[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"complex-abdominal-aortic-aneurysm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:complex-abdominal-aortic-aneurysm":23},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,74],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":27,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100508130","european-aortic-data-collection-project-100508130",false,"NCT05896397","European Aortic Data Collection Project","EADC","Inclusion Criteria:\n\n1\\. Patients who will be treated with a Cook CMD\n\nExclusion Criteria:\n\n1. Patients who declare they are unable to complete clinical follow-up visit at the time of enrollment, or\n2. Patients or his\u002Fher legally authorized representative objects to extraction of patient's data from the medical record, or unwilling to sign the Informed Consent.","ALL",{"count":18,"type":19},600,"ESTIMATED","OBSERVATIONAL","The purpose of this study is to evaluate the safety and performance of Cook's various Custom-Made Stent-graft Devices (CMD) used for endovascular treatment of the aorta and related diseases by collecting information on the real-world use of the devices.\n\nThe study results will be used to support the continuation of the CMDs on the market. In addition, the study will support the manufacturers obligation for post market product surveillance as well as Cook's technology development.",[23,24,25,26],"Complex Abdominal Aortic Aneurysm","Thoracoabdominal Aortic Aneurysm","Aortic Arch Aneurysm","Chronic Aortic Dissection",[28,29,30,31,32],"Complex aortic repair","Aortic aneurysm","Aortic dissection","Fenestrated\u002Fbranched endograft","Custom-made endovascular graft","RECRUITING","2026-06-03",{"date":36,"type":37},"2026-06-04","ACTUAL",{"date":39,"type":37},"2023-05-31",{"date":41,"type":19},"2030-12",{"name":43,"class":44},"Cook Research Incorporated","INDUSTRY",18,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"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":55,"type":19},40,"INTERVENTIONAL",[58],"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.",[23,61,62,24],"Juxtarenal Aortic Aneurysm","Pararenal Aortic Aneurysm","2026-05-01",{"date":65,"type":37},"2026-05-06",{"date":67,"type":37},"2023-03-01",{"date":69,"type":19},"2029-12",{"name":71,"class":72},"University of California, Davis","OTHER",1,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":56,"phases":83,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":5},"100216042","caaas-taaas-aortic-arch-aneurysms-or-dissections-with-fenestratedbranched-stent-graft-100216042","NCT02089607","CAAAs, TAAAs, Aortic Arch Aneurysms or Dissections With Fenestrated\u002FBranched Stent Graft","Clinical Outcomes and Quality of Life Measures in Patients Treated for Complex Abdominal, Thoracoabdominal and Aortic Arch Aneurysms or Dissections With Fenestrated and Branched Stent Grafts","General Inclusion Criteria:\n\n* Thoracoabdominal aortic aneurysm with a diameter ≥ 5.5 cm or 2 times the normal aortic diameter.\n* Aneurysm with a history of growth ≥ 0.5 cm per year.\n* Saccular aneurysms deemed at significant risk for rupture based upon physician interpretation.\n* Presence of concomitant thoracoabdominal and aortic arch aneurysm meeting one of the above-mentioned criteria.\n* Presence of thoracoabdominal aortic aneurysm meeting one of the above-mentioned criteria with unilateral or bilateral common iliac artery aneurysm with diameter ≥ 3.0-cm or saccular morphology with no suitable landing zone proximal to iliac bifurcation.\n\nGeneral Exclusion Criteria:\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* 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* Patients with ruptured aortic aneurysms requiring urgent or emergent repair, with the exception of patients with contained, stable ruptures with anatomy suitable for an off-the-shelf design.\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* Leaking or ruptured aneurysm associated with hypotension\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, Marfans syndrome), with the exception of 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 forms of Ehlers Danlos).\n* Body habitus that would inhibit X-ray visualization of the aorta and its branches.\n\nAnatomical 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: a. A diameter measured outer wall to outer wall of no greater than 42mm and no less than 21 mm; b. 