Last updated: March 29, 2024
Sponsor: Sinomed Neurovita Technology Inc.
Overall Status: Active - Recruiting
Phase
N/A
Condition
Aneurysm
Treatment
SINOMED IAS Stent System
Neuroform Atlas Stent System
Intracranial stent system
Clinical Study ID
NCT06303063
SNSC-IAS-202301
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age 18 years to 80 years.
- 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 ≥ 2.5mm and ≤ 5mm.
- Modified Rankin Scale (mRS) ≤ 2.
- Subject understands the nature of the procedure, provides voluntary written informedconsent prior to the treatment, and is willing to comply with specified follow-upevaluation.
- The investigators judged the use of stent-assisted coil embolization to be appropriatefor the treatment of intracranial aneurysm.
Exclusion
Exclusion Criteria:
- Target aneurysm is an aneurysm requiring staged procedure.
- Target aneurysm that has been previously treated with vascular embolization orsurgery.
- Target aneurysms are fusiform aneurysms, dissecting aneurysms, pseudoaneurysms, bloodblister-like aneurysms, infected aneurysms, aneurysms associated with arteriovenousmalformations.
- Hospitalized surgical treatment within 30 days before operation, or plannedhospitalized surgical treatment within 6 months after surgery.
- Acutely ruptured aneurysm within 14 days of enrollment.
- Hunt and Hess (H&H) scale ≥3.
- Subject who had Moyamoya disease, arteriovenous malformations, arteriovenous fistulae,intracranial tumors, or intracranial mass lated to target aneurysms.
- Severe stenosis or tortuosity of intracranial arteries or anatomical anomalies thatmake it difficult to reach the site of the lesion with device.
- Platelet count <50103/mm3 (50109/L) or any known coagulation deficiency, orInternational normalized ratio (INR)>3.0.
- Known hypersensitivity/allergies or contraindication to contrast media, stentcomponents, antiplatelets, anticoagulants.
- Life expectancy < 1 year, and unable to complete the required follow-ups;
- Female who was pregnant or breastfeeding, women/men planning to havve children in thenext year.
- Currently enrolled in another investigational device or drug study.
Study Design
Total Participants: 204
Treatment Group(s): 3
Primary Treatment: SINOMED IAS Stent System
Phase:
Study Start date:
January 17, 2024
Estimated Completion Date:
December 30, 2025
Study Description
Connect with a study center
Beijing Tiantan Hospital, Capital Medical University
Beijing,
ChinaActive - Recruiting
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