[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"juxtarenal-aortic-aneurysm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:juxtarenal-aortic-aneurysm":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,42,66,97,141,162],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100566639","physician-modified-endovascular-grafts-for-the-treatment-of-juxtarenal-aortic-aneurysms-100566639",false,"NCT06657794","Physician Modified Endovascular Grafts for the Treatment of Juxtarenal Aortic Aneurysms","Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Juxtarenal Aortic Aneurysms","PMEG","Inclusion Criteria:\n\nAll patients must meet all of the following inclusion criteria to be eligible for enrollment into the 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:\n\n   1. An aneurysm with a maximum diameter of ≥ 5.5 cm for male (≥ 5.0 cm for female) or 2 times the normal diameter just proximal to the aneurysm using orthogonal (i.e., perpendicular to the centerline) measurements\n   2. Aneurysm with a history of growth \\> 0.5 cm in 6 months\n   3. Saccular aneurysm deemed at significant risk for rupture\n   4. Symptomatic aneurysm\n   5. Ruptured aneurysm\n5. Patient has patent iliac or femoral arteries, with or without the use of conduit, that will allow endovascular access with the physician modified endovascular graft.\n6. Patient has a suitable non-aneurysmal proximal aortic neck of ≥ 2 mm inferior to the most distal renal artery ostium.\n7. Patient has a suitable non-aneurysmal distal iliac artery length (seal zone) of ≥ 15mm. The resultant repair should preserve patency in at least one hypogastric artery.\n8. Patient has a suitable non-aneurysmal proximal aortic neck diameter between 20 and 32 mm, averaged across the diameters at the Celiac, SMA, at the lowest patent renal artery and at the midpoint of the renal arteries.\n9. Patient has suitable non-aneurysmal distal common iliac diameters between 8 and 20 mm.\n10. Patient has juxtarenal aortic neck angulation ≤ 60°\n11. Target branch vessel diameter ≥ 5 mm.\n12. Patient must be willing to comply with all required follow-up exams.\n\nExclusion Criteria:\n\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 or local infection that may increase the risk of endovascular infection\n2. Patient has unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina, or onset of prolonged angina)\n3. Patient has a major surgical or interventional procedure, not related to the endovascular repair, planned within +\u002F- 30 days of the AAA repair.\n4. Patient has history of an aortopathic connective tissue disease (e.g. Marfan's or Ehler's-Danlos syndrome).\n5. Patient has a known hypersensitivity or contraindication to anticoagulation or contrast media that is not amenable to pre-treatment.\n6. Patient has known allergy or intolerance to stainless steel, nitinol or gold (gold-coated tungsten).\n7. Patient has a body habitus that would inhibit X-ray visualization of the aorta\n8. Patient has a limited life expectancy of less than 1 year\n9. Patient is currently participating in another investigational device or drug clinical trial\n10. Patient has other medical, social or psychological conditions that, in the opinion of the investigator, preclude them from receiving the pretreatment, required treatment, and post-treatment procedures and evaluations.\n11. Thrombus or excessive calcification within the neck of the aneurysm\n12. Branch vessel stenosis ≥ 80%\n13. Patient treatable on label with FDA approved EVAR or FEVAR device and can wait for device availability.