[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"thoracic-aortic-dissection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:thoracic-aortic-dissection":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,44,80,107,134],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":4},"100636337","mba-early-feasibility-study-100636337",false,"NCT07564375","MBA Early Feasibility Study","Early Feasibility Study of the GORE® Multibranch Arch Endoprosthesis (MBA Device)","Inclusion Criteria:\n\nThe subject is \u002F has:\n\n1. Thoracic pathologies with involvement of the arch branch vessels, that are compatible with the treatment requirements of the MBA device, and meeting any of the following criteria:\n\n   a) Aneurysm and Isolated Lesions: i. Fusiform aneurysm (≥ 55 mm or documented growth rate \\> 0.5 cm\u002Fyear). ii. Saccular aneurysm (no diameter criteria). iii. Pseudoaneurysms (\\> 30 days post-surgery, no diameter criteria). iv. Penetrating Aortic Ulcers (PAUs) without intramural hematoma (IMH) (no diameter criteria).\n\n   b) Aortic dissection: i. Uncomplicated and high-risk chronic de novo (\\> 90 days) Type B aortic dissection with primary entry tear in the arch or descending thoracic aorta.\n\n   ii. Residual aortic dissection following surgical repair of Type A aortic dissection requiring treatment (\\> 30 days post-treatment).\n\n   iii. Proximal extension of prior endovascular repair (\\> 30 days post-treatment and \\> 90 days post-dissection) of a Type B dissection requiring treatment.\n\n   iv. Pseudoaneurysms, following open surgical repair of a Type A dissection (\\> 30 days post-surgery, no diameter criteria).\n2. Anatomic compatibility with MBA device and other devices required for proximal or distal extensions based on Gore's review.\n\n   1. Adequate vascular access via transfemoral or retroperitoneal approach.\n   2. Appropriate vascular access to allow for through-wire access to the brachiocephalic artery, LCCA, and LSA.\n   3. Proximal Aortic Landing Zone:\n\n   i. Landing zone is native aorta, surgical graft, or previously implanted GORE thoracic stent graft.\n\nii. Landing zone diameter between 27 mm - 48 mm. iii. Acceptable ascending aorta outer curvature length for the required MBA device.\n\n1. Proximal segment length (length from distal edge of brachiocephalic artery to distal edge of the most distal coronary artery) must be ≥ 2 cm longer than the \"AC Proximal End to BCA Portal Length\" for the selected Aortic Component or ≥ 3 cm if the landing zone is \\> 42 mm.\n2. For patients with patent bypass graft from the ascending aorta, proximal extent of landing zone must be ≥ 1 cm distal to the bypass graft.\n\niv. Lesion location is ≥ 2 cm distal to the most distal coronary artery ostium. v. For patients with an existing transcatheter aortic valve replacement (TAVR) there must be a sufficient proximal landing zone to avoid interference with the required MBA device (including any proximal extensions with the ASG device).\n\nvi. Proximal landing zone must be ≥ 2 cm in the ascending aorta.\n\n1. For patients with prior replacement of the ascending aorta and \u002F or aortic arch by surgical graft, there must be ≥ 2 cm overlap of MBA device and previously implanted graft.\n2. For patients with a de novo aortic dissection, the primary entry tear must be located ≥ 2 cm distal to the proximal extent of the MBA device (including any proximal extensions) and the proximal edge of the stent graft must land in non-dissected aorta.\n\n   vii. Landing zone cannot be aneurysmal, heavily calcified, or heavily thrombosed.\n\n   d) Branch Vessel Landing Zone: i. Length of ≥ 2.5 cm proximal to first major branch vessel. ii. Target branch vessel inner diameter of 11-18 mm for the 12 mm portal, and 6-15 mm for the 8 mm portal.\n\n   iii. Target branch vessel landing zone must be in native aorta that cannot be heavily calcified, or heavily thrombosed.\n\n   iv. All three arch target vessels must have appropriate anatomy for cannulation (including through-wire access) and treatment with MBA branch components.