New brain aneurysm device shows promise in 142-Patient trial
NCT ID NCT04918420
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new medical device called the Tonbridge flow diverter to treat brain aneurysms (weak spots in blood vessels). The device is placed inside the artery to redirect blood flow away from the aneurysm, helping it heal. The trial included 142 people aged 18 to 80 with unruptured aneurysms in specific brain arteries. The main goal was to see if the aneurysm was completely blocked at 12 months after the procedure.
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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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142 people
The number who actually took part.
- Started
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Jul 2021
- Finished
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Mar 2023
- 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 to 80 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: * Age 18 to 80 years, any gender; * A single unruptured intracranial aneurysm locates in the intracranial segment of internal carotid artery (ICA) or vertebral artery (VA), which diagnosed by DSA; * The maximal diameter of the target aneurysm \< 10 mm diagnosed by DSA; * The target aneurysm with a neck ≥ 4 mm or a dome to neck ratio \< 2 diagnosed by DSA; * The target aneurysm with a parent vessel diameter of 2.0-6.5 mm; * Subject or guardian is able to understand the purpose of study, shows sufficient compliance with the study protocol and provides a signed informed consent form. Exclusion Criteria: * Diagnosed as with cerebrovascular malformations; * Intracranial hemorrhage within 30 days pre-procedure; * Modified Rankin Scale (mRS) score ≥ 3 in pre-procedure; * Platelet (PLT) \< 60×10\^9/L or known platelet dysfunction or International Normalized Ratio (INR) \> 1.5; * Heart, lung, liver and renal failure or other severe diseases (such as intracranial tumor, systemic infection, disseminated intravascular coagulation, myocardial infarction within 12 months before enrollment, history of severe psychosis, severe stenosis or occlusion of cerebral feeding artery); * Subject who is not appropriate for flow diverter delivery and deployment judged by investigators (severe stenosis of parent artery, severe tortuosity of parent artery, stent failing to reach the lesion, stent in the target lesion of parent artery, etc.); * Major surgery within 30 days before enrollment, or intending to receive surgery within 180 days after enrollment; * Allergic history of anesthetics and contrast agents, or contraindication for dual antiplatelet or/and anticoagulant therapy; * Allergic history of metals such as nickel-titanium alloy; * Life expectancy \< 12 months; * Pregnant or breastfeeding women; * Subject has participated in other drug or medical device clinical trials within 1 month before signing informed consent; * Other conditions judged by the investigators as unsuitable for enrollment.
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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.
Contacts and locations
Locations
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Changhai Hospital of Shanghai
Shanghai, China
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Henan Provincial People's Hospital
Zhengzhou, Henan, China
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Huashan Hospital Fudan University
Shanghai, China
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Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
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The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China
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Xinqiao Hospital, Army Medical University
Chongqing, China
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Zhejiang Hospital
Hangzhou, Zhejiang, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can small brain aneurysms be safely watched instead of treated?
- Can a pill tame the inflammation behind brain aneurysms?
- AI could sharpen the art of brain aneurysm repair
- Pompe disease may raise risk of brain aneurysms, new study investigates