[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650960":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":11,"responsibleParty":26,"collaborators":11,"id":28,"slug":29,"hasResults":30,"nctId":31,"briefTitle":32,"officialTitle":32,"acronym":33,"eligibilityCriteria":34,"healthyVolunteers":30,"sex":35,"minAge":36,"maxAge":11,"enrollmentInfo":37,"targetDuration":11,"studyType":40,"phases":41,"briefSummary":43,"conditions":44,"keywords":11,"overallStatus":46,"whyStopped":11,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":11},{"fullName":5,"class":6},"Medtronic Cardiovascular","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Heli-FX","EXPERIMENTAL",null,[13],"Device: Heli-FX EndoAnchor System",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DEVICE","Heli-FX EndoAnchor System","Subjects will be implanted with Heli-FX EndoAnchor System for AAA treatment",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Fairy Liu","CONTACT","86-021-20325765","fairy.liu@medtronic.com",{"type":27,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100650960","aneurysm-treatment-using-the-heli-fx-endoanchor-system-china-studyathena-100650960",false,"NCT07754318","Aneurysm Treatment Using the Heli-FX™ EndoAnchor™ System China Study(ATHENA)","ATHENA","Inclusion Criteria:\n\n* Aged 18 years or older;\n* Male or non-pregnant female patients; women of childbearing potential must undergo a pregnancy test prior to enrollment, and the result must be negative;\n* Willing and able to provide written informed consent;\n* Maximum diameter of the abdominal aortic aneurysm (AAA) ≥ 4.5 cm in females or ≥ 5 cm in males;\n* Proximal neck diameter of the AAA ranging from 19 to 32 mm;\n* Distal fixation zone length of both iliac arteries ≥ 15 mm;\n* Diameter of iliac artery fixation zones on both sides ranging from 8 to 25 mm;\n* ≤ 60° infrarenal and ≤ 45°suprarenal angulation OR ≤ 75°infrarenal and ≤ 60°suprarenal angulation with proximal necks ≥ 15 mm in length;\n* Presence of high-risk anatomical criteria, defined as meeting any one of the following criteria:\n\n  1. Proximal neck diameter \\> 28 mm and ≤ 32mm\n  2. Proximal neck length ≥ 10 mm and \\\u003C 15 mm\n  3. Neck angulation ≥ 60°and ≤ 75° (angle between the long axis of the proximal neck and the long axis of the aneurysm sac)\n  4. Conical neck (defined as diameter increased \\> 10% compared with the immediate infrarenal diameter over the first 10 mm beyond the lowest main renal artery)\n  5. Investigator determined subject could benefit from this Heli-FX procedure\n* Patients deemed by the investigator to be suitable candidates for elective AAA repair;\n* Patients who agree to return to the treating investigator for all scheduled follow-up visits and are able to attend hospital-based follow-up;\n* Life expectancy \\> 2 years\n\nExclusion Criteria:\n\n* Myocardial infarction within the past 3 months;\n* Systemic infection;\n* Ruptured or leaking AAA;\n* Infected or inflammatory AAA;\n* Known hereditary connective tissue disorders (e.g., Marfan syndrome or Ehlers-Danlos syndrome);\n* Concomitant thoracic aortic aneurysm or thoracoabdominal aortic aneurysm;\n* Requirement for emergency AAA repair;\n* History of prior AAA repair;\n* Patient body habitus that interferes with required imaging studies;\n* In the opinion of the investigator, the patient has serious comorbidities that may pose an unacceptable risk for general anesthesia or endovascular intervention;\n* Planned major surgery (e.g., thoracic aorta, renal, superior mesenteric artery\u002Fceliac or lower extremity revascularization, IMA reimplantation, permanent vascular access, cholecystectomy) concurrent with or within 30 days before or after the AAA repair procedure;\n* Renal failure requiring dialysis;\n* Patient has a known hypersensitivity or contraindication to anticoagulants, anti-platelets, or contrast media, which is not amenable to pre-treatment;\n* Known hypersensitivity or allergy to polyester, nickel, titanium, tantalum, chromium, molybdenum, and\u002For cobalt;\n* Patients who cannot discontinue oral anticoagulation or antiplatelet therapy at the time of the study procedure;\n* Bleeding diathesis or hypercoagulable state;\n* Sealing zone thrombus, calcium or plaque \\> 2 mm in thickness or covering \\> 50% (180 degrees) of the vessel circumference;\n* Irregularly shaped calcification and\u002For plaques at the proximal implantation sites that may interfere with proper deployment of the EndoAnchor implants;\n* Mental disorders or other conditions that may impair the patient's ability to understand the nature, significance, and\u002For scope of the study;\n* Participation in another investigational drug or device trial without having completed the required follow-up.\n* Endograft planned to be used had not undergone in vitro evaluation to confirm its compatibility with the EndoAnchor implant and the aortic fixation system.","ALL","18 Years",{"count":38,"type":39},142,"ESTIMATED","INTERVENTIONAL",[42],"NA","To evaluate the safety and effectiveness of the Heli-FX EndoAnchor system in AAA subjects who without augmented radial fixation and\u002For sealing due to an endoleak or migration are at high risk for aneurysm-related complications or who are at high risk of migration or endoleak complications post-procedure, and to support product registration of Heli-FX EndoAnchor system with the National Medical Product Administration (NMPA) in China.",[45],"AAA - Abdominal Aortic Aneurysm","NOT_YET_RECRUITING","2026-08-04",{"date":49,"type":50},"2026-08-10","ACTUAL",{"date":52,"type":39},"2026-10",{"date":54,"type":39},"2030-08",{"name":5,"class":6}]