\n14. Subject is willing and eligible to enroll in a manufacturer-sponsored study at the investigational site, or the subject is willing and eligible to participate in a study with a manufacturer-made device at another institution.","ALL","18 Years",{"count":20,"type":21},15,"ESTIMATED","INTERVENTIONAL",[24],"NA","The primary objective of the clinical investigation \"Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Juxtarenal Aortic Aneurysms\" is to assess the use of the Physician-Modified Endovascular Grafts to repair juxtarenal aneurysms in high-risk subjects considered to be unsuitable candidates for open surgical repair, have limited or no other options for treatment, and having appropriate anatomy. The primary intent of the study is to assess safety and preliminary effectiveness of the device:\n\n* acutely (i.e., treatment success and technical success);\n* at 30 days (i.e., the rate of major adverse events (MAE)); and\n* at 6 months, 12 months and annually to 5 years (i.e., the proportion of treatment group subjects that achieve and maintain treatment success).",[27,28],"Juxtarenal Aortic Aneurysm","Aortic Rupture","RECRUITING","2026-06-24",{"date":32,"type":33},"2026-06-29","ACTUAL",{"date":35,"type":33},"2025-02-17",{"date":37,"type":21},"2030-12-31",{"name":39,"class":40},"The Cleveland Clinic","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":41},"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",{"count":50,"type":21},40,[24],"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.",[54,27,55,56],"Complex Abdominal Aortic Aneurysm","Pararenal Aortic Aneurysm","Thoracoabdominal Aortic Aneurysm","2026-05-01",{"date":59,"type":33},"2026-05-06",{"date":61,"type":33},"2023-03-01",{"date":63,"type":21},"2029-12",{"name":65,"class":40},"University of California, Davis",{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":22,"phases":75,"briefSummary":76,"conditions":77,"keywords":81,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":96},"100429696","zenith-fenestrated-clinical-study-100429696","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",{"count":74,"type":21},105,[24],"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",[78,27,79,80],"Aortic Aneurysm, Abdominal","Extent IV Thoracoabdominal","Pararenal Aneurysm",[82,83,84,85],"endovascular","Vascular Diseases","Cardiovascular Diseases","Fenestration","2026-03-19",{"date":88,"type":33},"2026-03-23",{"date":90,"type":33},"2023-12-08",{"date":92,"type":21},"2031-11",{"name":94,"class":95},"Cook Research Incorporated","INDUSTRY",33,{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":22,"phases":106,"briefSummary":107,"conditions":108,"keywords":113,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":41},"100212530","evaluation-of-the-cook-custom-aortic-endograft-the-zenith-t-branch-endovascular-graft-and-surgeon-modified-endograft-in-treating-aortic-pathologies-100212530","NCT02043691","Evaluation of the Cook Custom Aortic Endograft, the Zenith t-Branch Endovascular Graft, and Surgeon-Modified Endograft in Treating Aortic Pathologies","Evaluation of All-Cause Mortality and Pulmonary Morbidity in Treating Juxtarenal, Suprarenal, Thoracoabdominal, and Aortic Arch Pathologies Using Cook Custom Aortic Endografts, the Zenith t-Branch Endovascular Graft, and the Surgeon-Modified Endograft","Inclusion Criteria:\n\n* Juxtarenal, suprarenal, and thoracoabdominal aortic pathology as follows in hemodynamically stable patients:\n\n  1. Intact or contained ruptured aortic or aortoiliac aneurysms (atherosclerotic\u002Fdegenerative or saccular) involving or in close approximation to the visceral segment of the aorta.\n\n     1. Diameter \\> 5.5 cm if asymptomatic, or 5.0 cm with enlargement of \\> 0.5 cm in 6 months.\n     2. History of growth \\> 0.5 cm per year\n     3. Any size if ruptured or symptomatic\n  2. Penetrating aortic ulcer (PAU)\n\n     1. \\> 2.0 cm in depth\n     2. Any size if contained ruptured or symptomatic\n  3. Subacute (\\>14 days) or chronic (\\>20 days) aortic dissection with aneurysmal degeneration with at least one of the following:\n\n     1. Total aortic diameter \\> 5.5 cm if asymptomatic\n     2. Total aortic diameter \\> 4.5 cm if symptomatic\n     3. Total aortic diameter \\> 5.0 cm and history of growth \\> 0.5 cm in 6 months\n* Aortic Arch pathology:\n\n  1. Aneurysm, Ascending thoracic aortic pseudoaneurysm, Type A thoracic aortic dissection, Retrograde type A thoracic aortic dissection between the Sinus of Valsalva and the innominate artery orifice (without involvement of the Aortic Valve), or Ascending penetrating aortic ulcer with and without intramural hematoma\n  2. Suitable iliac artery and brachial artery access\n  3. Absence of severe landing zone (\\> 90 degree) angulation that would preclude necessary device delivery\u002Fseal\u002Ffixation.