and Branched Stent Grafts","Clinical Outcomes and Predictors of Major Adverse Events in Patients Treated for Juxtarenal, Pararenal and Thoracoabdominal Aortic Aneurysms With Physician-Modified Fenestrated and Branched Stent Grafts","Inclusion Criteria:\n\nA patient may be included in the study if at least one of the following is present and is considered appropriate for treatment with a physician modified stent graft. Patients must be deemed high risk for traditional open surgical repair, if any of the following conditions are present.\n\nPatients will be deemed physiologically high risk if any of the following conditions are present:\n\n* Older than 75 years of age\n* Chronic obstructive pulmonary disease\n* Congestive heart failure\n* Previous myocardial infarction, coronary stent, or bypass\n* Chronic renal insufficiency with baseline eGFR \\\u003C 40 ml\u002Fmin\n* American Society of Anesthesiologist (ASA) score \\> 3\n\nPatient will be deemed anatomically high risk if any of the following conditions are present:\n\n* Prior intraabdominal operation(s)\n* Prior abdominal wall reconstructions. (ie. Ventral hernia repairs)\n* Prior radiation therapy targeting abdomen and\u002For pelvis\n* History of intraabdominal sepsis. (ie. Diverticulitis managed with percutaneous drainage)\n\nPatients will then be included in one of three arms with the inclusion criteria specified as follows:\n\n* Arm 1 (Short neck infrarenal, juxtarenal, suprarenal and extent IV TAA)\n\n  * Juxtarenal, pararenal, suprarenal or extent IV thoracoabdominal aortic aneurysm or dissection with a diameter ≥ 5.5 cm or 2 times the normal aortic diameter.\n  * Juxtarenal, pararenal, suprarenal or extent IV thoracoabdominal aneurysm with a history of growth ≥ 0.5 cm in one year.\n  * Juxtarenal, pararenal, suprarenal or extent IV thoracoabdominal saccular aneurysms deemed at significant risk for rupture based upon physician interpretation.\n  * Presence of juxtarenal, pararenal, suprarenal or extent IV thoracoabdominal aortic aneurysm not meeting one of the above-mentioned criteria with or without unilateral or bilateral common iliac artery aneurysm with diameter ≥ 3.5-cm or saccular morphology with no suitable landing zone proximal to iliac bifurcation.\n* Arm 2 (Thoracoabdominal aortic aneurysms)\n\n  * Extent I, II, or III thoracoabdominal aortic aneurysm or dissection with a diameter ≥ 5.5 cm or 2 times the normal aortic diameter.\n  * Extent I, II, or III thoracoabdominal aortic aneurysm with a history of growth ≥ 0.5 cm in one year.\n  * Extent I, II, or III thoracoabdominal saccular aortic aneurysms deemed at significant risk for rupture based upon physician interpretation.\n  * Presence of Extent I, II, or III thoracoabdominal aortic aneurysm not meeting one of the above-mentioned criteria with or without unilateral or bilateral common iliac artery aneurysm with diameter ≥ 3.5-cm or saccular morphology with no suitable landing zone proximal to iliac bifurcation.\n* Arm 3 (Urgent or emergent aneurysms) o Ruptured, contained ruptured or symptomatic juxtarenal, pararenal, suprarenal or thoracoabdominal aortic aneurysm planned to receive urgent or emergent repair within 48 hours of clinical encounter, in patients able to provide informed consent and deemed not a reasonable candidate for open surgery or repair with any commercially available device.\n\nExclusion Criteria:\n\nPatients must be excluded from the study if any of the following conditions are true:\n\n* Less than 18 years of age\n* Unwilling to comply with the follow-up schedule\n* Inability or refusal to give informed consent by the patient or a legally authorized representative\n* Pregnant or breastfeeding\n* Life expectancy \\\u003C 2-years\n* Prior open surgical or interventional procedure within 30 days of the anticipated date of the fenestrated-branched procedure, with the exception of planned staged procedures to provide access for repair (e.g. staged iliac conduit, cervical debranching, elephant trunk repair), to facilitate the procedure by allowing open revascularization of a target artery not amenable to revascularization with the investigational device, such as an internal iliac artery, subclavian artery or visceral artery with early bifurcation, tortuosity or occlusive disease preventing successful placement of alignment side stents.