[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"aortic-arch-dissection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:aortic-arch-dissection":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,43,74],{"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":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":20,"phases":54,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"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":53,"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.",[26,25,57,58],"Chronic Aortic Dissection","Acute Aortic Dissection",[60,61,62,63],"total arch replacement","frozen elephant trunk","aortic arch aneurysm","aortic arch dissection","2026-05-19",{"date":66,"type":34},"2026-05-22",{"date":68,"type":34},"2025-11-04",{"date":70,"type":19},"2032-07",{"name":72,"class":41},"Artivion Inc.",19,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":20,"phases":83,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"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,[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.",[86,87,26,25],"Complex Abdominal Aortic Aneurysm","Thoracoabdominal Aortic Aneurysm",[89,90],"aneurysm","aortic aneurysm","2026-01-16",{"date":93,"type":34},"2026-01-20",{"date":95,"type":34},"2014-03",{"date":97,"type":19},"2032-05",{"name":99,"class":100},"Baylor College of Medicine","OTHER"]