Status:
ENROLLING_BY_INVITATION
Development Platform Construction and Application Promotion of Drug-Eluting Stents for Intracranial Aneurysm Interventional Therapy
Lead Sponsor:
Xinjian Yang
Collaborating Sponsors:
Xuanwu Hospital, Beijing
Beijing Chao Yang Hospital
Conditions:
Cerebral Aneurysm Unruptured
Eligibility:
All Genders
18-80 years
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 Latti...
Eligibility Criteria
Inclusion
- 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.
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Exclusion
- 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.
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Key Trial Info
Start Date :
October 24 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT07190781
Start Date
October 24 2022
End Date
December 1 2026
Last Update
September 24 2025
Active Locations (1)
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1
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100070