[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"intramural-hematoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:intramural-hematoma":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,59,87,114,138],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":33,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":58},"100566711","long-term-characterization-of-gore-tag-conformable-thoracic-stent-graft-with-active-control-system-performance-100566711",false,"NCT06658730","Long-term Characterization of GORE® TAG® Conformable Thoracic Stent Graft With ACTIVE CONTROL System Performance","TGR 23-02TA","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 an eligible registry device.\\*\n3. Patient is age ≥ 18 years at time of informed consent signature.\n\n   * The intent to treat a patient with a Gore product must be made prior to soliciting for possible registry participation. If pre-procedure consent is not feasible due to emergent situation, consent prior to the time of discharge for the index procedure is acceptable.\n\nExclusion Criteria:\n\n1. Patient who is, at the time of consent, unlikely to be available for standard of care (SOC) follow-up visits as defined by the site's guidelines and procedures.\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 Together Registry enrollment. Subjects cannot be enrolled in another Together Registry module protocol.\n\n   * The term \"study\" does not apply to other observational registries or quality improvement projects. Collection of Registry Device performance from interventional studies may be permissible provided device application is not investigational and there are no novel requirements that alter follow-up conduct (i.e., protocol-mandated interventions).","ALL","18 Years",{"count":19,"type":20},1500,"ESTIMATED","10 Years","OBSERVATIONAL","An observational, prospective multi-regional post-market registry collecting mid- and long-term data to assess outcomes through ten years of follow-up for subjects treated with GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System as a part of routine clinical practice. This post-market registry for the GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System (CTAG w\u002FAC) is intended to demonstrate that thoracic endovascular aortic repair (TEVAR) for lesions of the descending thoracic aorta continues to be a suitable treatment option for appropriately selected patients.",[25,26,27,28,29,30,31,32],"Vascular Disease","Dissection","Dissection Aortic Aneurysm","Dissection of Aorta","Aneurysm Thoracic","Aneurysm Dissecting","Transection Aorta","Intramural Hematoma",[34,35,36,37,38,39,40,41,42,43,14,44,45],"Endovascular","CTAG","Post-market Registry","Observational","Multi-regional","Real world data","Together Registry","Gore Together Registry","Gore Together Aortic Registry","Conformable Thoracic Stent Graft","TGR23-02TA","GORE TAG","RECRUITING","2026-06-19",{"date":49,"type":50},"2026-06-23","ACTUAL",{"date":52,"type":50},"2025-06-19",{"date":54,"type":20},"2038-08",{"name":56,"class":57},"W.L.Gore & Associates","INDUSTRY",36,{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":67,"targetDuration":4,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":86},"100398727","nexus-aortic-arch-clinical-study-to-evaluate-safety-and-effectiveness-100398727","NCT04471909","NEXUS Aortic Arch Clinical Study to Evaluate Safety and Effectiveness","A Multi-arm, Multi-Center, Non-Randomized, Prospective, Clinical Study to Evaluate the Safety and Effectiveness of the NEXUS Aortic Arch Stent Graft System in Treating Thoracic Aortic Lesions Involving the Aortic Arch","TRIOMPHE","Inclusion Criteria:\n\n1. Male and female age ≥ 18.\n2. Proximal\u002Fascending native or previously implanted surgical graft landing zone of appropriate length\n3. Proximal\u002Fascending native or previously implanted surgical graft landing zone of appropriate diameter\n4. Distal\u002Fdescending native landing zone of appropriate length\n5. Distal\u002Fdescending native landing zone of appropriate diameter\n6. Brachiocephalic trunk native landing zone of appropriate length\n7. Brachiocephalic trunk native landing zone of appropriate diameter\n8. Appropriate take off angle between the Brachiocephalic Artery and the Aortic Arch perpendicular\n9. Appropriate aortic arch perpendicular diameter\n10. Chronic dissection with at least one of the following conditions:\n\n    1. An aortic aneurysm with a maximum diameter ≥ 55 mm\n    2. Rapidly expanding false lumen (growth of \\> 0.5 cm\u002F6 months)\n    3. Compressed true lumen associated with end organ malperfusion\n    4. Symptomatic\n11. Aneurysm with at least one of the following conditions:\n\n    1. Dilatation of the aortic arch larger than 5 cm in diameter for subject with fusiform aneurysm\n    2. Dilatation of the aortic arch is 1.5 times the normal diameter for subjects ascending or descending\n    3. Dilation of the aortic arch larger than 2.5 cm for subject with saccular aneurysm\n    4. Symptomatic aneurysm of the aortic arch\n    5. Aortic diameter growth rate \\> 5mm per 6 months\n    6. Postoperative pseudoaneurysm expanding from anastomotic suture lines\n12. Penetrating aortic ulcer with at least one of the following:\n\n    1. Symptomatic\n    2. Ulcer demonstrates expansion\n13. Intramural hematoma with at least one of the following:\n\n    1. Symptomatic (persistent pain)\n    2. Transverse or longitudinal expansion on serial imaging\n14. In the event of a lesion in the ascending aortic, the proximal\u002Fascending native or previously implanted surgical graft the landing zone must be appropriate\n15. Femoral \u002F iliac artery diameter as documented by CTA or MRA that allows endovascular access to the diseased site with a 20 Fr. delivery catheter.