Aneurysm Treatment Using the Heli-FX™ EndoAnchor™ System China Study(ATHENA)

Trial details

Who runs it

Medtronic Cardiovascular

Trial code

NCT07754318

Record updated

14 September 2026

Original description

To evaluate the safety and effectiveness of the Heli-FX EndoAnchor system in AAA subjects who without augmented radial fixation and/or 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.Read full original descriptionShow less

To evaluate the safety and effectiveness of the Heli-FX EndoAnchor system in AAA subjects who without augmented radial fixation and/or 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.

Inclusion: Aged 18 years or older; Male or non-pregnant female patients; women of childbearing potential must undergo a pregnancy test prior to enrollment, and the result must be negative; Willing and able to provide written informed consent; Maximum diameter of the abdominal aortic aneurysm (AAA) ≥ 4.5 cm in females or ≥ 5 cm in males; Proximal neck diameter of the AAA ranging from 19 to 32 mm; Distal fixation zone length of both iliac arteries ≥ 15 mm; Diameter of iliac artery fixation zones on both sides ranging from 8 to 25 mm; ≤ 60° infrarenal and ≤ 45°suprarenal angulation OR ≤ 75°infrarenal and ≤ 60°suprarenal angulation with proximal necks ≥ 15 mm in length; Presence of high-risk anatomical criteria, defined as meeting any one of the following criteria:; Proximal neck diameter > 28 mm and ≤ 32mm; Proximal neck length ≥ 10 mm and < 15 mm; Neck angulation ≥ 60°and ≤ 75° (angle between the long axis of the proximal neck and the long axis of the aneurysm sac); Conical neck (defined as diameter increased > 10% compared with the immediate infrarenal diameter over the first 10 mm beyond the lowest main renal artery); Investigator determined subject could benefit from this Heli-FX procedure; Patients deemed by the investigator to be suitable candidates for elective AAA repair; Patients who agree to return to the treating investigator for all scheduled follow-up visits and are able to attend hospital-based follow-up; Life expectancy > 2 years.

Exclusion: Concomitant thoracic aortic aneurysm or thoracoabdominal aortic aneurysm; History of prior AAA repair; Planned major surgery (e.g., thoracic aorta, renal, superior mesenteric artery/celiac or lower extremity revascularization, IMA reimplantation, permanent vascular access, cholecystectomy) concurrent with or within 30 days before or after the AAA repair procedure; Patients who cannot discontinue oral anticoagulation or antiplatelet therapy at the time of the study procedure; Irregularly shaped calcification and/or plaques at the proximal implantation sites that may interfere with proper deployment of the EndoAnchor implants; Participation in another investigational drug or device trial without having completed the required follow-up; Endograft planned to be used had not undergone in vitro evaluation to confirm its compatibility with the EndoAnchor implant and the aortic fixation system; Myocardial infarction within the past 3 months; Systemic infection; Infected or inflammatory AAA; Known hereditary connective tissue disorders (e.g., Marfan syndrome or Ehlers-Danlos syndrome); Renal failure requiring dialysis; Known hypersensitivity or allergy to polyester, nickel, titanium, tantalum, chromium, molybdenum, and/or cobalt; Bleeding diathesis or hypercoagulable state; Mental disorders or other conditions that may impair the patient's ability to understand the nature, significance, and/or scope of the study; Patient has a known hypersensitivity or contraindication to anticoagulants, anti-platelets, or contrast media, which is not amenable to pre-treatment; Sealing zone thrombus, calcium or plaque > 2 mm in thickness or covering > 50% (180 degrees) of the vessel circumference; Ruptured or leaking AAA; Requirement for emergency AAA repair; Patient body habitus that interferes with required imaging studies; In the opinion of the investigator, the patient has serious comorbidities that may pose an unacceptable risk for general anesthesia or endovascular intervention.

ClinicalTrials.gov NCT07754318