[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"aortic-arch-aneurysm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:aortic-arch-aneurysm":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,43,68,98,128,150,175,219,252,278,306],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100605716","gore-tag-thoracic-branch-endoprosthesis-zone-01-post-approval-study-100605716",false,"NCT07166133","GORE® TAG® Thoracic Branch Endoprosthesis Zone 0\u002F1 Post-Approval Study","Inclusion Criteria:\n\n1. Patient or legally authorized representative (LAR) provides written authorization and\u002For consent per institution and geographical requirements.\n2. Patient has been or is intended to be treated with the TBE Device in Zone 0 or Zone 1.\n3. Patient is age ≥ 18 years at time of informed consent signature.\n\nExclusion Criteria:\n\n1. Patient who is, at the time of consent, unlikely to be available for defined follow-up visits.\n2. Patient with exclusion criteria required by local law.\n3. Patient is currently enrolled in or plans to enroll in any concurrent investigational drug and\u002For investigational device study within 12 months of study enrollment. Subjects cannot be enrolled in another Gore study.","ALL","18 Years",{"count":18,"type":19},125,"ESTIMATED","INTERVENTIONAL",[22],"NA","A prospective multi-center post-market study collecting outcomes through at least 5-years and up to 10-years post procedure for subjects treated with the TBE Device in Zone 0\u002F1 as part of routine clinical practice.",[25,26],"Aortic Arch Dissection","Aortic Arch Aneurysm",[28,29],"Zone 0","Zone 1","RECRUITING","2026-06-19",{"date":33,"type":34},"2026-06-23","ACTUAL",{"date":36,"type":34},"2026-03-02",{"date":38,"type":19},"2036-03",{"name":40,"class":41},"W.L.Gore & Associates","INDUSTRY",7,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":20,"phases":51,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":67},"100172879","evaluation-of-branch-endografts-in-the-treatment-of-aortic-aneurysms-100172879","NCT01524211","Evaluation of Branch Endografts in the Treatment of Aortic Aneurysms","Zenith t-Branch Eligibility Criteria:\n\nInclusion Criteria\n\nThe patient must have one of the following:\n\n1. Degenerative, atherosclerotic thoracoabdominal, suprarenal and juxtarenal aortic aneurysms (fusiform or saccular):≥55mm in diameter in a male or ≥50mm in diameter in a female, or\n2. Thoracoabdominal aortic aneurysm with a history of growth ≥0.5 cm per year, or\n3. Penetrating ulcers: ≥20mm in depth or\n4. Chronic type B aortic dissections: ≥50mm total aortic diameter or\n5. Symptomatic pathology (aneurysm, ulcer or chronic dissection) of any size.\n\nAdditional criteria for LP material\n\n• Iliofemoral access vessels \\\u003C8mm or with significant atherosclerotic occlusive disease that would require an iliac conduit as determined by the Principle Investigator\n\nExclusion Criteria\n\nGeneral Criteria\n\n1. Life-expectancy less than 12 months\n2. Refusal to receive blood products\n3. Age \\\u003C18 years\n4. Pregnant or breastfeeding or planning on becoming pregnant within 60 months\n5. Unwilling to comply with the follow-up schedule\n6. Inability or refusal to give informed consent by subject and\u002For Legally Authorized Representative (LAR); should one be utilized\n\nMedical Criteria\n\n1. Uncontrolled systemic infection\n2. Untreatable malignancy\n3. Uncontrollable anaphylaxis to iodinated contrast\n4. Known allergy(ies) to device materials\n\nAnatomic Criteria\n\n1. Any pathology of mycotic origin\n2. Aortic fistulous communication with non-vascular structure (e.g. esophagus, bronchial)\n3. Inability to insert the Zenith® t-Branch device through iliofemoral approach\n4. Proximal and distal neck angle less than 90 degrees relative to the long axis of the aneurysm\n5. Proximal landing zone length \\\u003C25mm to allow secure fixation and seal\n6. Proximal landing zone diameter of \\\u003C24mm or \\>42mm\n7. Distal landing zone length \\\u003C25mm in the abdominal aorta or \\\u003C20mm in the iliac arteries\n8. Distal landing zone diameter of \\\u003C14mm or \\>30mm in the abdominal aorta, or \\\u003C7mm or \\>28mm in the iliac arteries\n\nTerumo Arch Branch Eligibility Criteria\n\nInclusion Criteria\n\nThe subject must have one of the following:\n\n1. Degenerative, atherosclerotic aneurysm involving the ascending aorta, aortic arch or proximal descending aorta ≥55 mm in diameter or \\> 50 mm with a history of growth ≥5 mm in the last 6 months, or\n2. Penetrating ulcers: ≥20 mm in depth, or\n3. Chronic aortic dissections: ≥50mm total aortic diameter. AND Prohibitive or high-risk for standard open surgical repair, defined as having one or more of the following pre-existing conditions.