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

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.

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Key information

Conditions

Cerebral Aneurysm Unruptured

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inclusion Criteria Aged 18 years or older; Patients diagnosed with unruptured intracranial aneurysms via CTA (Computed Tomographic Angiography), MRA (Magnetic Resonance Angiography), or DSA (Digital Subtraction Angiography); Patients treated with the Lattice Flow-Diverting Dense-Mesh Stent; Patients with 12-month follow-up records after treatment with the Lattice Flow-Diverting Dense-Mesh Stent; Patients whose aneurysms and parent arteries meet the indications for the Lattice Flow-Diverting Dense-Mesh Stent.

Exclusion criteria

Patients with severe respiratory, circulatory, hepatic, renal diseases, or coagulation disorders; Patients whose target aneurysms are pseudoaneurysms, or aneurysms associated with arteriovenous malformations (AVMs) or Moyamoya disease; Patients with intracranial space-occupying lesions (such as intracranial tumors, abscesses, etc.), or those undergoing radiotherapy to the head; Patients currently participating in clinical trials of other drugs or medical devices; Patients with incomplete follow-up information 12 months after treatment with the Lattice Flow-Diverting Dense-Mesh Stent; Patients who express explicit disagreement (verbally or in writing) with participating in this study; Patients with parent artery stenosis greater than 50% that requires balloon angioplasty.

Treatment and study plan

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

Primary outcomes

Raymond-Roy Classification Scale

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

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).

Sponsors and collaborators

Lead sponsor

Xinjian Yang

Other

Collaborators

Beijing Chao Yang Hospital
Chinese PLA General Hospital
Peking University International Hospital
Xuanwu Hospital, Beijing

Registry information

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2026
First posted: Sep 24, 2025
Registry last updated: Sep 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed