[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Endospan Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":67},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,39],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100488162","further-evaluation-of-safety-and-performance-of-the-nexus-aortic-arch-stent-graft-system-and-the-custom-made-nexus-multibranch-aortic-arch-stent-graft-system-100488162",false,"NCT05636527","Further Evaluation of Safety and Performance of the NEXUS Aortic Arch Stent Graft System and the Custom-Made NEXUS Multibranch™ Aortic Arch Stent Graft System","A Non-Randomized, Prospective or Retrospective, Open-Label, Multi-Center, Observational Clinical Study With Two Arms to Further Evaluate Safety and Performance of the NEXUS® Aortic Arch Stent Graft System and the Custom-Made NEXUS Multibranch™ Aortic Arch Stent Graft System","ARCUS","1. Male and female age ≥18 years\n2. The subject is indicated for implant of the NEXUS Aortic Arch System in accordance with the current IFU, or\n3. The subject is indicated for implant of the custom-made NEXUS DUO Aortic Arch System in accordance with the current IFU, or\n4. The subject has been already implanted, after February 2019, with the NEXUS or the NEXUS DUO according to the relevant IFU\n5. The subject is able and willing to provide informed consent to participate in the study.\n6. Subject is not currently enrolled in another investigational study or registry that would directly interfere with the current study, except if the subject is participating in a mandatory government registry, or a purely observational registry with no associated treatments. Each instance should be brought to the attention of the sponsor to determine eligibility.\n7. In the opinion of the Investigator, life expectancy exceeds one year\n8. The subject is not pregnant or planning to become pregnant.\n9. In the physician's opinion, subject's renal function is stable for the NEXUS procedure.\n10. In the opinion of the investigator, subject does not have co-morbidities or planned surgeries that will interfere with the implant of the device, e.g., major cardiac surgery or interventional procedure in the last 90 days, MI or cerebral vascular accident (CVA) in the last 90 days","ALL","18 Years",{"count":20,"type":21},70,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to collect clinical information on how safe, and how well the NEXUS Aortic Arch Stent Graft System and the Custom-Made NEXUS DUO™ Aortic Arch Stent Graft System work for the treatment of aortic aneurysms, in the standard-of-care setting.\n\nThe main question\\[s\\] it aims to answer are:\n\n* Early mortality\n* Safety outcomes throughout the study\n* Device failure throughout the study\n* Procedural and hospitalisation information Participants will be treated per institutional standard of care Follow-up information will be collected through to five years.",[25],"AAT9","RECRUITING","2025-11-26",{"date":29,"type":30},"2025-12-04","ACTUAL",{"date":32,"type":30},"2022-11-09",{"date":34,"type":21},"2030-07",{"name":36,"class":37},"Endospan Ltd.","INDUSTRY",18,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"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":48,"type":21},110,"INTERVENTIONAL",[51],"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.",[54,55,56,57],"Aortic Dissection","Aortic Aneurysm","Intramural Hematoma","Penetrating Aortic Ulcer","2025-10-16",{"date":60,"type":30},"2025-10-20",{"date":62,"type":30},"2020-10-20",{"date":64,"type":21},"2029-10",{"name":36,"class":37},32,""]