\n\n   1. Age \\>85 years old.\n   2. Prior median sternotomy (for any reason).\n   3. Prior open or endovascular thoracic aortic repair.\n   4. Severe aortic calcification.\n   5. Severe occlusive disease of one or more arch vessels.\n   6. Moderate-severe COPD (FEV1 \\\u003C80% predicted).\n   7. Severe CKD (Stage 3 or greater, eGFR \\\u003C60 mL\u002Fmin).\n   8. LV dysfunction.\n   9. Chronic steroid or immunosuppressive use.\n   10. History of increased risk of bleeding.\n   11. Neurocognitive deficits that may significantly impact postoperative rehabilitation.\n   12. Musculoskeletal conditions that may significantly impact postoperative rehabilitation.\n\nExclusion Criteria\n\nGeneral Criteria\n\n1. Life expectancy \\\u003C1 year.\n2. Refusal to receive blood products.\n3. Age \\\u003C18 years.\n4. Pregnant, breastfeeding, or planning to become pregnant within 60 months.\n5. Unwilling to comply with the follow-up schedule.\n6. Inability or refusal to give informed consent by subject and\u002For Legally Authorized Representative (LAR); should one be utilized.\n7. Willingness to travel, if needed, to participate in a manufacturer-sponsored clinical trial at another institution.\n\nMedical Criteria\n\n1. Pending cardiac surgery.\n2. Untreatable severe, symptomatic coronary or valvular disease.\n3. Prior mechanical aortic valve replacement (not bioprosthetic).\n4. History of TAVR (Transcatheter Aortic Valve Replacement)\n5. Severe, calcific aortic valvular stenosis.\n6. Uncontrolled systemic infection.\n7. Untreatable malignancy with \\\u003C1 year expected survival.\n8. Uncontrollable anaphylaxis to iodinated contrast.\n9. Known allergy(ies) to device materials. (i.e. polyester, nitinol).\n\nAnatomic Criteria\n\n1. Any pathology of mycotic origin.\n2. Aortic fistulous communication with non-vascular structure (e.g. esophagus, bronchial).\n3. Acute (\\\u003C2 weeks) aortic dissection.\n4. Type A dissection.\n5. Symptomatic or ruptured pathology.\n6. Anatomy suitable for repair using commercially-available endograft.\n7. Inability to insert the Arch Branch endograft through an iliofemoral approach.\n8. Untreated, known extracranial carotid stenosis \\>80%.\n9. Ascending aortic angulation with radius of curvature \\\u003C15mm in the intended landing zone.\n10. Proximal aortic landing zone length \\\u003C25 mm.\n11. Proximal aortic landing zone diameter of \\>43mm or \\\u003C28 mm.\n12. Distal aortic landing zone diameter \\\u003C20 mm.\n13. Total length along the outer curve from the distal coronary to the proximal edge of the brachiocephalic trunk \\\u003C70mm.\n14. Target arch vessels:\n15. Distal branch landing zone dimensions: I. Brachiocephalic trunk (innominate artery, BCT): Diameter \\>24 mm or \\\u003C6 mm, length \\\u003C15 mm. ii. Common carotid artery: Diameter \\\u003C6 mm, length \\\u003C25mm. iii. Subclavian artery: Diameter \\\u003C6 mm, length \\\u003C25mm.",{"count":50,"type":19},235,[22],"Zenith t-Branch Study Cohort: The purpose of this study is to collect information on the Cook Zenith t-Branch endovascular stent-graft system and the Terumo Arch Branch for the treatment of aortic aneurysms.\n\nTerumo Arch Branch Study Cohort: The purpose of this additional study arm to the current IDE clinical trial is to collect a priori information on the Terumo Arch Branch Endograft for the treatment of proximal thoracic aortic pathologies that cannot be treated with conventional thoracic endografts.",[54,26],"Thoracoabdominal Aortic Aneurysm",[56],"Aortic Aneurysms","2026-06-12",{"date":59,"type":34},"2026-06-15",{"date":61,"type":34},"2012-01-25",{"date":63,"type":19},"2032-01",{"name":65,"class":66},"Baptist Health South Florida","OTHER",1,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":77,"phases":4,"briefSummary":78,"conditions":79,"keywords":82,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":97},"100508130","european-aortic-data-collection-project-100508130","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.",{"count":76,"type":19},600,"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.",[80,54,26,81],"Complex Abdominal Aortic Aneurysm","Chronic Aortic Dissection",[83,84,85,86,87],"Complex aortic repair","Aortic aneurysm","Aortic