NCT06943729

Clinical Safety and Efficacy of Flow-diverter in the Treatment of Intracranial Aneurysms

Clinical Safety and Efficacy of Flow Diverter in the Treatment of Intracranial Aneurysms

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 523 (estimated)
• Sponsor: Huashan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To collect the safety and effectiveness data of flow-di in the treatment of intracranial aneurysms in real-world clinical practice, verify its classification of treatment strategies for aneurysms of different locations and shapes, and optimize postoperative medication regimen, provide long-term evidence-based basis for clinical treatment of intracranial aneurysms, and build a database.

Detailed description

The purpose of this study is to verify the clinical safety and effectiveness of Flow Diverters (FD) in the treatment of intracranial aneurysms. In recent years, FD, as a new type of minimally invasive interventional treatment method, has been widely used in the treatment of various types of intracranial aneurysms. FD promotes the formation of thrombosis in the aneurysm by changing the hemodynamics of the aneurysm, and promotes the repair of vascular endothelium, thereby achieving tumor occlusion. In this study, 523 patients with various types of intracranial aneurysms will be recruited in 36 centers, using a multicenter, prospective, single-arm study design. The main goal of the study was to assess the complete occlusion rate of aneurysms in the 12 months after FD treatment. Secondary goals included postoperative complications (such as cerebral infarction, intracranial thrombosis), postoperative nerve function recovery, and patients' quality of life. At the same time, a large-scale domestic FD database for the treatment of intracranial aneurysms was established. The results of the study will verify the efficacy and safety of FD through clinical imaging evaluation (mainly cerebral angiography) and long-term clinical follow-up data. At the same time, the success rate of surgery and the incidence of restenosis in the stent are analyzed to comprehensively evaluate the application prospects of FD in the treatment of intracranial aneurysms. The results of this study will provide an important evidence-based basis for further promoting the clinical application of FD, optimizing the treatment plan of aneurysms, and improving the patient's prognosis.

Conditions

• Flow Diverter

Timeline

• Start date: 2025-04-27
• Primary completion: 2026-12-30
• Completion: 2027-04-30
• First posted: 2025-04-24
• Last updated: 2025-08-29

Locations

1 site across 1 country: China