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

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07190781

Enrollment

280

Registered

2025-09-24

Start date

2022-10-24

Completion date

2026-12-31

Last updated

2025-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Aneurysm Unruptured

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.

Interventions

DEVICEFlow-Diverting Dense-Mesh Stent

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

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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. \-

Design outcomes

Primary

Measure	Time frame	Description
Raymond-Roy Classification Scale	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).

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026