dissection","Fenestrated\u002Fbranched endograft","Custom-made endovascular graft","2026-06-03",{"date":90,"type":34},"2026-06-04",{"date":92,"type":34},"2023-05-31",{"date":94,"type":19},"2030-12",{"name":96,"class":41},"Cook Research Incorporated",18,{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":106,"enrollmentInfo":107,"targetDuration":4,"studyType":20,"phases":109,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":127},"100599829","clinical-study-to-evaluate-the-safety-and-effectiveness-of-arcevo-lsa-100599829","NCT07089576","Clinical Study to Evaluate the Safety and Effectiveness of Arcevo LSA","A Prospective, Multi-center Clinical Study to Evaluate the Safety and Effectiveness of Arcevo LSA in the Open Repair of Aortic Arch Aneurysms and Dissections","ARTIZEN","General Inclusion Criteria\n\n1. ≥18 years of age or ≤80 years of age (male or female) at time of surgery\n2. Patient has one of the following indications for open surgery based on computed tomography angiography (CTA) completed within 90 days of informed consent:\n\n   * Acute, subacute, or chronic dissection that involves the aortic arch and the descending thoracic aorta, with or without involvement of the ascending aorta\n   * Aneurysm that involves the aortic arch and the descending thoracic aorta, with or without involvement of the ascending aorta\n3. Patient, or patient's legally authorized representative (LAR; in the secondary arm only), provides written informed consent prior to any study procedures\n4. Patient's surgery occurs within 90 days of informed consent\n\n   Anatomical Inclusion Criteria\n5. Aortic diameter at the intended Arcevo™ LSA anastomosis site is ≥ 21 mm\n6. For Aneurysm with distal sealing (i.e., single stage procedure), aortic diameter at the intended distal sealing zone is between 20-36 mm\n7. For Dissection with distal sealing, aortic diameter at the intended distal sealing zone is between 22-40 mm\n8. LSA branch does not require additional stenting further into the LSA (beyond the Arcevo™ LSA)\n9. The intended LSA sealing zone has a diameter between 8.5 mm and 14.0 mm with a length of at least 10 mm\n10. Absence of dissection, aneurysm, or stenosis in the intended LSA sealing zone\n11. The intended LSA branch position does not interrupt flow to any branch vessel (e.g., left vertebral artery)\n12. Patient does not have computed tomography (CT) evidence of extreme arch or LSA angulation precluding safe passage of the Arcevo™ LSA and delivery system\n13. LSA take-off angle between 15° and 90°\n14. For patients requiring planned extension, there is a ≥ 2 cm distal seal zone for the TEVAR device without a severely angulated descending aorta\n15. For patients requiring planned extension, patient has suitable iliac artery anatomy for safe passage of the TEVAR delivery system\n\nGeneral Exclusion Criteria\n\n1. Patient is pregnant, or planning to become pregnant during the course of the study; individuals of child-bearing potential must agree to use acceptable methods of contraception during the study\n2. Patient has another medical condition (aside from the arch disease) that, in the opinion of the investigator, reduces the patient's life expectancy to \\\u003C 2 years\n3. Patient has an existing aortic stent graft device in the descending aorta that would interact with Arcevo™ LSA\n4. Patient has a medical, social, or psychological problem that, in the opinion of the investigator, could impede the patient's ability to return for follow-up\n5. Patient is unwilling or unable to comply with the follow-up schedule\n6. Patient is institutionalized due to administrative or judicial order\n7. Patient is unwilling to accept blood transfusion or blood product\n8. Patient is currently participating in another interventional clinical study which includes treatment with another investigational product (e.g., device, pharmaceutical or biologic)\n\n   Medical Exclusion Criteria\n9. Patient is unfit for open surgical repair involving circulatory arrest\n10. Patient is in extreme hemodynamic compromise requiring cardiopulmonary resuscitation (CPR) or substantial inotropic support prior to surgery\n11. Patient has an active systemic infection\n12. Patient has endocarditis or active infection of the aorta\n13. Patient has a freely ruptured aorta\n14. Patient has a history of a bleeding disorder (e.g., hemophilia)\n15. Patient has current end-stage renal disease (e.g., GFR \\\u003C30 mL\u002Fmin)\n16. Patient has a known allergy to Arcevo™ LSA components and TEVAR