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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aneurysm Treatment Using the Heli-FX™ EndoAnchor™ System China Study(ATHENA)
- ClinicalTrials.gov ID
- NCT07754318
- Acronym / sponsor ID
- ATHENA / MDT25026AOR002
- Conditions
- AAA - Abdominal Aortic Aneurysm
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Medtronic CardiovascularIndustry (pharma, biotech, devices)
- Study start
- 26 Aug 2026 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 10 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heli-FX | Experimental | Device: Heli-FX EndoAnchor System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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;
Key exclusion criteria (21 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heli-FX EndoAnchor SystemSubjects will be implanted with Heli-FX EndoAnchor System for AAA treatment | Device | Heli-FX |
Primary outcome
Primary Effectiveness Endpoint
Time frame: From procedure to 12 months after index procedure
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
Primary Safety Endpoint
Time frame: within 30 days post-operation
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
1 secondary outcome
Secondary Endpoints
Time frame: From index-procedure to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heli-FX EndoAnchor System in people with AAA - Abdominal Aortic Aneurysm, run by Medtronic Cardiovascular at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fairy Liu (86-021-20325765, fairy.liu@medtronic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Effectiveness Endpoint (time frame: From procedure to 12 months after index procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.