Brain aneurysm showdown: which coated stent causes fewer strokes?
NCT ID NCT07674004
First seen Jun 29, 2026 · Last updated Jul 02, 2026 · Updated 3 times
Summary
This trial compares two types of surface-modified flow diverters—special stents used to treat unruptured brain aneurysms. The goal is to see which device causes fewer small brain injuries (seen on MRI) and fewer stroke-like symptoms after the procedure. About 196 people with unruptured aneurysms will be randomly assigned to receive one of the two devices, and their outcomes will be tracked for six months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Lattice Flow Diverter (LFD) and Pipeline Flex Embolization Device with Shield Technology (PED Shield)
- What this could lead to
- If one device proves safer, it could become the preferred option for treating unruptured brain aneurysms, lowering the chance of stroke after the procedure.
- What could go wrong
- This is a relatively small trial (196 people) comparing two devices already in use, so the difference may be small or not statistically significant. Risks include stroke, bleeding, or device-related complications.
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 196 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Sep 2027
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 to 75 years
- 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. Patients were diagnosed with unruptured intracranial aneurysms, and the lesions were evaluated to be suitable for endovascular treatment with flow diverter devices (PED Shield/Lattice). 2. During the study period, only one target aneurysm per patient was treated, with the exception of segmental lesions, in which multiple aneurysms located within the same arterial segment were treated with a single or overlapping study devices. 3. The target aneurysm was treated solely with flow diverter (FD) implantation in the current study. 4. The age of enrolled patients ranged from 18 to 75 years old. 5. Patients were capable of understanding the study-related informed consent information and provided written informed consent for the use of their clinical data for research purposes. Exclusion Criteria: 1. Patients with a prior history of endovascular treatment for the target aneurysm. 2. Patients in the acute stage of cerebrovascular diseases (acute cerebral infarction or intracerebral hemorrhage with an onset time of ≤ 2 weeks). 3. Patients complicated with other cerebrovascular disorders, including moyamoya disease, cerebrovascular malformations, and arteriovenous fistula. 4. Patients with atherosclerotic changes in the parent artery of the target aneurysm that necessitated additional intraoperative endovascular interventions (e.g., balloon angioplasty or conventional stent implantation). 5. Patients with a preoperative modified Rankin Scale (mRS) score greater than 2. 6. Patients with any absolute contraindications to device treatment as specified in the Instructions for Use (IFU). 7. Patients enrolled in other clinical trials that may interfere with the primary or secondary endpoints of the present study. 8. Patients with comorbidities that may interfere with neurological function evaluation, affect survival status, or impair the ability to complete follow-up visits. 9. Pregnant or lactating female patients.
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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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Henan Provincial People's Hospital
RECRUITINGZhengzhou, Henan, 450000, China
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Other studies related to the condition(s) this trial covers.
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