\n\n   e) Distal Aortic Landing Zone (aneurysms and isolated lesions only): i. Outer curvature length must be ≥ 2 cm proximal to the celiac artery. ii. Aortic inner diameters between 16-42 mm. iii. Landing zone cannot be aneurysmal, heavily calcified, or heavily thrombosed.\n\n   iv. Landing zone in native aorta, surgical graft, or previously implanted GORE thoracic stent graft.\n3. Age ≥ 18 years at time of informed consent signature.\n4. Informed Consent Form (ICF) signed by the subject or legally authorized representative (LAR), according to local regulation.\n5. Agrees to comply with protocol requirements, including imaging and five year (60 month) follow-up.\n6. Considered high-risk for open surgical repair by meeting one or more of the following criteria:\n\n   1. ≥ 75 years of age\n   2. Previous median sternotomy\n   3. Documented identification of other subject-specific risk factors (e.g., medical history, active medical diagnosis) by a study investigator and an experienced open ascending and \u002F or aortic arch surgeon (e.g., cardiothoracic surgeon).\n7. Considered high-risk for surgical debranching by meeting one or more of the following criteria:\n\n   1. Prior neck surgery or radiation\n   2. Neck anatomy \u002F body habitus impeding carotid access or safe bypass tunneling\n   3. Dysphagia\n   4. Elevated risk for post-operative infection (e.g., malnutrition, uncontrolled diabetes (hemoglobin A1c \\> 9%), current treatment with immunosuppressant therapy or chemotherapy)\n   5. Reduced pulmonary function (e.g., severe chronic obstructive pulmonary disease (COPD), current or anticipated tracheostomy)\n   6. Clinical Frailty Scale score 6-7\n   7. Documented identification of other subject-specific risk factors which would pose high risk for surgical debranching (e.g., medical history, active medical diagnosis) by a study investigator\n\nExclusion Criteria:\n\nThe subject is \u002F has:\n\n1. De novo Type A dissection\n2. Requires immediate treatment.\n3. Arch vessels with dissection extending into the intended landing zones.\n4. Anticipated need for coronary or aortic valve intervention within one year post-treatment.\n5. Any aortic valve repair or replacement including transcatheter aortic valve replacement (TAVR) or coronary artery intervention within 30 days prior to treatment.\n6. Complex percutaneous coronary intervention (PCI) within 30 days prior to treatment.\n7. Open chest surgical repair within 30 days prior to treatment.\n8. Any open or interventional repair of either carotid artery within 30 days prior to treatment.\n9. Presence of Intramural Hematoma (IMH) in landing zones.\n10. Prosthetic heart valve in the aortic position that precludes safe delivery of any study device.\n11. Aortic insufficiency (AI) grade 3 or greater.\n12. Previous endovascular repair with a non-Gore device that would interfere with or result in contact with planned repair.\n13. Concomitant vascular disease, including disease associated with the great and upper extremity vessels, requiring treatment that is not planned for index endovascular procedure.\n14. Any stroke or MI within 90 days prior to treatment.\n15. Presence of protruding and \u002F or irregular thrombus and \u002F or atheroma in the ascending aorta or aortic arch or any other factor that could increase the risk of stroke based on Gore's review.\n16. Any chronic condition that is not well controlled and that is known to increase stroke risk.\n17. Known degenerative connective tissue disease (e.g., Marfan's or Ehler-Danlos Syndrome (EDS)).\n18. Participation in investigational drug or medical device study within one year of enrollment unless approved by the sponsor.\n19. Known medical, social, or psychological issues that the Investigator believes may interfere with treatment or follow-up, such as a history of drug abuse within one year of treatment.\n20. Pregnant at time of procedure or planning to become pregnant within the first 12-months of participation in the study.\n21. Active infected aorta, mycotic aneurysm.\n22. Active systemic infection (e.g., infection requiring treatment with parenteral anti-infective medication).\n23. Renal failure, defined as patients with an estimated Glomerular Filtration Rate (eGFR) \\\u003C 30 (mL\u002Fmin\u002F1.73 m2) or currently requiring dialysis.\n24. Life expectancy \\\u003C12 months.