Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-25 @ 3:47 AM
NCT ID:
NCT07205302
Eligibility Criteria:
Inclusion Criteria:
1. Age 18 to 80 years, any gender
2. Diagnosed as a non-saccular aneurysm in the patient's intracranial region
3. Subject or guardian is able to understand the purpose of study, shows sufficient compliance with the study protocol and provides a signed informed consent form
Exclusion Criteria:
1. Aneurysm rupture within 30 days before enrollment;
2. Diagnosis of multiple aneurysms and requiring reoperation within 12 months
3. Conditions that are not appropriate for stent delivery and deployment judged by investigators (severe stenosis of parent artery, severe tortuosity of parent artery, stent failing to reach the lesion, stent in the target lesion of parent artery, etc.);
4. Heart, lung, liver and renal failure or other severe diseases (intracranial tumor, systemic infection, disseminated intravascular coagulation, myocardial infarction within 12 months before enrollment, history of severe psychosis, severe stenosis or occlusion of cerebral feeding artery, etc.);
5. Major surgery within 30 days before enrollment，or planned to undergo surgery within 360 days after enrollment;
6. Known allergies or contraindications to anesthetics, anticoagulants, and antiplatelet drugs;
7. Known allergy to nickel-titanium alloy metal materials;
8. Life expectancy \<12 months;
9. Pregnant or breastfeeding women;
10. Subject has participated in other clinical trials within 1 month before signing informed consent;
11. Other conditions judged by the investigators as unsuitable for enrollment.
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07205302
Study Brief:
Protocol Section:
NCT07205302