Chinese Registry of Assisted Embolization for Unruptured Wide Necked Intracranial Aneurysm Using LVIS Stent (CRANIAL-1)
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|ClinicalTrials.gov Identifier: NCT02830373|
Recruitment Status : Unknown
Verified July 2016 by Qinghai Huang, Changhai Hospital.
Recruitment status was: Recruiting
First Posted : July 12, 2016
Last Update Posted : July 12, 2016
|Condition or disease||Intervention/treatment|
|Self Efficacy Medical Device Complication||Device: LVIS stents|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Chinese Registry of Assisted Embolization for Unruptured Wide Necked Intracranial Aneurysm Using LVIS Stent|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||October 2018|
LVIS stents group
patients with unruptured intracranial saccular aneurysms which located in the internal carotid artery or vertebra-basilar artery will be treated with a LVIS stent with coils
Device: LVIS stents
Patients who meet the inclusion criteria will be treated with a low profile visualized intraluminal support (LVIS) stent with coils.
- Major adverse events (cerebral infarct, death) in 30 days post the procedure [ Time Frame: During 30 days post the procedure ]Major adverse events (cerebral infarct, death) in 30 days post the procedure is defined as post-procedural cerebral infarct or death caused by any reasons
- Complete occlusion rate at 6 months (180±30d) follow-up [ Time Frame: At 6 months (180±30d) follow-up ]Complete occlusion at 6 months follow-up is defined as 100% occlusion of aneurysmal sac proved by DSA at 6 months follow-up
- Immediate technical success rate (successful device placement) [ Time Frame: Within 24 hours postoperatively ]Immediate technical successful is defined as good apposition of stents, effective coverage of aneurysmal neck proved by post-procedural imaging examination.
- Immediate complete occlusion rate [ Time Frame: Within 24 hours postoperatively ]Immediate Raymond scale is defined as immediate angiographic result according to the simplified Raymond scale, classⅠ: complete occlusion; class Ⅱ: neck remnant; class Ⅲ: incomplete occlusion.
- Recurrence rate at 6 months (180±30d) follow-up [ Time Frame: At 6 months (180±30d) follow-up ]Recurrence rate: defined as increased contrast filling into the aneurysmal sac compared with immediate angiographic result.
- In-stent stenosis or obliteration rate at 6 months (180±30d) follow-up [ Time Frame: At 6 months (180±30d) follow-up ]In-stent stenosis at 6 months follow-up is defined as stenosis more than 50% proved by DSA at 6 months follow-up. In-stent occlusion or thrombosis at 6 months follow-up is defined as complete occlusion of the stent proved by DSA at 6 months follow-up.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02830373
|Contact: Qinghai Huang, Doctoremail@example.com|
|Contact: Yongxin Zhang, Doctorfirstname.lastname@example.org|
|Principal Investigator:||Jianmin Liu, Doctor||Department of Neurosurgery, Changhai Hospital|