device components (if required) (nitinol, polyester, platinum-iridium, or polyethylene)\n17. Patient has uncontrollable anaphylaxis to iodinated contrast or other inability to obtain CT angiograms during follow-up\n18. Patient has acute coronary malperfusion\n19. Patient has symptomatic visceral malperfusion","80 Years",{"count":108,"type":19},132,[22],"The goal of this clinical trial is to learn if the Arcevo LSA stent graft can safely and effectively treat patients that have an acute or chronic aortic dissection and\u002For aneurysm that involves the aortic arch and the descending thoracic aorta, with or without the involvement of the ascending aorta.",[26,25,81,112],"Acute Aortic Dissection",[114,115,116,117],"total arch replacement","frozen elephant trunk","aortic arch aneurysm","aortic arch dissection","2026-05-19",{"date":120,"type":34},"2026-05-22",{"date":122,"type":34},"2025-11-04",{"date":124,"type":19},"2032-07",{"name":126,"class":41},"Artivion Inc.",19,{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":106,"enrollmentInfo":135,"targetDuration":4,"studyType":20,"phases":137,"briefSummary":138,"conditions":139,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":149},"100545705","guos-aortic-arch-reconstruction-a-multicenter-prospective-study-of-the-novel-weflow-tribranch-system-genius-study-100545705","NCT06385379","Guo's Aortic Arch Reconstruction: A Multicenter, Prospective Study of the Novel WeFlow-Tribranch System (GENIUS Study)","Guo's Aortic Arch Reconstruction: A Multicenter, Prospective Study of the Novel WeFlow-Tribranch Unique Embedded Aortic Triple-branch Arch Stent Graft System (GENIUS Study)","Inclusion Criteria:\n\n1. Patients aged 18 to 80 years old;\n2. Diagnosed with aortic arch lesions requiring intervention, including true aortic arch aneurysms, pseudo-aortic arch aneurysms, and ulcers involving the aortic arch;\n3. Showing a suitable vascular condition, including:\n\n   * Ascending aorta length greater than 50 mm (from the aortic sinusoid junction to the proximal cardiac margin of the innominate artery).\n   * Ascending aorta diameter ≥ 24 mm and ≤ 48 mm;\n   * Proximal anchoring zone length ≥ 30 mm;\n   * Branch arteries to be reconstructed were ≤ 24 mm and ≥ 6 mm in diameter and ≥ 20 mm in length;\n   * Suitable arterial access for endovascular interventional treatment;\n4. Able to understand the purpose of the trial, participate in the trial voluntarily with informed consent form signed by the patient him\u002Fherself or his or her legal representative, and willing to complete follow-up visits as required under the protocol.\n5. Subjects were assessed as high risk for surgery by at least two investigators or judged to have significant surgical contraindications. Recommended reference criteria were a European system for cardiac operative risk evaluation (EuroScore) score of 6 or higher or other surgical risk factors as judged by the physician team.\n\nExclusion Criteria:\n\n1. Experienced systemic infection during past three months;\n2. Neck surgery was performed within 3 months;\n3. Previous endovascular interventional treatment involving the aortic arch was performed;\n4. Infectious aortic disease, Takayasu arteritis, Marfan syndrome (or other connective tissue diseases );\n5. Severe stenosis, calcification, thrombosis, or tortuosity of the branch artery to be reconstructed;\n6. Heart transplant;\n7. Suffered Myocardial Infarction or Stroke during past three months;\n8. Class IV heart function (NYHA classification);\n9. Active peptic ulcers or upper gastrointestinal bleeding occurring within the previous three months;\n10. Hematological abnormality, defined as follows: Leukopenia (WBC \\\u003C 3 ×109\u002FL), acute anemia (Hb \\\u003C 90 g\u002FL), Coagulation disorders, thrombocytopenia (PLT count \\\u003C 50 × 109\u002FL);\n11. Renal insufficiency, creatinine \\> 150 umol\u002FL and\u002For end-stage renal disease requiring renal dialysis;\n12. Pregnant or breastfeeding;\n13. Allergies to contrast agents;\n14. Life expectancy of less than 12 months;\n15. Participating in another drug or device research;\n16. Any other disease or abnormality that the investigators believe may hinder endovascular interventional treatment.",{"count":136,"type":19},90,[22],"A prospective ,Multiple Center Study About the Safety and Efficacy of WeFlow-Tribranch Embedded Aortic Triple-branch Arch Stent Graft System manufactured by EndoNom Medtech (Hangzhou) Co., Ltd. for true\u002Fpseudo aortic arch aneurysms