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

NCT07754318 | Not Yet Recruiting FDA Device

• 1 other identifier: MDT25026AOR002
• Study Type: interventional
• Target: 142
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

AAA - Abdominal Aortic Aneurysm

Outcome Measures

Primary Outcomes (2)

• Primary Effectiveness Endpoint

  Composite treatment endpoint of Heli-FX within 12 months: * Technical success * No Type Ia endoleak * No endograft migration of proximal stent graft component * No aortic aneurysm rupture

  From procedure to 12 months after index procedure

• Primary Safety Endpoint

  Percentage of patients experiencing one or more major adverse events (MAE) within 30 days post-operation. MAEs are defined as any of the following: * All-cause mortality (ACM) * Heli-FX device-related serious adverse event (SAE) * Myocardial infarction (MI) * Stroke (excluding transient ischemic attacks) * Renal failure (excluding renal insufficiency) * Respiratory failure

  within 30 days post-operation

Secondary Outcomes (1)

• Secondary Endpoints

  From index-procedure to 3 years

Study Arms (1)

Heli-FX

EXPERIMENTAL

Device: Heli-FX EndoAnchor System

Interventions

Heli-FX EndoAnchor System DEVICE

Subjects will be implanted with Heli-FX EndoAnchor System for AAA treatment

Heli-FX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• Myocardial infarction within the past 3 months;
• Systemic infection;
• Ruptured or leaking AAA;
• Infected or inflammatory AAA;
• Known hereditary connective tissue disorders (e.g., Marfan syndrome or Ehlers-Danlos syndrome);
• Concomitant thoracic aortic aneurysm or thoracoabdominal aortic aneurysm;
• Requirement for emergency AAA repair;
• History of prior 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;
• 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;
• Renal failure requiring dialysis;
• Patient has a known hypersensitivity or contraindication to anticoagulants, anti-platelets, or contrast media, which is not amenable to pre-treatment;
• Known hypersensitivity or allergy to polyester, nickel, titanium, tantalum, chromium, molybdenum, and/or cobalt;
• Patients who cannot discontinue oral anticoagulation or antiplatelet therapy at the time of the study procedure;

Sponsors & Collaborators

• Medtronic Cardiovascular: lead

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Central Study Contacts

Fairy Liu

CONTACT

86-021-20325765; fairy.liu@medtronic.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: August 10, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2030
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share