AAA - Abdominal Aortic AneurysmATHENANCT07754318
Aneurysm Treatment Using the Heli-FX™ EndoAnchor™ System China Study(ATHENA)
A study testing Heli-FX EndoAnchor System in people with AAA - Abdominal Aortic Aneurysm, run by Medtronic Cardiovascular at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AAA - Abdominal Aortic Aneurysm
- What is being tested?
- Heli-FX EndoAnchor System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteChina
- Study dates
- 26 Aug 2026to Aug 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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
Who cannot join
- 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;
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- 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;
- Bleeding diathesis or hypercoagulable state;
- Sealing zone thrombus, calcium or plaque > 2 mm in thickness or covering > 50% (180 degrees) of the vessel circumference;
- Irregularly shaped calcification and/or plaques at the proximal implantation sites that may interfere with proper deployment of the EndoAnchor implants;
- Mental disorders or other conditions that may impair the patient's ability to understand the nature, significance, and/or scope of the study;
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Anzhen Hospital Capital Medical University
Beijing
About this study
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
- Being tested
- Heli-FX EndoAnchor System
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heli-FX EndoAnchor SystemDevice
Subjects will be implanted with Heli-FX EndoAnchor System for AAA treatment
| Study group | Role | What they receive |
|---|---|---|
| Heli-FX | Experimental | Not described Receives: Device: Heli-FX EndoAnchor System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: within 30 days post-operation
Secondary outcomes (1)
Secondary Endpoints
- Technical success and clinical success at the time of index procedure
- All-cause mortality and aneurysm-related mortality at the time of index procedure, 30 days, 6 months, one year, and annually through 3 years.
- Type Ia endoleak at 30 days, 6 months, one year, and annually through 3 years
- Endograft migration at 6 months, one year, and annually through 3 years
- Aneurysm sac change by diameter at 6 months, one year and annually through 3 years compared to the CT(Computed Tomography) imaging at 30 days after index procedure
- Loss of endograft fabric integrity as a result of the EndoAnchor implant, rupture of the treated aneurys, conversion to open surgical repair at the time of index procedure, 30 days, 6 months, one year, and annually through 3 years
- Myocardial infarction, stroke (excluding transient ischemic attacks), renal failure and respiratory failure at 30 days, 6 months, one year, and annually through 3 years
Measured: From index-procedure to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start26 Aug 2026
- Primary completionAug 2028 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AAA - Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by Medtronic CardiovascularThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07754318
- Sponsor's protocol ID
- MDT25026AOR002
- Acronym
- ATHENA
- Status last verified
- Sep 2026
- First submitted
- 4 Aug 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No