and ulcers involving aortic arch . (GENIUS Study)",[26],"2026-04-27",{"date":142,"type":34},"2026-05-01",{"date":144,"type":34},"2024-06-30",{"date":146,"type":19},"2030-12-31",{"name":148,"class":41},"Hangzhou Endonom Medtech Co., Ltd.",20,{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":4,"eligibilityCriteria":156,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":157,"targetDuration":4,"studyType":20,"phases":159,"briefSummary":160,"conditions":161,"keywords":162,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":174},"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":158,"type":19},760,[22],"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.",[80,54,26,25],[163,164],"aneurysm","aortic aneurysm","2026-01-16",{"date":167,"type":34},"2026-01-20",{"date":169,"type":34},"2014-03",{"date":171,"type":19},"2032-05",{"name":173,"class":66},"Baylor College of Medicine",3,{"id":176,"slug":177,"hasResults":11,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":4,"eligibilityCriteria":181,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":20,"phases":184,"briefSummary":185,"conditions":186,"keywords":191,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":67},"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":183,"type":19},410,[22],"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.",[187,188,54,189,26,190],"Juxtarenal Aortic Aneurysm","Suprarenal Aortic Aneurysm","Penetrating Aortic Ulcer","Aortic Dissection",[192,193,194,195,196,197,198,199,200,201,202,203,204,205,206,207,208,209],"Endovascular","Aortic","Aneurysm","Thoracoabdominal","Juxtarenal","Suprarenal","Endograft","Fenestrated","Branched","Complex","Abdominal","Thoracic","Stent","Stentgraft","Arch","Ascending","Dissection","Descending","2026-01-02",{"date":212,"type":34},"2026-01-06",{"date":214,"type":34},"2014-06",{"date":216,"type":19},"2027-10",{"name":218,"class":66},"University of Alabama at Birmingham",{"id":220,"slug":221,"hasResults":11,"nctId":222,"briefTitle":223,"officialTitle":223,"acronym":224,"eligibilityCriteria":225,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":226,"targetDuration":4,"studyType":20,"phases":227,"briefSummary":228,"conditions":229,"keywords":237,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":247,"completionDateStruct":248,"leadSponsor":250,"locationsCount":67},"100213022","complex-aortic-aneurysm-repair-using-physician-modified-endografts-and-custom-made-devices-100213022","NCT02050113","Complex Aortic Aneurysm Repair Using Physician Modified Endografts and Custom Made Devices","CARPE-CMD","Inclusion Criteria:\n\n* A patient may be suitable for inclusion in the study if the patient has at least one of the following:\n\n  1. Aortic or aortoiliac aneurysm with diameter ≥5.5 cm\n  2. Aortic or aortoiliac aneurysm with a history of growth ≥1.0 cm per year, or clinical indication for aneurysm repair based on symptoms\n\n     General Inclusion Criteria\n\n  \u003C!-- -->\n\n  1. Cannot be treated with a currently available non-modified approved device\n  2. Symptomatic on presentation and unsafe to wait for the time necessary to obtain a currently available non-modified approved device\n  3. At least 18 years of age\n  4. Not pregnant or breastfeeding\n  5. Willing and able to comply with five years of follow-up\n  6. Willing and able to provide informed consent prior to enrollment\n  7. No systemic or local infection that may increase the risk of endovascular graft infection\n  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. 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\n\n     Exclusion Criteria:\n* Exclusion Criteria Medical Exclusion Criteria\n\n  1. Cultural objection to receipt of blood or blood products\n  2. Allergy or sensitivity to stainless steel, polyester, polypropylene, solder (tin, silver), gold, or nitinol\n  3. Anaphylactic reaction to contrast that cannot be adequately pre-medicated\n  4. Uncorrectable coagulopathy\n  5. Unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina, or onset of prolonged angina)\n  6. Patient has active malignancy with life expectancy of less than 2 years\n  7. Patient has life expectancy less than two years\n\nAnatomical Exclusion Criteria\n\n1. Significant occlusive disease, tortuosity, or calcification that would prevent endovascular access\n2. Proximal neck length ≤25 mm\n3. Proximal neck, measured outer wall to outer wall on a sectional image (CT)\n\n   1. For use of Zenith Flex: diameter \\>32 mm or \\\u003C18 mm\n   2. For use of Zenith TX2: diameter \\>38 mm or \\\u003C24 mm (for proximal and distal neck diameter)\n4. Proximal neck angulated more than 60 degrees relative to the long axis of the aneurysm\n5. Proximal neck diameter change over the length of the proximal seal zone \\>4 mm\n6. Proximal seal site with a circumferential thrombus\u002Fatheroma\n7. 