Flow-diverter treatment for brain aneurysms: safety and effectiveness
Clinical Safety and Efficacy of Flow Diverter in the Treatment of Intracranial Aneurysms
This project will try a flow-diverter device to see if it safely closes brain aneurysms in adults.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 523 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Huashan Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06943729 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-arm, multicenter study enrolling about 523 adults with various intracranial aneurysm types to collect real-world safety and effectiveness data on flow-diverter devices. Patients receive flow-diverter treatment and are followed with clinical visits and imaging, mainly cerebral angiography, with the primary outcome of complete aneurysm occlusion at 12 months. Secondary outcomes include postoperative complications (for example cerebral infarction or intracranial thrombosis), neurological function recovery, quality of life, surgical success rate, and stent restenosis. The study will also establish a large domestic database to inform treatment strategies, device use for different aneurysm locations and shapes, and optimal postoperative medication regimens.
Who should consider this trial
Good fit: Adults aged 18–80 with an unruptured intracranial aneurysm (including wide-necked, saccular, fusiform, recurrent, or dissecting types) with a parent vessel diameter of 2.0–6.0 mm in specified cerebral segments, who can consent and attend follow-up at a participating center, are ideal candidates.
Not a fit: Patients with acute ruptured or AVM-related aneurysms, recent stroke within 30 days, severe vessel tortuosity or stenosis preventing device delivery, preoperative mRS >2, or limited life expectancy are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, the device could offer a less invasive option that more effectively closes certain aneurysms and reduces long-term complications for selected patients.
How similar studies have performed: Similar flow-diverter devices have been widely used and prior studies report high occlusion rates for many aneurysm types, though they carry known risks such as thromboembolic events and require careful patient selection.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1)18 years ≤80 years; 2) intracranial aneurysm diagnosed by CTA, MRA or DSA (Including wide-necked aneurysms (neck width ≥4mm or Dome/neck ratio \<2), saccular, fusiform aneurysms, recurrent saccular aneurysms and dissecting aneurysms, and the diameter of the parent vessel ≥ 2.0 mm and ≤ 6.0 mm; the location includes: anterior circulation C3 segment and above of internal carotid artery, distal artery of Willis circle, posterior circulation V4 segment of vertebral artery and basilar artery and its main branches; 3) Voluntary participation in this study and signing of the Informed Consent Form (ICF). Exclusion Criteria: 1)AVM related aneurysm; 2) Acute ruptured aneurysm; 3) Severe stenosis or tortuosity of intracranial artery, or anatomical abnormality, which makes it difficult for the device to reach the lesion ; 4) Patients with hemorrhagic or ischemic stroke within 30 days; 5) Modified Rankin Score (mRS)\>2 points before operation; 6) Patients with life expectancy less than 12 months; 7) Patients with definite history of allergy to cobalt-chromium alloy and platinum-tungsten alloy materials; Allergy to contrast media; 8) antiplatelet (PLT)\<100×10\^ 9 /L or/and anticoagulation contraindicated; 9) pregnant or lactating women; 10) other study participants who were assessed by the investigator as unsuitable for participation in the study. Intraoperative exclusion criteria: 1) acute rupture and hemorrhage of aneurysm during operation; 2) failure of FD implantation; 3) thrombosis in stent; 4) stent mal-apposition.
Where this trial is running
Shanghai, Shanghai Municipality
- Huashan hospital — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Gao Chao, PhD
- Email: gc_huashanneuro@sina.com
- Phone: 18916960799
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.