\n25. Known sensitivities or allergies to the device materials.\n26. Known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment.\n27. Body habitus or other medical condition which prevents adequate fluoroscopic and CT visualization of the aorta.\n28. Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin or a history of a hypercoagulability disorder and \u002F or state.\n29. Severe Congestive Heart Failure (CHF) (New York Heart Association (NYHA) functional class IV).\n30. Acute Coronary Syndrome (ACS) including unstable angina.","ALL","18 Years",{"count":19,"type":20},20,"ESTIMATED","INTERVENTIONAL",[23],"NA","The MBA 25-04 study is a prospective, multicenter, non-randomized, single-arm, early feasibility study designed to assess the initial safety of the MBA device through five years following the index endovascular procedure.",[26,27,28,29],"Thoracic Aortic Aneurysm","Penetrating Aortic Ulcers (PAUs)","Thoracic Aortic Dissection","Pseudoaneurysm",[31],"MBA 25-04","NOT_YET_RECRUITING","2026-05-27",{"date":35,"type":36},"2026-06-01","ACTUAL",{"date":38,"type":20},"2026-09",{"date":40,"type":20},"2034-11",{"name":42,"class":43},"W.L.Gore & Associates","INDUSTRY",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":79},"100541926","antibacterial-tactics-based-on-presepsin-level-in-thoracic-aorta-surgery-patients-100541926","NCT06336213","Antibacterial Tactics Based on Presepsin Level in Thoracic Aorta Surgery Patients","Changes in Antibacterial Therapy Based on Perioperative Dynamics of Presepsin During Reconstructive Thoracic Aorta Surgery","Inclusion Criteria:\n\nThoracic aorta aneurysm\u002Fdissection\n\nExclusion Criteria:\n\nBlood sample hemolysis","75 Years",{"count":53,"type":20},50,[23],"According to the literature, presepsin was recommended not only as an effective indicator in the diagnosis of sepsis in intensive care units, but also as a reliable prognostic marker of postoperative inflammatory processes in cardiac surgery. Previous study carried out in Petrovsky NRCS related to biomarkers in cardiac surgery and presepsin in particular showed good sensitivity in infection complications prognosis.",[57,58,26,28],"Aortic Aneurysm and Dissection","Cardiac Valve Disease",[60,61,62,63,64,65,66,67],"biomarkers","presepsin","complications","aortic arch","aorta","aortic aneurysm","ascending aorta","cardiac surgery","RECRUITING","2026-01-28",{"date":71,"type":36},"2026-01-29",{"date":73,"type":36},"2024-01-23",{"date":75,"type":20},"2027-02-15",{"name":77,"class":78},"Petrovsky National Research Centre of Surgery","OTHER",1,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":89,"phases":4,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":4},"100576519","impact-of-right-atrial-occlusion-on-tevar-outcomes-100576519","NCT06786351","Impact of Right Atrial Occlusion on TEVAR Outcomes","Impact of Right Atrial Occlusion on TEVAR Outcomes: A Prospective Cohort Study","Inclusion Criteria:\n\n* age 18 years or older\n* thoracic endovascular aortic repair\n* right atrial balloon occlusion for reduction or elimination of aortic impulse\n* endograft deployment in landing zones 0-3\n\nExclusion Criteria:\n\n* age 18 years or younger\n* non-thoracic endovascular aortic repair\n* reduction or elimination of aortic impulse using technique other than right atrial balloon occlusion\n* endograft deployment in landing zones 4 and beyond",{"count":88,"type":20},100,"OBSERVATIONAL","Though the application of thoracic endovascular aortic repair (TEVAR) for treatment of aortic pathology is expanding, there remains a gap in the literature examining how intraoperative \"reduction or elimination of aortic impulse\" (REAI) techniques, in particular the use of right atrial occlusion, may impact patient important clinical outcomes. This study aims to provide prospective data from a large cohort of TEVAR patients to explore clinical outcomes following TEVAR procedures and, specifically, whether right atrial occlusion has significant impact on clinical outcomes, as compared to other REAI techniques. The results from this study may inform future perioperative TEVAR practices and improve TEVAR patient outcomes.",[26,28,92],"Thoracic Aorta Abnormality",[94,95,96,97],"right