Intracranial aneurysm
Conditions
Interventions
Small aneurysm group:blood flow guide stent system
Large aneurysm group (Test group):blood flow guide stent system
Large aneurysm group (control group):vascular reconstruction device
Sponsors
The First Affiliated Hospital of Naval Military Medical University/Huashan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Inclusion criteria for the large aneurysm group: (1) The patients voluntarily signed the informed consent; (2) Aged 18-75 years (inclusive), and the gender is not limited; (3) Patients with unruptured internal carotid artery and vertebral artery aneurysm diagnosed by CTA, MRA and DSA, the aneurysm neck >=4mm and the largest diameter of the aneurysm >=10mm were diagnosed by DSA before operation; (4) The diameter of the target lesion vessel is 2 mm-6.5 mm; (5) Good compliance, willing and able to perform treatment and follow-up observation as required. 2. Inclusion criteria for the small aneurysm group: (1) The patients voluntarily signed the informed consent; (2) Aged 18-75 years (inclusive), and the gender is not limited; (3) In patients with unruptured internal carotid artery and vertebral artery aneurysm diagnosed by CTA, MRA and DSA, the aneurysm diagnosed by DSA before surgery is a cystic or cystic type with small wide neck (neck width >= 4 mm or body-to-neck ratio < 2). Fusiform aneurysm; (4) The diameter of the target lesion vessel is 2 mm-6.5 mm; (5) Good compliance, willing and able to perform treatment and follow-up observation as required. Remarks: Small aneurysms refer to wide-necked aneurysms with a maximum diameter of less than 10 mm.
Exclusion criteria
Exclusion criteria: 1. Patients without suitable vascular access; 2. Aneurysm associated with AVM, MMD; 3. Ruptured aneurysm within 30 days; 4. Multiple aneurysms that cannot be completely covered by a single FD; 5. Recurrent aneurysms previously treated with intracranial stent implantation; 6. The investigator considers other lesions that are not suitable for stent delivery and deployment (eg, the diseased blood vessel is too tortuous, the stent cannot reach the lesion site, etc.); 7. Patients with hemorrhagic or ischemic stroke within 30 days; 8. Patients planning to undergo surgery within 30 days; 9. Preoperative mRS score > 2 points; 10. The patient's life expectancy is less than 12 months; 11. Patients who cannot receive antiplatelet aggregation or anticoagulation therapy; 12. Patients with a clear history of allergy to nickel-titanium alloys and cobalt-chromium alloys; 13. Patients who are allergic to contrast media; 14. Lactating or pregnant patients; 15. Those who have participated in clinical trials of other drugs or medical devices before being selected but did not reach the time limit of the primary research endpoint; 16. Other diseases combined with the subjects restrict their participation in the research, cannot comply with the follow-up or affect the scientific integrity of the research; 17. Other conditions in which the researcher believes that the patient is not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete occlusion rate of aneurysm 6 months after operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immediate operation success rate;Complete occlusion rate of aneurysm 12 months after operation;mRS score; | — |
Countries
China
Contacts
Public ContactLiu Jianmin, Gu Yuxiang
The First Affiliated Hospital of Naval Military Medical University/Huashan Hospital Affiliated to Fudan University
Outcome results
None listed