Laser-Cut stent grafts may offer new route for aortic aneurysm repair
NCT ID NCT06411990
First seen Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time
Summary
Researchers test a device that uses a laser to create holes in stent grafts during minimally invasive repair of aortic aneurysms. The holes allow blood to keep flowing to the kidneys and intestines when the aneurysm is close to those arteries. About 15 people who are not good candidates for open surgery will receive the device and then have checkups for up to five years to watch for complications and device problems.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A laser device system that cuts holes in stent grafts during endovascular aortic aneurysm repair
- What this could lead to
- If it works, this technique could give people with aortic aneurysms who are not candidates for open surgery a less invasive repair option that preserves blood flow to vital organs.
- What could go wrong
- This is a small, early-stage study with no control group, so it cannot prove the device works better than existing methods. Aortic repair carries risks of bleeding, stroke, kidney damage, and death, and the laser technique may fail to create durable openings or may cause leaks.
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 15 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- Expected to finish
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Jun 2033
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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: 1. Aortic aneurysm \>5.5 cm in a man or \> 5.0 cm in a woman or rapid expansion deemed at significant risk for rupture in the juxtarenal or pararenal aorta. 2. Endovascular aortic repair requiring coverage of renovisceral branches. 3. Not candidate or at high risk for open repair. For example, but not exclusively, due to renal dysfunction, previous abdominal surgery, obese body habitus, previous coronary bypass grafts or high cardiac risk, chronic obstructive pulmonary disease (COPD) or on oxygen at rest, poorly controlled diabetes, current smoking, or antiplatelet or anticoagulation use. 4. Proximal aortic landing zone in Zone 5 of the aorta or previous graft of at least 10 mm in length and diameter of between 20 and 40 mm. 5. Distance ≥ 5 mm between top of graft fabric and renovisceral branch orifice. 6. At least a 5 mm iliofemoral artery to accept the endovascular stent graft device and an axillary brachial artery of sufficient diameter to accept the laser catheter. 7. Renovisceral diameter between 4 and 13 mm at the origin. 8. At the time of case planning, the patient's anatomy appears amenable to complete exclusion of the aneurysm with laser fenestration techniques. 9. Not willing or able to travel to sites that have access to manufacturer-made investigational endovascular devices. 10. Not a candidate for currently approved endovascular options. 11. 18 years or older. 12. Patient or legally authorized representative agrees to participate in the study and provides written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization. 13. Patient is able and willing to meet all study requirements, including participating in follow up evaluations and attending required assessment visits. Exclusion Criteria: 1. Known sensitivities or allergies to the materials of construction of the devices, including Nitinol, polyester, Platinum-Iridium, stainless steel, fluoropolymer, and heparin. 2. Known hypersensitivity or contraindication to anticoagulation or contrast media that cannot be adequately medically managed. 3. Uncorrectable coagulopathy. 4. Body habitus that would inhibit radiographic visualization of the aorta or exceeds the safe capacity of equipment. 5. Concurrent participation in another research protocol for investigation of an experimental therapy. 6. Subject has been judged to be unsuitable for participation in the study by the Investigator for any reason.
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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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University of Missouri - Columbia
RECRUITINGColumbia, Missouri, 65212, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Pre-Surgery fitness and support program boost recovery from aortic aneurysm repair?
- AI may spot dangerous aortic growth before it happens
- Can a new stent keep complex aortic aneurysms safely sealed?
- Can a Stick-On AI patch replace wires for heart monitoring after surgery?
- Stent-Graft device under scrutiny for aortic aneurysm and dissection repair
- Can a 5-Minute clamp before surgery save lives?