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)\n8. Ipsilateral iliac artery fixation site diameter, measured inner wall on a sectional image (CT) \\>21 mm at distal fixation site\n9. Iliac artery distal fixation site \\\u003C10 mm in length\n10. Non-bifurcated segment of any artery to be stented \\\u003C 15 mm in length\n11. Artery to be stented with a maximum diameter \\\u003C3 mm or \\>10 mm at the vessel ostium\n12. Inability to maintain at least one patent hypogastric artery",{"count":76,"type":19},[22],"The purpose of this study is to evaluate the safety and efficacy of custom made devices, Zenith t-Branch devices and physician modification of FDA approved off-the-shelf endovascular grafts in the treatment of patients with complex abdominal aneurysms, aortoiliac aneurysms, thoracoabdominal aneurysms and aortic arch aneurysms who (1) have anatomy not suitable for endovascular repair using grafts currently marketed in the United States,(2) are deemed unsafe to wait the required time necessary for commercial endograft manufacturing, and (3) are at high risk for open surgical repair. Amendment to the study has created a cohort open to people with connective tissue diseases such as Marfan, Ehlers-Danlos or Loey-Dietz syndromes to enroll in the trial. An additional amendment to the study allows the use of a custom made device to treat an aneurysm in the aortic arch.",[230,231,232,233,234,235,236,26],"Complex Aortic Aneurysms","Thoracoabdominal Aneurysms","Pararenal Aneurysms","Juxtarenal Aneurysms","Marfan Syndrome","Ehlers-Danlos Syndrome","Loeys-Dietz Syndrome",[230,231,238,239,240,241,242,192,190,243],"Pararenal Aortic Aneurysms","Juxtarenal Renal Aneurysms","Endovascular Branch Graft","Fenestrated Stent Graft","Abdominal Aortic Aneurysm","Aortic Arch Aneurysms","2025-10-20",{"date":246,"type":34},"2025-10-22",{"date":169,"type":4},{"date":249,"type":19},"2030-03",{"name":251,"class":66},"Andres Schanzer",{"id":253,"slug":254,"hasResults":11,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":4,"eligibilityCriteria":258,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":106,"enrollmentInfo":259,"targetDuration":4,"studyType":20,"phases":261,"briefSummary":262,"conditions":263,"keywords":264,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":277},"100556106","concave-supra-arch-branched-stent-graft-system-for-endovascular-treatment-of-aortic-arch-diseases-100556106","NCT06520774","Concave Supra-arch Branched Stent-Graft System for Endovascular Treatment of Aortic Arch Diseases","A Prospective, Multicenter, Single-Group Target-Value Clinical Trial: Concave Supra-arch Branched Stent-Graft System for Endovascular Treatment of Aortic Arch Diseases","Inclusion Criteria:\n\n1. Patients who are aged 18 to 80 years inclusive；\n2. Patients diagnosed with aortic arch aneurysms or penetrating ulcers that require intervention, and for whom the proximal end of the stent needs to be anchored in the Z0 zone;\n3. Anatomical criteria, including:\n\n   1. Ascending aorta length is greater than or equal to 50 mm (distance from aortic sinus to anterior edge of innominate artery);\n   2. The diameter range of the anchoring area at the proximal end of the main body is between 25-45 mm and the length is greater than or equal to 30 mm;\n   3. The diameter of the anchored area of supra-arch branch vessels (innominate artery, left common carotid artery, left subclavian artery) is between 5-18 mm, distal anchorage length is greater than or equal to 15 mm;\n   4. Distance between the anterior edge of the innominate artery to the posterior edge of the left subclavian artery is less than or equal to 80 mm;\n   5. Have a suitable iliac, femoral, and superior arch arterial access;\n4. At least two researchers should assess that the subject is a high-risk patient for surgical treatment or has significant contraindications to surgery. It is recommended to refer to the following criteria: a score of ≥6 in the European System for Cardiac Operative Risk Evaluation (EuroSCORE) scoring system.;\n5. Patients who understand the purpose of the study, volunteer to participate and sign the informed consent form, and are willing to complete follow-up visits as required by the protocol.