Flow Diverter Stent for Intracranial Aneurysm in China

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter prospective study investigates the safety and effectiveness of a new flow diverter stent for treating intracranial wide-neck aneurysms. Eligible adults aged 22 to 80 with a planned flow diverter treatment and no recent major intracranial procedures will be enrolled after informed consent. The device aims to modify blood flow to promote aneurysm thrombosis and vessel remodeling, with outcomes assessed according to standard clinical practice for endovascular therapy. The study is conducted in Beijing, China, with multiple participating centers under the Beijing Tiantan Hospital leadership. Patient selection aligns with national indications and device use guidelines.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Signed informed consent form and agreement to comply with protocol requirements.

Age 22 to 80 years.

Diagnosed with intracranial wide-neck aneurysm and planned for treatment with a flow diverter stent.

Parent artery distal/proximal diameter compatible with available sizes and models of flow diverter stents, and treatment to be performed in accordance with the China NMPA-approved indications and instructions for use.

Exclusion Criteria:

* Need for treatment of another aneurysm in the affected territory of the target aneurysm using a different therapeutic modality during the study period.

Prior intracranial implant (e.g., coils) in the target intracranial aneurysm territory within 6 months before enrollment.

Prior surgery, including endovascular treatment, within 30 days before enrollment.

Modified Rankin Scale (mRS) score ≥ 3.

Any known contraindication to flow diverter stent treatment or antiplatelet therapy, including contraindications to dual antiplatelet therapy (DAPT).

Pre-existing stent/flow diverter placed in the parent artery of the target aneurysm location.

Investigator judges that the patient's health or the validity of study results (e.g., high risk of neurological events, conditions that may increase the chance of stroke) could be compromised by study participation.

Women who are pregnant, breastfeeding, or planning to become pregnant during the study period.

Known allergy to platinum or cobalt-chromium alloys (including major elements: platinum, cobalt, chromium, nickel, or molybdenum).

Where it's running

• Beijing Tiantan Hospital, Capital Medical University
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Hengwei Jin
• Email: jinhengwei123@163.com
• Phone: 15001189679

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Real-World Experience With the WEB Device for Intracranial Aneurysms

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• Pivotal test of the Silk Vista Baby Flow Diverter for unruptured brain aneurysms

  This study tests whether the Silk Vista Baby flow diverter can safely and effectively treat a single unruptured intracranial aneurysm in adults 22–80 years old.

  Recruiting at 6 sites Balt USA · Thousand Oaks, California and 5 other locations · NCT07225075

• Pipeline Vantage post-approval safety and outcomes for intracranial aneurysm treatment

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  Recruiting at 10 sites Medtronic Neurovascular Clinical Affairs · Jacksonville, Florida and 9 other locations · NCT06604884

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• Collecting real-life data on endovascular treatments for brain aneurysms

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  Recruiting Microvention-Terumo, Inc. · Vigo, Pontevedra · NCT06494436

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.