\n* Patients eligible for treatment with any FDA-approved marketed device within its instructions for use\n* Can enroll in a manufacturer-sponsored clinical study at our institution or is willing and eligible to participate in a study with a manufactured-made device at another institution\n* Participation in another investigational clinical or device trial, with the exception of participation in another investigational endovascular stent-graft protocol, percutaneous aortic valve protocol, or concomitant clinical trials designed to evaluate medical therapy strategies to reduce perioperative risk during fenestrated-branched endovascular repair, including risks of renal dysfunction, contrast-induced nephropathy, neurologic, spinal cord or cardiac complications, and\u002For use of advanced imaging to reduce radiation exposure during implantation of these devices. Participation in investigational device trials not encompassed by the IDE protocol should be performed remotely from the fenestrated procedure (\\>30 days). Examples include remote (\\>30 days) participation in a thoracic, abdominal, or iliac branch device trial, or participation in a percutaneous aortic valve trial. Participation in medical therapy trial or advanced imaging trial designed to improve peri-operative outcomes or to reduce radiation exposure of fenestrated-branched endografts may be concurrent with the IDE study. Examples include therapy directed to reduce rates of spinal cord injury, stroke and contrast-induced nephropathy associated with implantation of fenestrated-branched stent-grafts or advanced imaging trials designed to reduce radiation exposure during repair.\n\nMedical Exclusion Criteria:\n\n* Known sensitivities or allergies to stainless steel, nitinol, polyester, solder (tin, silver), polypropylene, PTFE, urethane, or gold.\n* History of anaphylactic reaction to contrast material that cannot be adequately pre-medicated.\n* Uncorrectable coagulopathy.\n* Mycotic aneurysm or patients with evidence of active systemic infection.\n* History of connective tissue disorder (e.g vascular Ehlers Danlos, Marfan's syndrome), except for those patients who had prior open surgical aortic replacement, where a surgical graft would serve as landing zone for the investigational stent-graft, those who are deemed prohibitive risk for open surgical repair or connective tissue disorders with no effect of vascular system (e.g non-vascular Ehlers Danlos).\n* Body habitus that would inhibit X-ray visualization of the aorta and its branches.\n\nAnatomic Exclusion Criteria\n\n* Inadequate femoral or iliac access compatible with the required delivery systems.\n* Inability to perform a temporary or permanent open surgical or endovascular iliac conduit for patients with inadequate femoral\u002Filiac access.\n* Absence of a non-aneurysmal aortic segment in the distal thoracic aorta above the diaphragmatic hiatus with:\n\n  * A diameter measured outer wall to outer wall of no greater than 42mm and no less than 21 mm;\n  * Parallel aortic wall with \\\u003C20% diameter change and without significant calcification and\u002For thrombus in the selected area of seal zone\n* Visceral vessel anatomy not compatible with fenestrated\u002Fbranched stent graft visceral vessel incorporation due to excessive occlusive disease or small size not amenable to stent graft placement\n* Unsuitable distal iliac artery fixation site and anatomy for iliac limb extension or iliac branch device as per devices' instructions for use (IFU)",{"count":56,"type":20},50,[23],"The purpose of this study is to evaluate safety and effectiveness of endovascular treatment of juxtarenal, pararenal and thoracoabdominal aortic aneurysms (with or without iliac artery involvement) using physician-modified stent grafts with a combination of fenestrations and\u002For branches.",[27,29,60],"Thoracoabdominal Aortic Aneurysm","2025-12-09",{"date":63,"type":39},"2025-12-15",{"date":65,"type":39},"2025-12-02",{"date":67,"type":20},"2032-12",{"name":69,"class":70},"University of California, Los Angeles","OTHER",1,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":71},"100402744","frailty-and-physician-modified-fenestrated-endograft-for-thoracoabdominal-aortic-pathologies-100402744","NCT04524247","Frailty and Physician Modified Fenestrated Endograft for Thoracoabdominal Aortic Pathologies","Impact of Frailty on Clinical Outcomes of Patients Treated for Thoracoabdominal and Complex Abdominal Aortic Aneurysms With Physician-Modified Fenestrated and Branched Stent Grafts","Inclusion Criteria:\n\n* Patients may be included in the study if the patient has at least one of the following indications and are anatomically appropriate for treatment with fenestrated\u002Fbranched stent grafts.\n\n  1. Pararenal, paravisceral, and type I to IV thoracoabdominal aortic aneurysms or chronic post-dissection aneurysms with a diameter 5cm or 2 times the normal aortic diameter.\n  2. Aneurysm with a history of growth ≥ 0.5cm per year.\n  3. Saccular aneurysms deemed at significant risk for rupture based on physician interpretation.\n  4. Symptomatic aneurysm without hemodynamic instability\n  5. Aneurysms meeting any of the above criteria 1\\~4, 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\nExclusion Criteria:\n\n* Patients must be excluded from the study if any of the following conditions is true:\n\n  1. Less than 18 years of age.\n  2. Unwilling to comply with the follow-up schedule.\n  3. Inability or refusal to give informed consent by the patient or a legally authorized representative.\n  4. Pregnant or breastfeeding.\n  5. Life-expectancy less than 2 years.