\n\nExclusion Criteria:\n\n1. Patients either with ruptured or infected aneurysms;\n2. Patients with aortic dissection;\n3. Patients with general or local infections that may increase the risk of endovascular graft infection;\n4. Patients with severe stenosis, calcification, or mural thrombus in the stent anchoring area, which is likely to impede stent-graft adherence or affect stent patency;\n5. Previous endovascular intervention involving the aortic arch;\n6. Underwent open or endovascular surgery for abdominal aorta within the past 3 months;\n7. Patients with a history of stroke within the past 3 months (excluding TIA);\n8. Patients with aneurysms involving the distal descending aorta and requiring reconstruction of important visceral branch vessels within the abdomen;\n9. Patients with a history of myocardial infarction within the past 3 months;\n10. Patients with congestive heart failure - NYHA Class IV;\n11. Patients allergic to contrast agents, stent and delivery system materials (such as nitinol, polyester, PTFE, nylon polymer materials);\n12. Patients with contraindications to anticoagulant or antiplatelet drugs;\n13. Patients unable to tolerate general anesthesia;\n14. Patients with abnormal liver and kidney function before surgery (ALT or AST more than 5 times the upper limit of normal; serum creatinine (Cr) \\>150umol\u002FL);\n15. Patients with connective tissue diseases, such as Marfan syndrome, Ehlers-Danlos syndrome, or Behcet's disease;\n16. Patients with arteritis;\n17. Patients with a life expectancy of less than 1 year;\n18. Women who are planning to conceive, pregnant or breastfeeding;\n19. Patients deemed by the investigator as unsuitable for endovascular treatment;\n20. Patients who have participated in other clinical studies and have not withdrawn or been excluded within the 3 months prior to the screening period of this study.",{"count":260,"type":19},103,[22],"The objective of the study is to evaluate the safety and efficacy of the Lifetech Concave Supra-arch Branched Stent-Graft System for Endovascular Treatment of Aortic Arch Diseases",[26,189],[265,266,267],"Lifetech","Concave Supra-arch Branched Stent-Graft System","Endovascular Treatment","2025-07-25",{"date":270,"type":34},"2025-07-28",{"date":272,"type":34},"2024-05-30",{"date":274,"type":19},"2031-06-30",{"name":276,"class":41},"Lifetech Scientific (Shenzhen) Co., Ltd.",17,{"id":279,"slug":280,"hasResults":11,"nctId":281,"briefTitle":282,"officialTitle":283,"acronym":284,"eligibilityCriteria":285,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":106,"enrollmentInfo":286,"targetDuration":4,"studyType":20,"phases":288,"briefSummary":289,"conditions":290,"keywords":293,"overallStatus":297,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":304,"locationsCount":67},"100598157","triple-branched-stent-graft-system-for-aortic-arch-lesions-100598157","NCT07067840","Triple Branched Stent Graft System for Aortic Arch Lesions","Safety and Efficacy of the Triple Branched Covered Stent Graft System for the Treatment of Aortic Arch Lesions: a Prospective, Multicenter, Single-Arm Trial.","TRACE","* Inclusion Criteria：\n\n  1. Patients aged 18-80 years.\n  2. Diagnosed with aortic arch lesions that require treatment, including true aortic arch aneurysms, false aortic arch aneurysms, and aortic arch ulcers.\n  3. The investigator determines that the subject is suitable for endovascular therapy.\n  4. The subject understands the purpose of the trial, voluntarily agrees to participate, and is willing to undergo follow-up.\n  5. Anatomical conditions:\n\n     * Ascending aorta length ≥50 mm.\n     * Ascending aorta diameter ≥26 mm and ≤46 mm.\n     * Proximal landing zone length ≥20 mm.\n     * Brachiocephalic artery diameter ≤19 mm and ≥9 mm, with a length ≥20 mm.\n     * Left common carotid artery and left subclavian artery diameter ≤13 mm and ≥5 mm, with a left common carotid artery length ≥20 mm, and the distance from the left vertebral artery opening to the left subclavian artery opening on the aorta ≥20 mm.\n  6. The investigator assesses the subject as a high-risk patient for open surgery or with significant contraindications to open surgery.\n* Exclusion Criteria\n\n  1. Pregnant or breastfeeding women.\n  2. Patients diagnosed with connective tissue diseases related to the aorta (e.g., Marfan syndrome).\n  3. Infectious aortic diseases or Takayasu arteritis.