Chinese Registry of Assisted Embolization for Ruptured Wide Necked Intracranial Aneurysm Using LVIS Stent
NCT ID: NCT02830386
Last Updated: 2016-07-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2016-06-30
2018-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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LVIS stents group
The patients with ruptured intracranial saccular aneurysm wil be treated with a LVIS stent without coils.
LVIS stent
Patients who meet the inclusion criteria will be treated with a low profile visualized intraluminal support (LVIS) stent with coils.
Interventions
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LVIS stent
Patients who meet the inclusion criteria will be treated with a low profile visualized intraluminal support (LVIS) stent with coils.
Eligibility Criteria
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Inclusion Criteria
1. Patients of the age 18-75 years old.
2. Patients diagnosed with ruptured intracranial saccular aneurysms via CTA, MRA or DSA.
3. Patients treated with LVIS stents combined with coils.
4. Patients willing to follow the clinical trial instructions and receive follow-up assessment.
5. Patients accepting to participate to the study and sign the consent forms.
Exclusion Criteria
1. Patients without proper artery approach.
2. Patients with AVM.
3. Patients with a fusiform or dissecting aneurysm.
4. Patients with a recurrent aneurysm.
5. Patients treated with a LVIS stent without coils.
6. Patients in poor clinical status, with mRS ≥4.
7. Patients with life expectancy less than 12 months.
8. Patients participated in other clinical trial, while has not reach the primary endpoint.
9. Patients can not accept anti-platelet regimen.
10. Patients allergic to contrast agent or intolerable.
11. Patients whom the researchers consider should not participate in or continue this clinical trial.
18 Years
75 Years
ALL
No
Sponsors
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Changhai Hospital
OTHER
Responsible Party
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Qinghai Huang
Deputy Director of Neurosurgery, Clinical Professor
Principal Investigators
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Jianmin Liu, Doctor
Role: PRINCIPAL_INVESTIGATOR
Department of Neurosurgery, Changhai Hospital
Locations
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Changhai Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Geyik 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.
Poncyljusz 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.
Fiorella 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.
Yang 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.
Feng 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.
Cho 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.
Other Identifiers
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CHEC2016-059
Identifier Type: -
Identifier Source: org_study_id
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