\n  4. Suitable iliac artery access to accommodate device delivery system.\n  5. Target arteries for arch branches:\n\n     1. \\\u003C 24 mm diameter\n     2. Adequate landing zone length to obtain proximal and distal seal.\n     3. Free from dissection precluding adequate seal in distal landing zone of branch stent and severe tortuosity\u002Fthrombus\u002Fcalcification.\n* Aortic Arch Aneurysm\n\n  1. Proximal aortic fixation zone:\n\n     1. Native aorta or surgical graft\n     2. Diameter: 20 - 42 mm\n  2. Proximal neck length \\> 20 mm\n  3. Must occur distal to coronary arteries and any coronary artery bypass grafts that are considered patent and necessary for proper cardiac perfusion.\n  4. Distal aortic fixation zone:\n\n     1. Native aorta or surgical graft\n     2. Diameter: 20 - 44 mm\n  5. Distal neck length \\> 20 mm. However, if dissection, distal graft may land in dissected aorta.\n  6. Supra-aortic trunk (brachiocephalic) vessels (Any combination of arteries may be used for repair) A. Innominate artery\n\n     1. Native vessel or surgical graft\n     2. Diameter: 8 - 22 mm\n     3. Length of sealing zone \\> 10 mm\n     4. Acceptable tortuosity B. Left (or right) common carotid artery\n\n     \u003C!-- -->\n\n     1. Native vessel or surgical graft\n     2. Diameter 5 - 20 mm\n     3. Length of sealing zone \\> 10 mm C. Left (or right) subclavian artery\n\n     \u003C!-- -->\n\n     1. Native vessel or surgical graft\n     2. Diameter 5 - 20 mm\n     3. Length of sealing zone \\> 10 mm\n* Aortic Dissection\n\n  1. Access into the true lumen from the groin and at least one supra-aortic trunk vessel.\n  2. Seal zone in the target aorta (or surgical graft) that is proximal to the primary dissection, such that a stent-graft would be anticipated to seal off the dissection lumen.\n  3. Seal zone in the target supra-aortic trunk vessels that is distal to the dissection, anticipated to seal off the dissection lumen or surgically created.\n  4. True lumen size large enough to deploy the device and still gain access into the target branch.\n\nGeneral Exclusion Criteria:\n\n* Less than 18 years of age\n* Life expectancy less than 12 months based on the surgeon's assessment\n* Pregnant or breastfeeding or planning on becoming pregnant within 60 months\n* Inability or refusal to give informed consent\n* Unwilling or unable to comply with the follow-up schedule\n* Less than 30 days beyond primary endpoint for other investigative drug or device study\n\nMedical Exclusion Criteria:\n\n* Known allergy to the device components (i.e. stainless steel, polyester, solder, gold, or nitinol)\n* History of anaphylactic reaction to contrast material that cannot be adequately premedicated\n* Systemic or local infection that may increase the risk of endovascular graft infection.\n* Baseline eGFR \\\u003C 30 mL\u002Fmin (calculated by the Modification of Diet in Renal Disease formula) and not on hemo- or peritoneal dialysis. If the patient is currently on dialysis, or is currently planning on initiating dialysis, then they may undergo repair.\n* Body habitus that would inhibit X-ray visualization of the aorta.\n* Major surgical or interventional procedure unrelated to the treatment of the aneurysm planned ≤ 30 days of the endovascular repair.\n* Unstable angina, defined as a progressive increase in symptoms, new onset at rest or nocturnal angina, or onset of prolonged angina.\n* Irreversible coagulopathy\n\nAnatomical Exclusion Criteria:\n\n* Aortic transection due to acute trauma.\n* Infectious (\"mycotic\") etiology of the aortic disease.\n* Significant occlusive disease or tortuosity precluding delivery of the device components.\n* Juxtarenal, Suprarenal, and Thoracoabdominal:\n* Proximal Landing zone \\\u003C 20 mm in length. The proximal landing zone can be within zones 2 through 8, with least 20 mm of proximal seal and fixation in aorta or Dacron.