\n  6. Participation in another investigational clinical or device trial, with the exception of participation in another investigational endovascular stent-graft protocol and performed remotely from the fenestrated procedure (\\>30 days). Examples include remote (\\>30days) participation in a thoracic, or abdominal branch device trial.\n  7. Eligible for treatment with FDA-approved marketed device.\n  8. Eligible and willing to travel to a center with IDE protocol wherein the device is made by a manufacturer.",{"count":80,"type":20},100,[23],"The primary objective of this single arm, prospective feasibility study, Impact of Frailty on Clinical Outcomes of Patients Treated for Thoracoabdominal and Complex Abdominal Aortic Aneurysms with Physician-Modified Fenestrated and Branched Stent Grafts, is to assess the use of the physician-modified fenestrated\u002Fbranched endografts to repair thoracoabdominal and complex aortic aneurysms in subjects having appropriate anatomy, at high risks for open repairs. The primary intent of the study is to assess safety and preliminary effectiveness of the device acutely (i.e., treatment success and technical success), at 30 days (i.e., the rate of major adverse events (MAE)) and at 3 months, 6 months, 12 months, and annually to 5 years (i.e., the proportion of treatment group subjects that achieve and maintain treatment success).\n\nAdditionally, this study will assess the degree of patient frailty before and after the aneurysm repair, as well as the association between the preoperative baseline frailty and clinical outcomes detailed above. This will help improve subject selection in identification of high risk patients who would not only suffer poor clinical outcomes, but also experience decline in their functional status.",[60,84,29,85],"Thoracoabdominal; Aortic, Aneurysm, Dissecting","Frailty Syndrome","2024-06-28",{"date":88,"type":39},"2024-07-01",{"date":90,"type":39},"2021-02-23",{"date":92,"type":20},"2032-07-02",{"name":94,"class":70},"University of Southern California",{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":21,"phases":105,"briefSummary":106,"conditions":107,"keywords":111,"overallStatus":113,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":71},"100480061","safety-and-effectiveness-of-surgeon-modified-stent-grafts-fortreatment-of-complex-aortic-aneurysms-100480061","NCT05531084","Safety and Effectiveness of Surgeon-Modified Stent Grafts forTreatment of Complex Aortic Aneurysms","Safety and Effectiveness of Surgeon-Modified Fenestrated and Branched Endografts in Treating Subjects With Complex Aortic Aneurysms","Assets","Inclusion Criteria:\n\n* Age: ≥ 18 years old\n* The subject has one or more of the following:\n\n  1\\. An aneurysm with a maximum diameter of \\> 5.5 cm (in men) and 5 cm (in women) or 2 times the normal diameter just proximal to the aneurysm using orthogonal (i.e, perpendicular to the centerline) measurements 2. Aneurysm with a history of growth \\> 0.5 cm in 6 months or clinically indicated for repair based on symptoms 3. Symptomatic aneurysm 4. Ruptured aneurysm 6. Failed previous EVAR defined as type IA endoleak or increase in aneurysm sac size in the setting of proximal seal loss 7. Saccular aneurysm deemed by the treating vascular specialist at significant risk for rupture 8. High risk for open surgical repair based on any of the factors below:\n\n  a. 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 b. Physiological high risk For this IDE, physiological risk will be assessed using two systems. First, this study will use the Society for Vascular Surgery (SVS)\u002FAmerican Association for Vascular Surgery (AAVS) medical comorbidity grading system recommended for use by the SVS to describe the severity of medical comorbidities in patients with complex aortic aneurysm disease. However, as the current SVS\u002FAAVS grading system has yet to be validated in prospective studies or in a large cohort of patients treated for aortic disease, the American Association of Anesthesiologists grading system will also be utilized due to its widely adopted use and simplicity although it relies on subjective parameters and lacks specific metrics that affect outcomes.\n* American Association of Anesthesiologists grading system: subjects with ASA scores of 3-5 will be considered for study inclusion though final subject approval will be at the discretion of the treating vascular specialist; subjects with ASA scores of 6 will be excluded.\n* SVS\u002FAAVS grading system: high risk (8-20% mortality risk) subjects will be considered for study inclusion though final subject approval will be at the discretion of the treating vascular specialist; prohibitive high risk (31-70% mortality risk) subjects will be excluded.\n\nMedical Inclusion Criteria\n\n* American Association of Anesthesiologists (ASA) physical status classification system: subjects with ASA scores of 1-5 will be considered for study inclusion though final subject approval will be at the discretion of the treating vascular specialist; subjects with ASA scores of 6 will be excluded.