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 Zenith t-Branch or patient-specific stent-graft 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: a. Common iliac artery fixation site diameter, measured outer wall to outer wall on a sectional image (CT) \\\u003C8.0 mm with inability to perform open surgical conduit ; b. Iliac artery diameter, measured outer wall to outer wall on a sectional image (CT) \\>20 mm at distal fixation site, with inability to perform open internal iliac artery revascularization or iliac branch stent graft ; c. Non-aneurysmal external liac artery distal fixation site \\\u003C10 mm in length ; d. Non-aneurysmal internal iliac artery main trunk or branch segment with length \\\u003C10mm or with inner wall diameter \\\u003C4 or \\>14mm; e. Unsuitable anatomy due to inability to preserve at least one hypogastric artery\n\nAdditional anatomical inclusion criteria for aortic arch devices:\n\n* Proximal aortic fixation zone: a. Native aorta or surgical graft; b. Diameter: 20-42mm; c. Proximal neck length ≥ 20mm; d. Ascending aortic length ≥50mm; e. Must occur distal to coronary arteries and any coronary artery bypass grafts that are considered patent and necessary for proper cardiac perfusion\n* Distal aortic fixation zone:; a. Native aorta or surgical graft; b. Diameter: 20-42mm; c. Distal neck length ≥20mm\n* Supra-aortic trunk (brachiocephalic) vessels: a. Although the prosthesis will typically have two branches, modifications to the design will allow for a single branch, three branches or combination of branch and scallop if a customized version is required. Thus, it is generally planned that at least one extra-anatomic bypass graft will be done in conjunction (or in a staged fashion) with the procedure, unless three branches are planned. The two vessels incorporated into the endograft repair would most commonly be the innominate artery and left common carotid artery. However, the innominate artery may be coupled with the left subclavian artery in the setting of a bovine arch whereby the flow to the left carotid would come from a left subclavian to carotid bypass. Similarly, the left carotid and subclavian artery may be branched, or simply one vessel branched should specific anatomic limitations exist. In such a situation, multiple extra-anatomic bypasses may be necessary. A design with a single subclavian retrograde branch and double scallop to the left carotid artery may be used to extent the landing zone to Zone 1. Finally, a design with two antegrade inner branches for the innominate and left common carotid, and one retrograde inner branch for the left subclavian artery may be used in select cases. Thus the inclusion criteria are defined for each artery, yet any combination of arteries may be used for a repair: Innominate artery (Native vessel or surgical graft, Diameter: 8-22mm, Length of sealing zone ≥10mm, Acceptable tortuosity); Left (or right) common carotid artery (Native vessel or surgical graft, Diameter 6-16mm, Length of sealing zone ≥10mm, Acceptable tortuosity); Left (or right) common carotid artery (Native vessel or surgical graft, Diameter: 5-20mm, Length of sealing zone ≥10mm, Acceptable tortuosity).\n* In the setting of an aortic dissection the following criteria must exist: a. Access into the true lumen from the groin and at least one supra-aortic trunk vessel; b. A sealing 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; c. A sealing zone in the target supra-aortic trunk vessels that is distal to the dissection, anticipated to seal off the dissection lumen, or surgically created; d. A true lumen size large enough to deploy the device and still gain access into the target branches\n* In the setting of more distal disease: a. The repair may be coupled with a thoracoabdominal branched device, infrarenal device, and\u002For internal iliac branch device.\n* Iliac anatomy must allow for the delivery of the arch branch device which is loaded within a 20F-24F sheath. Thus the iliac requirements are no different than the standard thoracic protocol. Conduits to the iliac vessels or aorta may be used if deemed necessary.",{"count":82,"type":19},760,[58],"The purpose of this study is to gather safety and effectiveness of the Zenith t-Branch and customized physician-specified stent-graft with a combination of fenestrations and\u002For branches to repair aortic aneurysm.",[23,24,25,86],"Aortic Arch Dissection",[88,89],"aneurysm","aortic aneurysm","2026-01-16",{"date":92,"type":37},"2026-01-20",{"date":94,"type":37},"2014-03",{"date":96,"type":19},"2032-05",{"name":98,"class":72},"Baylor College of Medicine"]