\n  4. Patients who have undergone endovascular treatment of the ascending aorta or aortic arch.\n  5. Patients with a known allergy to nickel-titanium alloy, contrast agents, or other relevant materials.\n  6. Severe renal failure (creatinine levels more than twice the upper limit of normal; dialysis patients are excluded).\n  7. Hematological abnormalities:\n\n     * Leukopenia (WBC \\\u003C 3×10⁹\u002FL).\n     * Anemia (Hb \\\u003C 70 g\u002FL).\n     * Coagulation disorders: thrombocytopenia (PLT count \\\u003C 50×10⁹\u002FL).\n  8. Heart transplant recipients.\n  9. History of myocardial infarction or stroke within the past 3 months.\n  10. Heart function class IV (NYHA classification).\n  11. Active infections, such as bacteremia or sepsis.\n  12. Patients with an expected survival of less than 12 months.\n  13. Patients with aortic valve replacement with a mechanical valve that would interfere with the safe introduction of the trial device.\n  14. Subjects participating in other drug or medical device clinical trials and have not yet completed the primary endpoints of those trials.\n  15. Poor compliance, with an expectation of inability to attend follow-up visits.\n  16. Other conditions deemed by the investigator as unsuitable for endovascular therapy, such as severe vascular stenosis, calcification, tortuosity, thrombosis, or inability to cooperate.",{"count":287,"type":19},96,[22],"The goal of this clinical trial is to evaluate the safety and efficacy of the Triple Branched Covered Stent Graft System in treating aortic arch lesions. The main questions it aims to answer are:\n\n* Does the Triple Branched Covered Stent Graft System achieve a 12-month treatment success rate that meets or exceeds the predefined target value?\n* What is the 30-day major adverse event (MAE) rate following the use of the Triple Branched Covered Stent Graft System?\n\nResearchers will use a single-arm study design with predefined target values for the primary endpoints to assess the performance of the stent system.\n\nParticipants will:\n\n* Undergo a comprehensive screening process to determine eligibility based on specific inclusion and exclusion criteria.\n* Receive the Triple Branched Covered Stent Graft System implantation as part of the treatment for their aortic arch lesions.\n* Attend follow-up visits at specified intervals (e.g., pre-discharge, 30 days post-surgery, 6 months, 12 months, and annually up to 5 years) for evaluations including imaging studies (CTA) and clinical assessments.\n* Report any adverse events or changes in their health status during the follow-up period.",[26,291,292],"Aortic Arch Pseudoaneurysm","Aortic Arch Ulcer",[294,295,296,164],"triple branched stent graft","aortic arch","aortic ulcer","NOT_YET_RECRUITING","2025-07-07",{"date":300,"type":34},"2025-07-16",{"date":302,"type":19},"2025-09-01",{"date":146,"type":19},{"name":305,"class":66},"Changhai Hospital",{"id":307,"slug":308,"hasResults":11,"nctId":309,"briefTitle":310,"officialTitle":310,"acronym":311,"eligibilityCriteria":312,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":313,"targetDuration":315,"studyType":77,"phases":4,"briefSummary":316,"conditions":317,"keywords":321,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":329,"lastUpdatePostDateStruct":330,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":336,"locationsCount":67},"100480001","outcome-of-a-triple-inner-branched-aortic-arch-stentgraft-a-prospective-multicenter-registry-100480001","NCT05530304","Outcome of a Triple Inner Branched Aortic Arch Stentgraft. A Prospective, Multicenter Registry.","triple_branch","Inclusion Criteria:\n\n* 18 years or older\n* Presence of Aortic arch pathology\n* Treatment planned with triple inner branch from Terumo Aortic\n* Availability of the patients during the follow up period\n* Informing patients about the study and providing written informed consent\n\nExclusion Criteria:\n\n* Women of childbearing age\n* Patients under 18 years",{"count":314,"type":19},30,"1 Year","Outcome of a triple inner branched aortic arch stentgraft. A prospective, mulitcenter registry.",[318,26,319,320],"Aortic Arch","Dissection of Aortic Arch","Triple Branch",[322,323,324,325,326,327,328],"Aortic arch pathologies","Aortic arch aneruysm","Aortic arch dissection","triple branch","stentgraft","Double branch","Inner branch","2023-09-11",{"date":331,"type":34},"2023-09-13",{"date":333,"type":34},"2023-02-09",{"date":335,"type":19},"2027-03-31",{"name":337,"class":66},"University Hospital Muenster"]