Arterial aneurysm
Conditions
Interventions
treatment group:Intracranial stent system produced by Changyida was used
control group:The LVIS Intraluminal Support Device, an intracranial stent system manufactured by MicroVention, was used
Sponsors
Changhai Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Age >=18 years old and <=80 years old; 2) Untreated, unruptured aneurysm confirmed by imaging diagnosis before surgery; 3) The investigators judged that the target aneurysm was suitable for intracranial stent system for intravascular treatment; 4) The diameter of the tumor bearing artery measured by imaging was 1.5mm ~ 5.5mm; 5) The subject or his legal guardian can understand the purpose of the study, demonstrate sufficient compliance with the study protocol, and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1) The target aneurysm has previously received craniotomy surgery or other intravascular intervention; 2) Target aneurysms are blood vesicular aneurysms, infectious aneurysms, pseudoaneurysms, arteriovenous malformation or moyamoya disease related aneurysms; 3) There are space-occupying lesions such as intracranial hematoma or brain tumor unrelated to the target aneurysm; 4) Poor clinical status, mRS Score >=3; 5) The vascular path is tortuous or there is serious arteriosclerosis and stenosis, it is expected that the instrument is difficult to reach the target vessel; 6) Patients who cannot receive antiplatelet aggregation and/or anticoagulation therapy; 7) Patients who are known to have definite allergies to nickel-titanium alloy and platinum-tungsten alloy; 8) Those who are known to be severely allergic to contrast agents (rashes are excluded); 9) Preoperative complications of serious heart, liver, kidney, respiratory system diseases and coagulation disorders; 10) Pregnant or lactating women, or those who plan to give birth within the next year; 11) Life expectancy is less than 1 year; 12) is participating in any other drug or medical device clinical trial, or may participate in any other drug or medical device clinical trial after enrollment in this clinical trial; 13) The investigator determines that there are other conditions that are not suitable for participation in this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Successful occlusion rate of aneurysm ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pstoperative success rate (success rate of stent implantation);;Aneurysmal embolization rate ;Aneurysm recurrence rate ;Aneurysm complete occlusion rate ; | — |
Countries
China
Contacts
Public ContactJianmin Liu
Changhai Hospital
Outcome results
None listed