Intracranial aneurysm
Conditions
Interventions
Retrospective cohort:None
Prospective cohort:None
Sponsors
Xuanwu Hospital Capital Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Retrospective Study 1: No age restriction, no gender restriction. 2.Retrospective Study 2: The patient was treated with commercially available MicroVention WEB devices for intracranial aneurysms. 3.Retrospective Study 3: The patient has undergone at least one postoperative imaging re-examination. 4.Prospectiveness 1: No age or gender restrictions. 5.Prospectiveness 2: Patients are treated for intracranial aneurysms using the commercially available MicroVention WEB device. 6.Prospectiveness 3: The subjects (or their legal representatives, if applicable) shall fully understand the research requirements and procedures, and provide written informed consent prior to any research procedures being performed.
Exclusion criteria
Exclusion criteria: 1.Retrospective Study 1: Patients are treated with WEB devices, yet they cannot obtain imaging data from intraoperative or postoperative re-examinations. 2.Retrospective Study 2: Patients deemed ineligible by researchers to participate in this study. 3.Prospectiveness 1: The subject is participating in or plans to participate in another clinical study that may affect the results of this study during the follow-up period of this study. 4.Prospectiveness 2: The patient is currently or expected to be unavailable for follow-up. 5.Prospectiveness 3: The patient has a life expectancy of less than one year due to other diseases or conditions. 6.Prospectiveness 4: Researchers believe that these patients are not eligible to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| At the 12-month follow-up, the proportion of adequate aneurysm occlusion (Raymond grade I + II) based on the Raymond-Roy Occlusion Classification (RROC);Incidence Rate of Major Adverse Events (MAE); | — |
Secondary
| Measure | Time frame |
|---|---|
| Rebleeding within 1 year after surgery, excluding intraoperative rupture and rebleeding (only for ruptured aneurysms);1-year occlusion rate of residual aneurysm lesions with all grades of RROC (1-3) and WOS (A-D) for non-rebleeding (ruptured aneurysms) or retreated aneurysms;One-year occlusion rate without rebleeding at all grades of RROC(1-3) and WOS(A-D) (ruptured aneurysms);Unplanned retreatment or alternative treatment within 1 year (due to recurrence/residual aneurysm);The proportion of aneurysms achieving complete occlusion classified by WOS at the 12-month follow-up;Rebleeding within 30 days after surgery, excluding intraoperative rupture and rebleeding (only for ruptured aneurysms);1-year angiographic occlusion rates of aneurysms at all grades of RROC(1-3) and WOS(A-D);Nervous system events, including ischemic stroke, hemorrhagic stroke, neurological death, cerebral hemorrhage, SAH, arterial thrombosis, perforation/rupture of parent artery or branch artery, and TIA;Aneurysm recurrence (aneurysm enlargement or recanalization within one year);No new hemorrhage of target aneurysm within 1 year after surgery, excluding intraoperative rupture hemorrhage (only for unruptured aneurysms);Successful implantation of the device;Adverse events related to perioperative/postoperative devices or surgeries;30-day, 6-month and 1-year clinical outcomes (mRS);Device-related SAE;Retreatment of aneurysm within one year;Occlusion stability (showing no change, improvement or deterioration when comparing angiographic results at 6 months and 1 year);Patent parent artery at 1 year (vascular stenosis of parent artery less than 50% or absence of clinical symptoms within 1 year);Surgery-related SAE; | — |
Countries
China
Contacts
Public ContactZhang Hongqi
Xuanwu Hospital Capital Medical University
Outcome results
None listed