Development Platform Construction and Application Promotion of Drug-Eluting Stents for Intracranial Aneurysm Interventional Therapy

NCT07190781 | Enrolling By Invitation DMC

• 1 other identifier: KY-2025-231-03
• Study Type: observational
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a post-marketing clinical study of the Lattice Flow-Diverting Dense-Mesh Stent. It plans to enroll 280 patients, who will be treated for unruptured intracranial aneurysms using the Lattice Flow-Diverting Dense-Mesh Stent. Patients will be followed up at 12 months after device implantation, and data including the Raymond classification of the target aneurysms, the occurrence of complications, and whether complications result in neurological deficit symptoms will be collected and assessed. Through the above indicators, the clinical safety and efficacy of the product will be evaluated.

Conditions

Cerebral Aneurysm Unruptured

Outcome Measures

Primary Outcomes (1)

• Raymond-Roy Classification Scale

  Raymond-Roy Classification Scale: Grade I: Complete occlusion; Grade II: Near-complete occlusion (with residual aneurysm neck or dog-ear sign); Grade III: Partial occlusion (with residual aneurysm sac).

  From Admission to the Hospital to 12 Months After the Completion of Surgical Treatment

Interventions

Flow-Diverting Dense-Mesh Stent DEVICE

Surface-Modified Flow-Diverting Dense-Mesh Stent for Mid-Term Follow-Up Study of Endovascular Embolization Therapy for Cerebral Aneurysms

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with unruptured intracranial aneurysms via CTA , MRA , or DSA

Sponsors & Collaborators

• Xinjian Yang: lead
• Xuanwu Hospital, Beijing: collaborator
• Beijing Chao Yang Hospital: collaborator
• Peking University International Hospital: collaborator
• Chinese PLA General Hospital: collaborator

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice Director of the Neurosurgery Department

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: September 24, 2025
• Study Start: October 24, 2022
• Primary Completion: October 24, 2022
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)