Can tiny anchors prevent aortic aneurysm rupture?
NCT ID NCT07754318
First seen Aug 10, 2026 · Last updated Sep 15, 2026 · Updated 3 times
Summary
This trial is testing a device called the Heli-FX EndoAnchor system, which is used during minimally invasive repair of abdominal aortic aneurysms (a bulging, weakened area in the main artery). The device helps secure the stent graft in place, potentially preventing leaks or movement that could lead to serious complications. The study involves about 142 adults with aneurysms large enough to require treatment, and it will measure how well the device works and how safe it is over the first year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Heli-FX EndoAnchor system (a device that anchors stent grafts in place during aneurysm repair)
- What this could lead to
- If it works, this device could help prevent dangerous leaks or movement of stent grafts, reducing the risk of aneurysm rupture and improving long-term outcomes for patients.
- What could go wrong
- This is a device study, and success depends on technical precision. Risks include major adverse events like heart attack, stroke, kidney failure, or device-related complications within 30 days.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 142 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2026
- Expected to finish
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Aug 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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: 1. Proximal neck diameter \> 28 mm and ≤ 32mm 2. Proximal neck length ≥ 10 mm and \< 15 mm 3. Neck angulation ≥ 60°and ≤ 75° (angle between the long axis of the proximal neck and the long axis of the aneurysm sac) 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) 5. 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 Criteria: * 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; * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beijing Anzhen Hospital Capital Medical University
RECRUITINGBeijing, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Stent graft showdown: which device best tames aortic aneurysms?
- Researchers check safety of stent grafts used in aortic aneurysm surgery
- Low blood pressure after AAA surgery: hidden risks revealed
- Second shot at aneurysm fix: new pilot study launches
- One scan, two checks: could a quick abdominal CT during lung screening catch kidney cancer early?
- 10-Year watch on aneurysm repair devices begins