\n16. Access vessels morphology suitable for endovascular repair in terms of tortuosity, calcification and angulation, documented by CTA\u002FMRA.\n17. Brachial\u002FAxial Artery diameter that allows endovascular access suitable for 7 Fr.\n18. Subject is considered an appropriate candidate for an elective surgery.\n19. Subject is considered to be at high risk for open repair, as determined by the investigator.\n20. Access vessels, iliac\u002Ffemoral \\& brachial\u002Faxillary compatible with vascular access techniques (femoral cutdown or percutaneous), devices, and \u002For accessories.\n21. Subject is willing and able to comply with procedures specified in the protocol and is able to return for follow-up visits as specified by the protocol.\n\nExclusion Criteria:\n\n1. Acute dissection\n2. Lesions that can be safely treated with TEVAR landing in zone 2 (with or w\u002Fo LSA vascularization)\n3. Required emergent treatment, e.g., trauma, rupture\n4. Acute vascular injury of the aorta due to trauma\n5. Aortic rupture or unstable aneurysm\n6. Received a previous stent or stent graft in the treated area (including planned landing area)\n7. Required surgical or endovascular treatment of an infra-renal aneurysm at time of implantation\n8. Planned major surgical or interventional procedure at time of screening, to be performed after the NEXUS™ implantation.\n9. Any major surgical or interventional procedure 6 weeks before the NEXUS™ implantation, exclusive of planned procedures that are needed for the safe and effective placement of the stent graft (e.g. supra-aortic bypass).\n10. Subject has had a myocardial infarction (MI) or cerebral vascular accident (CVA) within 90 days prior to the planned implantation\n11. Subjects with severe aortic valvular insufficiency as determined by echocardiography\n12. Mechanical valve that preclude safe delivery of NEXUS™\n13. Known Connective tissue disease (e.g., Marfan's or Ehler's-Danlos syndromes)\n14. Subject has an active systemic infection at the time of the procedure documented by pain, fever, drainage, positive culture\n15. Pregnant\n16. Life expectancy of less than 2 years\n17. Unsuitable vascular anatomy\n18. Subject who have a previously implanted surgical wrap of the ascending aorta\n19. Any medical condition that, according to the investigator's decision, might expose the subject to increased risk by the investigational device or procedure.\n20. An aneurysm that is mycotic, inflammatory or suspected to be infected.\n21. Subject with hostile groins\u002Faxilla (scarring, obesity, or previous failed puncture) unless conduit are used.\n22. Subjects with severe atherosclerosis, severe calcification or extensive intraluminal thrombus of the aorta or in the brachiocephalic trunk\n23. Subject is suffering from unstable angina or NYHA classification III and IV.\n24. Subject has a known hypersensitivity or contraindication to anticoagulants, antiplatelets, or contrast media, which is not amenable to pre-treatment.\n25. Subject with a contraindication to undergo angiography\n26. Subject with known sensitivities or allergies to the device materials (including Nitinol \\[NiTi\\], polyester fabric \\[PET\\], tantalum \\[TA\\])\n27. Clinical conditions that severely inhibit x-ray visualization of the Aorta.\n28. Subject has history of bleeding diathesis or coagulopathy that may limit the use of dual antiplatelet or anticoagulant therapy by the decision of the investigator\n29. Acute renal failure; chronic renal failure (excluding dialysis); Creatinine \\> 2.00 mg\u002Fdl\n30. Any other medical, social, or psychological issues that in the opinion of the investigator preclude them from receiving this treatment, or the procedures and evaluations pre- and post- treatment.