Compare the Safety and Effectiveness of Two Different Kinds of Stent System in Intracranial Aneurysms
NCT ID: NCT06303063
Last Updated: 2025-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
204 participants
INTERVENTIONAL
2024-01-17
2025-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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SINOMED IAS Stent System
The SINOMED IAS Stent System is intended for use with occlusive devices in the treatment of intracranial aneurysms.
SINOMED IAS Stent System
Stent-assisted coiling (SAC) of intracranial aneurysms paved the way for endovascular coiling of wide-neck aneurysms, improving rates of aneurysm obliteration and recurrence.
Neuroform Atlas Stent System
The Neuroform Atlas Stent System is intended for use with occlusive devices in the treatment of intracranial aneurysms.
Neuroform Atlas Stent System
Stent-assisted coiling (SAC) of intracranial aneurysms paved the way for endovascular coiling of wide-neck aneurysms, improving rates of aneurysm obliteration and recurrence.
Interventions
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SINOMED IAS Stent System
Stent-assisted coiling (SAC) of intracranial aneurysms paved the way for endovascular coiling of wide-neck aneurysms, improving rates of aneurysm obliteration and recurrence.
Neuroform Atlas Stent System
Stent-assisted coiling (SAC) of intracranial aneurysms paved the way for endovascular coiling of wide-neck aneurysms, improving rates of aneurysm obliteration and recurrence.
Eligibility Criteria
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Inclusion Criteria
2. Wide-necked (Wide-necked is defined as width ≥ 4 mm or a dome-to-neck ratio \< 2), saccular, intracranial aneurysms arising from a parent vessel with a diameter of ≥ 2.5 mm and ≤ 5mm.
3. Modified Rankin Scale (mRS) ≤ 2.
4. Subject understands the nature of the procedure, provides voluntary written informed consent prior to the treatment, and is willing to comply with specified follow-up evaluation.
5. The investigators judged the use of stent-assisted coil embolization to be appropriate for the treatment of intracranial aneurysm.
Exclusion Criteria
2. Target aneurysm that has been previously treated with vascular embolization or surgery.
3. Target aneurysms are fusiform aneurysms, dissecting aneurysms, pseudoaneurysms, blood blister-like aneurysms, infected aneurysms, aneurysms associated with arteriovenous malformations.
4. Hospitalized surgical treatment within 30 days before operation, or planned hospitalized surgical treatment within 6 months after surgery.
5. Acutely ruptured aneurysm within 14 days of enrollment.
6. Hunt and Hess (H\&H) scale ≥3.
7. Subject who had Moyamoya disease, arteriovenous malformations, arteriovenous fistulae, intracranial tumors, or intracranial mass lated to target aneurysms.
8. Severe stenosis or tortuosity of intracranial arteries or anatomical anomalies that make it difficult to reach the site of the lesion with device.
9. Platelet count \<50\*103/mm3 (50\*109/L) or any known coagulation deficiency, or International normalized ratio (INR)\>3.0.
10. Known hypersensitivity/allergies or contraindication to contrast media, stent components, antiplatelets, anticoagulants.
11. Life expectancy \< 1 year, and unable to complete the required follow-ups;
12. Female who was pregnant or breastfeeding, women/men planning to havve children in the next year.
13. Currently enrolled in another investigational device or drug study.
18 Years
80 Years
ALL
No
Sponsors
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Sinomed Neurovita Technology Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jianxin Yang
Role: PRINCIPAL_INVESTIGATOR
Beijing Tiantan Hospital
Locations
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Beijing Tiantan Hospital, Capital Medical University
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SNSC-IAS-202301
Identifier Type: -
Identifier Source: org_study_id
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