\n* Proximal neck, defined as the thoracic aorta distal to the native left carotid artery, measured outer wall to outer wall on a sectional image (CT) \\> 41 mm in diameter or \\\u003C 18 mm in diameter\n* Distal landing zone \\\u003C 20 mm in length if the landing zone is in the aorta, or \\\u003C 20 mm if the landing zone is in the iliac arteries or in Dacron (in the event the patient has had a previous or concomitant aortic or aorto-iliac reconstruction).\n* Untreatable branch vessel stenosis.\n* Anatomy that would not allow maintenance of at least one patent hypogastric artery.\n* Signs that the inferior mesenteric artery (IMA) is indispensable (i.e. angiographic visualization or a large IMA, filling of superior mesenteric artery (SMA) via collaterals, stenosis of celiac or SMA or oblique views) and the indispensable IMA is not amenable to treatment with a graft branch or fenestration.\n* Branching, duplication, aneurysm or untreatable stenosis of the celiac, SMA or renal arteries that would preclude implantation of the investigational devices.\n* Aortic arch:\n* Proximal neck \\> 44 mm or \\\u003C 28 mm in diameter\n* Inadequate landing zone to allow adequate distal seal of exclusion of false lumen perfusion in dissection.\n* Untreatable branch vessel stenosis.\n* Significant occlusive disease, tortuosity, or calcification that would prevent endovascular access.\n* Patients qualifying for an industry-sponsored study allowing for a similar repair will be enrolled in the industry-sponsored study.",{"count":105,"type":21},410,[24],"This is a single-center study to evaluate the safety and effectiveness of three investigational devices, the Cook Custom Aortic Endograft, the Zenith t-Branch Endovascular Graft, and the Surgeon-Modified Endografts in the treatment of Juxtarenal, Suprarenal, Thoracoabdominal, and Aortic Arch pathologies involving the at least one brachiocephalic artery or visceral vessels.\n\nThe three investigational devices offer an endovascular approach to treat complex aortic pathologies that cannot be treated with commercially available devices. This customized, endovascular approach has the potential to decrease hospital length of stay, pulmonary complications, and in-hospital mortality.",[27,109,56,110,111,112],"Suprarenal Aortic Aneurysm","Penetrating Aortic Ulcer","Aortic Arch Aneurysm","Aortic Dissection",[114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131],"Endovascular","Aortic","Aneurysm","Thoracoabdominal","Juxtarenal","Suprarenal","Endograft","Fenestrated","Branched","Complex","Abdominal","Thoracic","Stent","Stentgraft","Arch","Ascending","Dissection","Descending","2026-01-02",{"date":134,"type":33},"2026-01-06",{"date":136,"type":33},"2014-06",{"date":138,"type":21},"2027-10",{"name":140,"class":40},"University of Alabama at Birmingham",{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":148,"targetDuration":4,"studyType":22,"phases":150,"briefSummary":151,"conditions":152,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":41},"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":149,"type":21},50,[24],"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.",[27,80,56],"2025-12-09",{"date":155,"type":33},"2025-12-15",{"date":157,"type":33},"2025-12-02",{"date":159,"type":21},"2032-12",{"name":161,"class":40},"University of California, Los Angeles",{"id":163,"slug":164,"hasResults":11,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":168,"eligibilityCriteria":169,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":170,"targetDuration":4,"studyType":22,"phases":172,"briefSummary":173,"conditions":174,"keywords":178,"overallStatus":180,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":41},"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":171,"type":21},25,[24],"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).",[175,27,80,176,177],"Thoracoabdominal Aneurysm","Aortic Aneurysm","Failed Previous Infrarenal Repairs (Failed EVAR)",[179],"surgeon-modified fenestrated stent grafts","NOT_YET_RECRUITING","2022-10-03",{"date":183,"type":33},"2022-10-06",{"date":185,"type":21},"2022-10-01",{"date":187,"type":21},"2032-10-01",{"name":189,"class":40},"Jesse Manunga, MD"]