\n31. Active participation in another clinical study that has not completed primary endpoint(s) evaluation or that clinically interferes with the endpoints in this study, or subject is planning to participate in such study prior to the completion of this study.",{"count":68,"type":20},110,"INTERVENTIONAL",[71],"NA","Prospective, non-randomized, multi-center clinical investigation of the NEXUS™ Aortic Arch Stent Graft System (NEXUSTM) for the treatment of thoracic aortic lesions involving the aortic arch with a proximal landing zone, native or previously implanted surgical graft, in the ascending aorta and with a brachiocephalic trunk native landing zone.",[74,75,32,76],"Aortic Dissection","Aortic Aneurysm","Penetrating Aortic Ulcer","2025-10-16",{"date":79,"type":50},"2025-10-20",{"date":81,"type":50},"2020-10-20",{"date":83,"type":20},"2029-10",{"name":85,"class":57},"Endospan Ltd.",32,{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":69,"phases":96,"briefSummary":97,"conditions":98,"keywords":101,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":113},"100224613","feasibility-of-endovascular-repair-of-ascending-aortic-pathologies-100224613","NCT02201589","Feasibility of Endovascular Repair Of Ascending Aortic Pathologies","Proposed Single Center Investigational Device Exemption: Feasibility of Endovascular Repair Of Ascending Aortic Pathologies","Inclusion Criteria:\n\n* Patient must have a Type A thoracic aortic dissection, retrograde Type A thoracic aortic dissection, intramural hematoma, penetrating ulcer or pseudoaneurysm of the ascending thoracic aorta affecting the area between the Sinus of Valsalva and the innominate artery orifice (with no involvement of the aortic valve) and be considered candidates for endovascular repair;\n* Patient must also have at least one cm proximal and distal landing zones in the ascending aorta between 28-44 mm in diameter;\n* The patient must be deemed high-risk surgical candidate according to the following established criteria: ASA (American Society of Anesthesiologists) class IV.\n\nExclusion Criteria:\n\n* Pregnant or pediatric patients (younger than 21 years of age);\n* Patients who have a condition that threatens to infect the stent graft\u002Faortic valve prosthesis;\n* Patients with allergies to the stent graft material;\n* Patients or their legally authorized representatives who do not sign the informed consent;\n* Patients with expected survival less than one year.",{"count":95,"type":20},20,[71],"The purpose of this study is to investigate the outcome of patients with pathologies of the ascending thoracic aorta (diseases in the great blood vessel or artery that leads away from the heart) including type A aortic dissection, retrograde type A aortic dissection, intramural hematoma, penetrating ulcer or pseudoaneurysm who are suitable for endovascular (within the vessel) repair with the Medtronic Valiant PS-IDE (Physician Sponsored-Investigational Device Exemption) Stent Graft. Type A aortic dissection is a condition where blood passes through the inner lining or between the layers of the blood vessel from a tear in the aortic wall (dissection) in the ascending aorta; a retrograde Type A aortic dissection is a condition where the dissection or tear in the ascending aorta starts from the descending aorta; an intramural hematoma is a collection of clotted blood within the aortic wall; a penetrating ulcer has a plaque or clot within the wall and a pseudoaneurysm is a false aneurysm . If left untreated in any of these conditions, the aorta can enlarge and rupture causing injury or death. The plan for these patients is to repair the ascending thoracic aorta using the Medtronic Valiant PS-IDE Stent Graft with the Captivia Delivery System. The Valiant Captivia has been evaluated worldwide and used extensively in patients with type B (descending) thoracic aortic dissection. Since the dissections in the ascending aortas mirror that of the descending aorta, it is expected that this stent graft will deliver similar performance and endurance in patients with type A aortic dissection. The investigators expect to reroute the blood to the true lumen (the inner space within the blood vessel) by covering the proximal (nearest to the heart) tear with the stent graft. The stent graft is a stent frame made from Nitinol wire and covered with an expandable material made of a polyester material. This new study will determine how well the device works to treat dissections, intramural hematomas, penetrating ulcers and pseudoaneurysms in the ascending thoracic aorta.",[74,32,99,100],"Penetrating Ulcer","Pseudoaneurysm",[102],"Lesions in the ascending thoracic aorta","2025-05-02",{"date":105,"type":50},"2025-05-06",{"date":107,"type":50},"2013-11",{"date":109,"type":20},"2033-12",{"name":111,"class":112},"Rodney A. White, MD","OTHER",3,{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":121,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":69,"phases":124,"briefSummary":125,"conditions":126,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":137},"100506424","cratos---evaluation-of-cratos-branch-stent-graft-system-in-treatment-of-descending-aorta-lesions-100506424","NCT05874206","CRATOS - Evaluation of Cratos™ Branch Stent Graft System in Treatment of Descending Aorta Lesions","Evaluation of Cratos™ Branch Stent Graft System in Treatment of Descending Aorta Lesions","Inclusion Criteria:\n\n1. Presence of thoracic aortic pathology (Dissection, including IMH and ULP; and PAU) deemed to warrant surgical repair which requires proximal graft placement in Zone 2\n2. Age ≥18 years at time of informed consent signature\n3. Informed Consent Form (ICF) is signed by Subject or legal representative\n4. Must have appropriate proximal aortic landing zone, defined as:\n\n   * Landing zone inner diameters between 23-41 mm\n   * The length of landing zone ≥15mm\n   * Landing without heavily calcified or heavily thrombosed\n   * Dissection Patients: Primary entry tear must be distal to LSA, and proximal extent of the proximal landing zone must not be dissected.