Intracranial aneurysm
Conditions
Interventions
Experimental group:The study participants were enrolled 24 hours after implantation of blood flow guided dense mesh stents and took a single antiplatelet drug upon enrollment.
Sponsors
Fudan University Affiliated Huashan Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age range of 18-75 years old (including 18 and 75 years old), gender is not limited; 2. An unruptured wide neck (neck >= 4mm or tumor/neck ratio<2) intracranial aneurysm with no evidence of rupture in recent 6 months of intracranial imaging examinations; 3. The imaging measurement diameter of the tumor carrying artery is 1.75mm-6.0mm; 4. Plan to use AUCURA blood flow guided dense mesh stent implantation for treatment; 5. Voluntarily participate under the free will of the research participants themselves or their guardians, and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. History of acute ischemic stroke; 2. Patients with recurrent aneurysms; 3 Screening for intracranial hemorrhage caused by any reason within the first 3 months, such as subarachnoid hemorrhage, intraventricular hemorrhage, etc; 4. Screening for surgical treatments other than endovascular therapy, such as craniotomy, micro clipping, etc., in the previous 3 months or currently undergoing endovascular therapy; 5. Patients diagnosed with over 50% stenosis of the tumor carrying artery or other main arteries with over 50% stenosis requiring intensified antiplatelet therapy; 6. Contraindications related to angiography, such as allergy to iodinated contrast agents, sepsis, etc; 7. I was regularly taking dual antiplatelet drugs 7 days before screening; 8. Individuals allergic to blood flow guided dense mesh stents, such as ethylene tetrafluoroethylene copolymers and cobalt chromium nickel platinum alloys; 9. Patients with poor results of dense mesh stent implantation due to surgical procedures (such as poor adhesion, stent deformation, etc.); 10. Those who are unable to take antiplatelet drugs according to the research protocol; 11. Study participants with platelet counts3.0; 12. Severe renal insufficiency (creatinine exceeding 1.5 times the upper limit of normal) or liver insufficiency (ALT or AST exceeding twice the upper limit of normal); 13. Severe heart failure (New York College of Cardiology Class III and IV) or severe arrhythmia (such as persistent ventricular tachycardia, ventricular fibrillation, persistent or paroxysmal atrial fibrillation, atrial flutter, frequent premature ventricular contractions, second and third degree atrioventricular block, etc.); 14. Patients with arteriovenous malformations, vesicular aneurysms, or aneurysms involving the basilar artery; 15. Pregnant or lactating women and those planning to conceive; 16. Patients who have participated in clinical studies of other drugs or medical devices within 30 days prior to participating in this study; 17. The researchers believe that patients who are not suitable to participate in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of new infarcted lesions detected by DWI at 3 months postoperatively;Incidence of complications within 30 days after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of any stroke or death within 30 days after surgery, as well as ischemic stroke events in the target vascular area from 31 days to 3 and 6 months;The incidence of thromboembolic complications at 1, 3, and 6 months after surgery;The incidence of cerebral hemorrhage at 1, 3, and 6 months after surgery;The incidence of other bleeding (including peripheral bleeding, gastrointestinal bleeding, subcutaneous bleeding, gingival bleeding, etc.) in the first, third, and sixth months after surgery;The incidence of severe stroke on the same side of the target vessel (defined as a NIHSS score increase of = 4 points after the event, including hemorrhagic stroke and ischemic stroke) or neurological death at 1, 3, and 6 months postoperatively;Complete occlusion rate of aneurysm in the third month after surgery (Raymond I grade);Successful occlusion rate of aneurysm in the third month after surgery (Raymond I+II grade);The proportion of patients with tumor carrying artery stenosis <= 50% in the third month after surgery and who did not receive replacement therapy after surgery;Changes in Modified Rankin Scale (mRS Score) from Baseline at 1, 3, and 6 Months After Surgery;Total stroke incidence at 1, 3, and 6 months after surgery;Postoperative all-cause mortality rates at 1, 3, and 6 months;Incidence of adverse events and serious adverse events; | — |
Countries
China
Contacts
Public ContactYuxiang Gu
Fudan University Affiliated Huashan Hospital
Outcome results
None listed