Intracranial aneurysm
Conditions
Interventions
Treatment group:The anticoagulant blood flow guided close-mesh stent system produced by Chengdu Neurotrans Medical Equipment Co., Ltd. was used for treatment
Sponsors
Changhai Hospital of Shanghai
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Unruptured cystic or fusiform aneurysms of the carotid artery (distal to the rock tip) and vertebral artery, with vessel diameter =1.5mm and =6.5mm; (2) Age range is 18-75 years old, gender is not limited; (3) Target aneurysms can be treated with interventional treatment in a one-time operation; (4) The subject or his legal guardian is able to understand the purpose of the study, demonstrate sufficient compliance with the study protocol, and sign informed consent
Exclusion criteria
Exclusion criteria: (1) Patients with recurrent target aneurysms after previous stent therapy (not limited to staging aneurysm therapy); (2) History of stroke within 30 days; (3) Patients who plan to undergo surgery within 1 month after surgery; (4) Target aneurysms were blood vesicular aneurysms, pseudoaneurysms or arteriovenous malformations, moyamoya disease related aneurysms, multiple aneurysms requiring simultaneous treatment, ruptured aneurysms; (5) Lesions considered unsuitable for stent delivery and deployment by researchers (such as severe tortuosity of the carrier artery, severe stenosis of the carrier artery, severe cerebrovascular spasm, and failure of the stent to reach the target lesion site); (6) Patients who are unable to receive antiplatelet aggregation and/or anticoagulation therapy; (7) Patients who are known to be allergic to Nitinol and platinum-iridium alloys; (8) suffering from a disease that makes treatment and evaluation difficult (such as cancer, infection, severe metabolic disease, inability to express wishes due to psychiatric disorders (such as aphasia, coma), mental illness, etc.); (9) Subjects with intracranial space-occupying diseases (such as intracranial tumors, abscesses, etc.), or who are undergoing radiation therapy in the skull area; (10) Patients with liver dysfunction before surgery (patients with active liver disease or ALT> 3 times the upper limit of normal); (11) Preoperative patients with abnormal renal function (serum creatinine =2.5mg/d); (12) Patients with known coagulation dysfunction or bleeding tendency (platelet 3); (13) Poor clinical status, mRS Score >2; (14) Patients with active bacterial infection; (15) Patients whose vessel diameter of the carrier artery is not covered by the stent diameter; (16) The clinical life expectancy is less than 12 months; (17) Patients who cannot undergo general anesthesia; (18) Pregnant or lactating women; (19) Subjects who are participating in an ongoing clinical trial of any other drug or medical device; Or may participate in any other drug or medical device clinical trial during enrollment in this clinical trial; (20) The investigator determines that there are other conditions that are not suitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Aneurysm complete occlusion rate 12 months after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immediate operative success rate;Aneurysm complete occlusion rate 6 months after surgery;Rate of successful aneurysm occlusion 6 months after surgery;Rate of successful aneurysm occlusion 12 months after surgery;The percentage of aneurysmal bearing arteries that were open 12 months after surgery (stenosis rate =50%) and did not receive replacement therapy 12 months after surgery;The percentage of aneurysmal bearing arteries that were open (stenosis =50%) at 6 months and did not receive replacement therapy at 6 months after surgery; | — |
Countries
China
Contacts
Public ContactLiu Jianmin
Changhai Hospital of Shanghai
Outcome results
None listed