\n   * For patients with prior replacement of the ascending aorta and\u002For aortic arch by a surgical graft, there must be at least 2 cm of landing zone proximal to the most distal anastomosis site.\n5. Must have appropriate LSA landing zone, defined as:\n\n   * Inner diameters of LSA 5-14 mm\n   * Minimum length of Left subclavian artery is 25 mm\n   * Target branch vessel landing zone must be in native aorta that cannot be severely tortuous , aneurysmal, dissected, heavily calcified, or heavily thrombosed.\n6. Must have appropriate distal aortic landing zone, defined as:\n\n   * Aortic inner diameters between 18-44 mm\n   * Landing zone cannot be heavily calcified, or heavily thrombosed.\n   * For isolated PAU, outer curvature length must be ≥ 2cm proximal to the celiac artery\n   * Landing zone in native aorta\n\nExclusion Criteria:\n\n1. Concomitant disease of the ascending aorta or aneurysm of the abdominal aorta requiring repair\n2. Previous endovascular repair of the ascending aorta\n3. Infected aorta, active systemic infection\n4. Surgery within 30 days prior to enrolment with the exception of placement of vascular conduit for access .\n5. Life expectancy \\\u003C1 years\n6. Myocardial infarction within 6 weeks prior to treatment\n7. Stroke within 6 weeks prior to treatment.\n8. Pregnant or breastfeeding female\n9. Patient has an active systemic infection (e.g., infection requiring treatment with parenteral anti-infective medication) that may place the patient at increased risk of endovascular infection.\n10. Degenerative connective tissue disease, e.g., Marfan's or Ehlers-Danlos Syndrome\n11. Participation in another drug or medical device study within one year of study enrolment\n12. Known history of drug abuse within one year of treatment\n13. Tortuous or stenotic iliac and\u002For femoral arteries preventing introducer sheath insertion and the inability to use a conduit for vascular access\n14. Planned coverage of celiac artery\n15. Allergic to contrast agents, anaesthetics and delivery materials\n16. Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin\n17. Patient with a history of a hypercoagulability disorder and\u002For is currently in a hypercoagulability state\n18. Persistent refractory shock (systolic blood pressure \\\u003C90 mm Hg)\n19. Renal failure defined as patients with an estimated Glomerular Filtration Rate (eGFR) \\\u003C30 (ml\u002Fmin\u002F1.73 m2) or currently requiring dialysis\n20. Contraindications to antiplatelet drugs and anticoagulants\n21. Investigator judged that not suitable for interventional treatment.",true,{"count":123,"type":20},130,[71],"The goal of this prospective, interventional, multicentre, single-arm performance objective study is to evaluate efficacy and safety of Cratos™ Branch Stent Graft System in treatment of lesions (dissection, IMH and PAU in descending aorta. The main question\\[s\\] it aims to answer are:\n\n* 30-day all-cause Mortality rate\n* Composite of the following events from the time of enrolment through 12-month:\n\n  * Device Technical Success\n  * Absence of: Aortic rupture, Lesion-related mortality, Disabling Stroke, Permanent paraplegia, Permanent paraparesis, New onset renal failure requiring permanent dialysis, Additional unanticipated post-procedural surgical or interventional procedure related to the device, procedure, or withdrawal of the device system\n\nParticipants will come for hospital office visits 1, 6, 12, 24-, 36-, 48- and 60-months post-procedure for the following, but not limited to assessments:\n\n* Physical examination\n* Modified Rankin scale\n* Tarlov scoring scale\n* CTA",[127,32,76],"Aortic Dissection Type B","2025-02-24",{"date":130,"type":50},"2025-02-26",{"date":132,"type":50},"2024-03-08",{"date":134,"type":20},"2031-12",{"name":136,"class":57},"Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd",1,{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":144,"enrollmentInfo":145,"targetDuration":147,"studyType":22,"phases":4,"briefSummary":148,"conditions":149,"keywords":157,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":137},"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":146,"type":20},100,"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.",[150,151,152,153,32,154,155,156],"Thoracic Aortic Aneurysm","Thoracic Aortic Dissection","Stent-Graft Endoleak","Stent-Graft Stenosis","Aortic Diseases","Cardiovascular Diseases","Vascular Diseases",[158,159,160,161],"Aorta","Thoracic aortic aneurysm","Thoracic aorta dissection","Endovascular repair","2022-03-24",{"date":164,"type":50},"2022-04-04",{"date":166,"type":50},"2022-01-01",{"date":168,"type":20},"2027-12-31",{"name":170,"class":171},"Vascular Investigation Network Spanish Society for Angiology and Vascular Surgery","NETWORK"]