atrial balloon occlusion","thoracic endovascular aortic repair","stent graft repair","reduction of elimination of aortic impulse","2025-06-25",{"date":100,"type":36},"2025-06-29",{"date":102,"type":20},"2025-09-01",{"date":104,"type":20},"2029-01-31",{"name":106,"class":78},"University of Calgary",{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":89,"phases":4,"briefSummary":116,"conditions":117,"keywords":118,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":133},"100536877","post-market-clinical-trial-of-the-dominus-stent-graft-100536877","NCT06270537","Post-market Clinical Trial of the Dominus® Stent-Graft","Multicenter Study Collecting Post-market Clinical Data on the Dominus® Stent-Graft for Treating Thoracic Aortic Diseases","DominusPMCF","Inclusion Criteria:\n\n1. 18 years of age or older;\n2. Patients treated with the Dominus® Stent-Graft Endoprosthesis in accordance with its Instructions for Use;\n3. Patient available for appropriate follow-up times for the study duration;\n4. Informed patient about the nature of the study, agreeing to its provisions, and signing the informed consent.\n\nExclusion Criteria:\n\n1. Patient currently participating in another clinical study of drug or medical device;\n2. Life expectancy less than 12 months.",{"count":88,"type":20},"Real-world clinical trial evidence post-market, evaluating the safety and efficacy of the Dominus® StentGraft Endoprosthesis in treating thoracic aortic diseases, following the Instructions for Use",[28],[119,120,121,122,123],"Aneurysm","Acute Aortic Syndrome","Aortic Dissection","Aortic Diseases","Cardiovascular Diseases","2024-08-21",{"date":126,"type":36},"2024-08-22",{"date":128,"type":36},"2023-10-24",{"date":130,"type":20},"2029-02-28",{"name":132,"class":43},"Braile Biomedica Ind. Com. e Repr. Ltda.",3,{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":140,"enrollmentInfo":141,"targetDuration":142,"studyType":89,"phases":4,"briefSummary":143,"conditions":144,"keywords":149,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":79},"100463055","endobarc-s-study-endovascular-branched-stent-grafts-for-aortic-arch-pathologies-in-spain-100463055","NCT05309707","ENDOBARC-S Study: \"Endovascular Branched Stent-grafts for Aortic ARCh Pathologies in Spain\"","Inclusion Criteria:\n\n* Patient is between 18 and 90 years old\n* Patient with aortic arch pathologies (aneurysm, pseudoaneurysm, dissection, penetrating ulcer, intramural hematoma), treated by branched stent-grafts (Nexus stent graft system©, Relay® Branch or Zenith arch branch graft®, with proximal landing at zone 0.\n* Patient must be available for the appropriate follow-up times for the duration of the study\n* Informed consent signed.\n\nExclusion Criteria:\n\n* Patient less than 18 years old or more than 90 years old.\n* Patient has allergies to materials necessary for endovascular repair (e.g. contrast media, anticoagulants or heparin, nitinol, polyester, gold, platinum-iridium)\n* Patient has systemic infection or suspected systemic infection\n* Patient has thrombocytopenia (platelet count \\\u003C 150000\u002Fµl)\n* Patient has untreated hyperthyroidism\n* Patient has a progressive or untreated malignancy.\n* Patient is pregnant or breastfeeding.\n* Patient has a life expectancy of less than 1 year.\n* Not informed consent signed","90 Years",{"count":88,"type":20},"5 Years","The ENDOBARC-S post-market clinical follow-up study is undertaken to evaluate the prevention of death related to aortic arch pathologies when treated by branch stent graft systems (Nexus stent-graft system®, Relay Branch® or Zenith arch branch graft®), with proximal landing at zone 0.\n\nThe secondary objective is to evaluate the safety and clinical performance of the studied devices.",[26,28,145,146,147,122,123,148],"Stent-Graft Endoleak","Stent-Graft Stenosis","Intramural Hematoma","Vascular Diseases",[150,151,152,153],"Aorta","Thoracic aortic aneurysm","Thoracic aorta dissection","Endovascular repair","2022-03-24",{"date":156,"type":36},"2022-04-04",{"date":158,"type":36},"2022-01-01",{"date":160,"type":20},"2027-12-31",{"name":162,"class":163},"Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery","NETWORK"]