Clinical Study to Assess Deliverability, Visibility, Safety, and Performance of the IntraCranial Stent System for Endovascular Treatment of Unruptured Wide-Necked Aneurysms
- Conditions
- cerebral aneurysm
- Registration Number
- JPRN-jRCTs052230038
- Lead Sponsor
- Sakai Nobuyuki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 10
1) Patients with wide-necked unruptured cerebral aneurysms
2) Anatomical indications for stent-assisted coil embolization
3) Age between 18 and 85 at the time of consent
4) mRS score of 0-2 at the time of consent
5) Persons who have obtained written consent from the individual
1)Persons with hypersensitivity to nickel and titanium
2)Those who are unable to take antiplatelet medications
3)Previous surgical or endovascular treatment of target aneurysm
4)Those who have another cerebral aneurysm requiring treatment within 180 days after surgery
5)Those whose estimated life expectancy at the time of consent is less than 180 days, or for whom 180 days of follow-up is deemed difficult.
6)Is pregnant or wishes to become pregnant during the study period
7)Participants in other clinical trials or intervention studies
8)Persons whom the principal investigator or subinvestigator determines are not appropriate to participate in this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method