Researchers check safety of stent grafts used in aortic aneurysm surgery
NCT ID NCT07540507
First seen Jun 26, 2026 · Last updated Aug 07, 2026 · Updated 3 times
Summary
This study looks back at medical records of 105 people who had a minimally invasive surgery called BEVAR to treat complex aortic aneurysms. Researchers want to see if two types of stent grafts (TUVA BX and iCover) are safe and work well. No new treatments are given; the study just collects existing data from the procedure up to one year later.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- TUVA BX and iCover stent grafts (medical devices used during branched endovascular aortic repair)
- What this could lead to
- If results are positive, it could support the continued use of these stent grafts in complex aortic aneurysm repair, potentially improving outcomes.
- What could go wrong
- This is a retrospective review of past procedures, not a controlled trial. It cannot prove cause and effect, and results may not apply to all patients.
Why investors are watching
Artivion, through its Jotec GmbH unit, is collecting data on two stent grafts used in a complex aortic aneurysm repair. This retrospective study will show whether the TUVA BX and iCover devices perform safely and effectively in real-world use. For a small-cap company, a positive readout could support broader adoption of these products, while a negative one could hurt their commercial prospects.
If it works: A positive result could strengthen the case for the TUVA BX and iCover stent grafts, potentially encouraging more surgeons to use them. That could lead to higher sales of these devices for Artivion.
If it fails: If the data reveal safety or performance problems, it could damage confidence in the products and limit their use. Trials often fail to show the hoped-for results, and this study has no comparison group, so its findings may be less conclusive.
AI-written from the trial record. Speculative, and not investment advice.
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.
- Participants
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About 105 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Dec 2026
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.
Who is studied
Patients with a TAAA or AAA that require endovascular aortic repair.
- 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: * Age ≥ 18 years at the time of index procedure * Patients must have a completed treatment of TAAA or complex AAA treated with E-nside TAAA Multibranch Stent Graft System (E-nside) or E-xtra Design MultiBranch Stent Graft System (EDM) and with at least one target vessel (CT, SMA, LRA, RRA) bridged with any combination of TUVA BX or iCover. * The index procedure was performed after January 2020. * The patient is not deceased and has already completed or expects to complete the 1 year follow-up visit prior to July 2026; or the patient died. * Patients have been consented according to the local regulation. Exclusion Criteria: * Patient treated for ruptured aneurysm or who were otherwise hemodynamically unstable before the procedure. * Patients enrolled in an investigational study that could confound registry endpoints at index procedure. * Patients who developed a new onset of aortic disease (in any segment) since index procedure, potentially having an impact on the performance of the TAAA or TUVA BX /iCover, devices at the discretion of the investigator
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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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Zuyderland Medisch Centrum
RECRUITINGHeerlen, Netherlands
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Stent graft showdown: which device best tames aortic aneurysms?
- Can a tailored stent graft tame complex aortic aneurysms?
- Can tiny anchors prevent aortic aneurysm rupture?
- A simple gas flush before aortic repair might prevent strokes
- New stent grafts aim to fix aortic aneurysms without major surgery
- Aortic Stent-Graft safety under the microscope: 600-Patient european registry launches