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New stent shows promise in sealing brain aneurysms

NCT ID NCT06303063

Disease control Sponsor: Sinomed Neurovita Technology Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jul 14, 2026 · Updated 2 times

Summary

This study tested a new device called SINOMED IAS in 203 people with wide-necked brain aneurysms. The device is a stent placed inside the artery to block blood flow into the aneurysm, helping it heal. The main goal was to see if the aneurysm was successfully closed at 6 months after the procedure.

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

203 people

The number who actually took part.

Started

Jan 2024

Finished

Nov 2025

Lead sponsor

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

18 to 80 years

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. Age 18 years to 80 years. 2. Wide-necked (Wide-necked is defined as width ≥ 4 mm or a dome-to-neck ratio \< 2), saccular, intracranial aneurysms arising from a parent vessel with a diameter of ≥ 2.5 mm and ≤ 5mm. 3. Modified Rankin Scale (mRS) ≤ 2. 4. Subject understands the nature of the procedure, provides voluntary written informed consent prior to the treatment, and is willing to comply with specified follow-up evaluation. 5. The investigators judged the use of stent-assisted coil embolization to be appropriate for the treatment of intracranial aneurysm. Exclusion Criteria: 1. Target aneurysm is an aneurysm requiring staged procedure. 2. Target aneurysm that has been previously treated with vascular embolization or surgery. 3. Target aneurysms are fusiform aneurysms, dissecting aneurysms, pseudoaneurysms, blood blister-like aneurysms, infected aneurysms, aneurysms associated with arteriovenous malformations. 4. Hospitalized surgical treatment within 30 days before operation, or planned hospitalized surgical treatment within 6 months after surgery. 5. Acutely ruptured aneurysm within 14 days of enrollment. 6. Hunt and Hess (H\&H) scale ≥3. 7. Subject who had Moyamoya disease, arteriovenous malformations, arteriovenous fistulae, intracranial tumors, or intracranial mass lated to target aneurysms. 8. Severe stenosis or tortuosity of intracranial arteries or anatomical anomalies that make it difficult to reach the site of the lesion with device. 9. Platelet count \<50\*103/mm3 (50\*109/L) or any known coagulation deficiency, or International normalized ratio (INR)\>3.0. 10. Known hypersensitivity/allergies or contraindication to contrast media, stent components, antiplatelets, anticoagulants. 11. Life expectancy \< 1 year, and unable to complete the required follow-ups; 12. Female who was pregnant or breastfeeding, women/men planning to havve children in the next year. 13. Currently enrolled in another investigational device or drug study.

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Conditions

The condition(s) this trial relates to.

brain aneurysm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Intracranial aneurysm

Contacts and locations

Locations

  • Affiliated Drum Tower Hospital, Medical School of Nanjing University

    Nanjing, China

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, China

  • Henan Provincial People's Hospital

    Zhengzhou, China

  • Jinhua Central Hospital

    Jinhua, China

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, China

  • The First Affiliated Hospital of Harbin Medical University

    Harbin, China

  • The First Affiliated Hospital of Nanchang University

    Nanchang, China

  • The First Affiliated Hospital of Nanjing Medical University (Jiangsu Provincial People's Hospital)

    Nanjing, China

  • The First Affiliated Hospital of Wannan Medical University

    Wuhu, China

  • The First Affiliated Hospital of Xinjiang Medical University

    Xinjiang, China

  • The First Hospital of Jilin University

    Jilin City, China

  • The Second Affiliated Hospital of the Air Force Medical University (Tangdu Hospital of Fourth Military Medical University)

    Tangdu, China

  • West China Hospital of Sichuan University

    Chengdu, China

  • Zhujiang Hospital of Southern Medical University

    Zhujiang, China

More trials for these conditions

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