intracranial aneurysm
Conditions
Interventions
Sponsors
Xuanwu Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 80 years old (inclusive), regardless of gender; 2. Subjects with unruptured intracranial wide-necked (neck > 4mm or aspect ratio 2.0mm and <= 5.0mm; 4. Subjects clinically planned for spring coil embolization assisted by intracranial stents. If multiple aneurysms exist, only one aneurysm can be treated with the investigational device; 5. Subjects or their legal representatives can understand the purpose of the trial, voluntarily participate and complete written informed consent, and can accept and complete follow-ups on time.
Exclusion criteria
Exclusion criteria: 1. Modified Rankin Scale (mRS) score >= 3 at pre-enrollment clinical evaluation; 2. The target aneurysm has previously undergone surgical or interventional treatment; 3. Significant stenosis (>= 50%) or occlusion of the parent artery; 4. Non-target aneurysm rupture within = 180 mmHg or diastolic blood pressure continuously >= 110 mmHg); 11. Subjects with anatomical structures or lesions unsuitable for interventional treatment, including but not limited to: carotid dissection, vasculitis, aortic dissection, vascular access limitation (such as severe intracranial vessel tortuosity, severe intracranial vasospasm unresponsive to drug treatment, or other anatomical or clinical lesions causing device access obstruction); 12. Subjects with treatment contraindications, such as allergy or intolerance to contrast agents, antiplatelet/anticoagulant drugs, nickel-titanium (nitinol) or platinum; 13. Severe comorbidities or unstable conditions, such as severe heart failure, respiratory failure, or malignant tumors; 14. History of gastrointestinal bleeding within 6 months before informed consent, or history of hemorrhagic diseases (such as idiopathic thrombocytopenic purpura, etc.) or bleeding tendency, platelet count 3.0 mg/dL before enrollment; 16. Subjects who are or plan to participate in other drug or device clinical trials during the trial period; 17. Pregnant or lactating women, or those planning to become pregnant within one year; 18. Other conditions that the investigator deems unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete occlusion rate of aneurysm; | — |
Secondary
| Measure | Time frame |
|---|---|
| Technical success rate;The successful occlusion rate of aneurysms;Aneurysm retreatment rate;In - stent restenosis rate within the stent segment; | — |
Countries
China
Contacts
Public ContactHongqi Zhang
Xuanwu Hospital, Capital Medical University
Outcome results
None listed