[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-aortic-dissection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-aortic-dissection":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,50,73],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100599829","clinical-study-to-evaluate-the-safety-and-effectiveness-of-arcevo-lsa-100599829",false,"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","ALL","18 Years","80 Years",{"count":21,"type":22},132,"ESTIMATED","INTERVENTIONAL",[25],"NA","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.",[28,29,30,31],"Aortic Arch Aneurysm","Aortic Arch Dissection","Chronic Aortic Dissection","Acute Aortic Dissection",[33,34,35,36],"total arch replacement","frozen elephant trunk","aortic arch aneurysm","aortic arch dissection","RECRUITING","2026-05-19",{"date":40,"type":41},"2026-05-22","ACTUAL",{"date":43,"type":41},"2025-11-04",{"date":45,"type":22},"2032-07",{"name":47,"class":48},"Artivion Inc.","INDUSTRY",19,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":72},"100543264","genetic-architecture-of-acute-aortic-syndromes-and-aortic-aneurysm-100543264","NCT06353607","Genetic Architecture of Acute Aortic Syndromes and Aortic Aneurysm.","Inclusion Criteria:\n\n* All adult patients \\> 18 years who underwent surgery for aAD or TAA intervention at the University Hospital Basel, starting in 2015.\n* All patients who will undergo surgery for aAD or TAA at the University Hospital Basel, beginning in 2024.\n\nExclusion Criteria:\n\n* Patients will be excluded if they are not able or not willing to provide informed consent.\n* Patients with diagnosed heritable vascular disorders, such as Marfan syndrome, Turner Syndrome, Loeyes Dietz and Ehlers-Danlos syndrome.",{"count":57,"type":22},730,"OBSERVATIONAL","The aim of this study is to explore the genetic information associated with the development of TAA and aAD in individuals without history or syndromic features (Marfan syndrome, Ehlers-Danlos syndrome, Turner syndrome etc.) for aortic disease. For this purpose, whole genome sequencing will be performed in patients with documented aortic aneurysm or\u002Fand aortic dissection.",[31,61],"Thoracic Aortic Aneurysm","2025-05-15",{"date":64,"type":41},"2025-05-16",{"date":66,"type":41},"2024-04-08",{"date":68,"type":22},"2028-12-31",{"name":70,"class":71},"University Hospital, Basel, Switzerland","OTHER",1,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":17,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":23,"phases":84,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":72},"100553968","a-triple-branched-stent-graft-for-aute-debakey-type-i-dissection-surgery-100553968","NCT06492980","A Triple-branched Stent Graft for Aute Debakey Type I Dissection Surgery","Safety and Effectiveness of a Triple-branched Stent Graft for Arch Repair During Open Aute Debakey Type I Dissection Surgery - a Randomized Controlled Multicenter Clinical Trial","Inclusion Criteria:\n\n1. Patients with acute type I aortic dissection who need arch repair;\n2. Aged ≥20 years and ≤65 years;\n3. Acute phase, with onset within 14 days before surgery;\n4. Subjects who can understand the purpose of the trial, voluntarily participate and sign the informed consent form, and are willing to accept follow-up.\n\nExclusion Criteria:\n\n1. The presence of anatomical variations, such as aortic arch malformation, aortic coarctation; common origin of the innominate artery and the left common carotid artery, aberrant right subclavian artery, abnormal origin of the left conical artery, stenosis or distortion of the branch arteries; and the diameter of the aortic arch and branch artery diameters do not match the specifications of the test device;\n2. Dissection is secondary to a history of aortic treatment, Marfan syndrome, etc.\n3. Aortic lesions and branch artery lesions caused by acute type I aortic dissection, including aortic pre-rupture, branch artery rupture, branch artery occlusion, and severe ischemic complications caused by poor organ perfusion, such as myocardial ischemia, stroke (ischemic brain injury), paraplegia (spinal artery ischemia), mesenteric artery ischemia, renal artery dysplasia, etc.\n4. Severe infectious lesions that are not controlled;\n5. Patients who need to receive other concomitant treatments, such as severe hypertension, chronic obstructive pulmonary disease, coronary heart disease, chronic kidney disease and other serious underlying lesions that require long-term treatment;\n6. Patients with other life-threatening lesions, such as advanced malignant tumors, and whose expected survival time is less than one year;\n7. Patients with other lesions in the heart and aorta (patients with other heart diseases that require concurrent heart surgery, such as coronary heart disease, mitral valve disease, tricuspid valve disease, etc.), who are not suitable for stent interventional treatment, such as peripheral vascular disease and blood disease;\n8. Subjects who have participated in other drug or device clinical trials and have not reached the primary study endpoint; and pregnant women.","20 Years","65 Years",{"count":83,"type":22},150,[25],"Prospective, multicenter, randomized controlled clinical trial plan to evaluate the effectiveness and safety of intraoperative stent system in the treatment of acute type I aortic dissection",[31],"2024-07-02",{"date":89,"type":41},"2024-07-09",{"date":91,"type":41},"2023-10-27",{"date":93,"type":22},"2025-10-10",{"name":95,"class":71},"Fujian Medical University"]