\n\nSVS\u002FAAVS grading system: low risk (0.12-1% mortality risk), medium risk (1.7-4.9% mortality risk), and high risk (8-20% mortality risk) subjects will be considered for study inclusion though final subject approval will be at the discretion of the treating vascular specialist; prohibitive high risk (31-70% mortality risk) subjects will be excluded.\n\nAnatomical Inclusion Criteria\n\n* Iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices, or accessories, with or without use of a surgical conduit\n* Extent of aorta to be treated: infrarenal aortic aneurysms with \\\u003C 10 mm neck length, juxtarenal or pararenal aneurysms that include 1 or 2 renal arteries; paravisceral and extent IV-V thoracoabdominal aneurysms, Extent I-III thoracoabdominal aneurysm including those patients requiring a carotid-left subclavian bypass in order to achieve, at least, 20 mm of proximal landing zone\n* Non-aneurysmal aortic segment proximal to the aneurysm (neck) with a:\n\n  1. Minimum neck length of 20 mm\n  2. Diameter in the range of 20 mm - 38 mm\n  3. Angle less than 60 degrees relative to the axis of the aneurysm\n  4. Angle less than 60 degrees relative to the axis of the suprarenal aorta\n* Minimum branch vessel diameter of 5 mm or greater Iliac artery distal fixation site greater than 45 mm in length and diameter in the range of 8 mm to 17 mm\n\nExclusion Criteria:\n\n* Age: \\\u003C 18 years old\n* Does not meet the above inclusion criteria\n* Can be treated in accordance with the instructions for use with a commercially approved and marketed endovascular prosthesis\n* Is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site with the exception of percutaneous aortic valve surgery\n* Unwilling or unable to comply with the follow-up schedule\n* Inability or unwillingness of patient or patient's legally authorized representative to provide informed consent.\n* Subject is pregnant or breastfeeding\n* Any other circumstance or condition which, at the discretion of the sponsor-investigator, makes the patient unsuitable for inclusion Medical Exclusion Criteria\n* Known sensitivities or allergies to the materials of construction of the devices, including but not limited to titanium and PTFE.\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* 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* Unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest, or nocturnal angina)\n* Systemic or local infection that may increase the risk of endovascular graft infection\n* Baseline creatinine greater than 2.0 mg\u002FdL\n* History of connective tissue disorders (e.g., Marfan Syndrome, Ehler's Danlos Syndrome) with the exception of patients who have had prior open surgical aortic replacement where a surgical graft would serve as a \"landing zone\" for the investigational stent-graft Anatomical Exclusion Criteria\n\n  1. Significant occlusive disease, tortuosity, or calcification that would prevent endovascular access\n  2. Proximal neck length ≤20 mm\n  3. Proximal neck, measured outer wall to outer wall on a sectional image (CT)\n\n     1. For use of Zenith Fenestrated: diameter \\>32 mm or \\\u003C18 mm\n     2. For use of Zenith Alpha Thoracic: diameter \\>38 mm or \\\u003C18 mm (for proximal and distal neck diameter)\n     3. Zenith TX2 Dissection Endovascular graft: diameter 38 mm or \\\u003C18 mm\n     4. Zenith Flex AAA endovascular graft: diameter \\>32 mm or \\\u003C 18 mm\n  4. Proximal neck angulated more than 60 degrees relative to the long axis of the aneurysm\n  5. Proximal neck diameter changes over the length of the proximal seal zone \\>4 mm\n  6. Proximal seal site with a circumferential thrombus\u002Fatheroma\n  7. Iliac artery diameter, measured inner wall to inner wall on a sectional image (CT) \\\u003C7.0 mm at any point along access length (prior to deployment)\n  8. Ipsilateral iliac artery fixation site diameter, measured inner wall on a sectional image (CT) \\>21 mm at distal fixation site\n  9. Iliac artery distal fixation site \\\u003C10 mm in length\n  10. Non-bifurcated segment of any artery to be stented \\\u003C 15 mm in length\n  11. Artery to be stented with a maximum diameter \\\u003C3 mm or \\>10 mm at the vessel ostium\n  12. Inability to maintain at least one patent hypogastric artery\n  13. Bilateral renal artery stenosis \\>80%\n  14. Superior mesenteric artery stenosis \\>80%",{"count":104,"type":20},25,[23],"The primary objective of the present study is to evaluate the safety, effectiveness, and clinical outcomes of surgeon-modified fenestrated stent grafts used to treat patients with failed previous infrarenal repairs (failed EVAR) and complex aortic aneurysms (thoracoabdominal, juxtarenal, pararenal, and paravisceral aneurysms).",[108,27,29,109,110],"Thoracoabdominal Aneurysm","Aortic Aneurysm","Failed Previous Infrarenal Repairs (Failed EVAR)",[112],"surgeon-modified fenestrated stent grafts","NOT_YET_RECRUITING","2022-10-03",{"date":116,"type":39},"2022-10-06",{"date":118,"type":20},"2022-10-01",{"date":120,"type":20},"2032-10-01",{"name":122,"class":70},"Jesse Manunga, MD"]