Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Laser-Cut stent grafts may offer new route for aortic aneurysm repair

NCT ID NCT06411990

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Jun 2033

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Aortic aneurysm are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • University of Missouri - Columbia

    RECRUITING

    Columbia, Missouri, 65212, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.