Chinese Registry of Assisted Embolization for Ruptured Wide Necked Intracranial Aneurysm Using LVIS Stent
CRANIAL-2
1 other identifier
observational
200
1 country
1
Brief Summary
This study aims to investigating the efficacy and safety of low profile visualized intraluminal support (LVIS) stents for the treatment of ruptured intracranial saccular aneurysms. The follow-up duration is 1 year.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2016
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 6, 2016
CompletedFirst Posted
Study publicly available on registry
July 12, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2018
CompletedJuly 12, 2016
July 1, 2016
2 years
July 6, 2016
July 8, 2016
Conditions
Outcome Measures
Primary Outcomes (3)
Major adverse events (cerebral infarct, death) in 30 days post-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
During 30 days post-procedure
Complete occlusion rate 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
At 6 months (180±30d) follow-up
Modified Rankin Score at 1 year follow-up
The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
At 1 year follow-up
Secondary Outcomes (4)
Immediate technical success rate (successful device placement)
Within 24 hours postoperatively
Immediate complete occlusion rate
Within 24 hours postoperatively
Recurrence rate at 6 months (180±30d) follow-up
At 6 months (180±30d) follow-up
In-stent stenosis or obliteration rate at 6 months (180±30d) follow-up
At 6 months (180±30d) follow-up
Study Arms (1)
LVIS stents group
The patients with ruptured intracranial saccular aneurysm wil be treated with a LVIS stent without coils.
Interventions
Patients who meet the inclusion criteria will be treated with a low profile visualized intraluminal support (LVIS) stent with coils.
Eligibility Criteria
The targeted population was the patients with ruptured intracranial saccular aneurysms which located in the internal carotid artery or vertebra-basilar artery.
You may qualify if:
- Patients meeting all the following criteria will be enrolled:
- Patients of the age 18-75 years old.
- Patients diagnosed with ruptured intracranial saccular aneurysms via CTA, MRA or DSA.
- Patients treated with LVIS stents combined with coils.
- Patients willing to follow the clinical trial instructions and receive follow-up assessment.
- Patients accepting to participate to the study and sign the consent forms.
You may not qualify if:
- Patients meeting any following criterion will be excluded
- Patients without proper artery approach.
- Patients with AVM.
- Patients with a fusiform or dissecting aneurysm.
- Patients with a recurrent aneurysm.
- Patients treated with a LVIS stent without coils.
- Patients in poor clinical status, with mRS ≥4.
- Patients with life expectancy less than 12 months.
- Patients participated in other clinical trial, while has not reach the primary endpoint.
- Patients can not accept anti-platelet regimen.
- Patients allergic to contrast agent or intolerable.
- Patients whom the researchers consider should not participate in or continue this clinical trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Changhai Hospital
Shanghai, Shanghai Municipality, 200433, China
Related Publications (7)
Hong Y, Wang YJ, Deng Z, Wu Q, Zhang JM. Stent-assisted coiling versus coiling in treatment of intracranial aneurysm: a systematic review and meta-analysis. PLoS One. 2014 Jan 15;9(1):e82311. doi: 10.1371/journal.pone.0082311. eCollection 2014.
PMID: 24454690BACKGROUNDGeyik S, Yavuz K, Yurttutan N, Saatci I, Cekirge HS. Stent-assisted coiling in endovascular treatment of 500 consecutive cerebral aneurysms with long-term follow-up. AJNR Am J Neuroradiol. 2013 Nov-Dec;34(11):2157-62. doi: 10.3174/ajnr.A3574. Epub 2013 Jul 25.
PMID: 23886748BACKGROUNDPoncyljusz W, Bilinski P, Safranow K, Baron J, Zbroszczyk M, Jaworski M, Bereza S, Burke TH. The LVIS/LVIS Jr. stents in the treatment of wide-neck intracranial aneurysms: multicentre registry. J Neurointerv Surg. 2015 Jul;7(7):524-9. doi: 10.1136/neurintsurg-2014-011229. Epub 2014 May 14.
PMID: 24827067BACKGROUNDFiorella D, Arthur A, Boulos A, Diaz O, Jabbour P, Pride L, Turk AS, Woo HH, Derdeyn C, Millar J, Clifton A. Final results of the US humanitarian device exemption study of the low-profile visualized intraluminal support (LVIS) device. J Neurointerv Surg. 2016 Sep;8(9):894-7. doi: 10.1136/neurintsurg-2015-011937. Epub 2015 Sep 21.
PMID: 26391016BACKGROUNDYang P, Zhao K, Zhou Y, Zhao R, Zhang L, Zhao W, Hong B, Xu Y, Huang Q, Krings T, Liu J. Stent-assisted Coil Placement for the Treatment of 211 Acutely Ruptured Wide-necked Intracranial Aneurysms: A Single-Center 11-Year Experience. Radiology. 2015 Aug;276(2):545-52. doi: 10.1148/radiol.2015140974. Epub 2015 Mar 30.
PMID: 25822469BACKGROUNDFeng Z, Fang Y, Xu Y, Hong B, Zhao W, Liu J, Huang Q. The safety and efficacy of low profile visualized intraluminal support (LVIS) stents in assisting coil embolization of intracranial saccular aneurysms: a single center experience. J Neurointerv Surg. 2016 Nov;8(11):1192-1196. doi: 10.1136/neurintsurg-2015-012090. Epub 2016 Jan 8.
PMID: 26747876RESULTCho YD, Sohn CH, Kang HS, Kim JE, Cho WS, Hwang G, Kwon OK, Ko MS, Park NM, Han MH. Coil embolization of intracranial saccular aneurysms using the Low-profile Visualized Intraluminal Support (LVIS) device. Neuroradiology. 2014 Jul;56(7):543-51. doi: 10.1007/s00234-014-1363-x. Epub 2014 Apr 17.
PMID: 24740581RESULT
Study Officials
- PRINCIPAL INVESTIGATOR
Jianmin Liu, Doctor
Department of Neurosurgery, Changhai Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Deputy Director of Neurosurgery, Clinical Professor
Study Record Dates
First Submitted
July 6, 2016
First Posted
July 12, 2016
Study Start
June 1, 2016
Primary Completion
June 1, 2018
Study Completion
November 1, 2018
Last Updated
July 12, 2016
Record last verified: 2016-07