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AJNR Awards, New Junior Editors, and more. Read the latest AJNR updates

Research ArticleNeurointervention
Open Access

Multicenter Prospective Trial of Stent Placement in Patients with Symptomatic High-Grade Intracranial Stenosis

P. Gao, D. Wang, Z. Zhao, Y. Cai, T. Li, H. Shi, W. Wu, W. He, L. Yin, S. Huang, F. Zhu, L. Jiao, X. Ji, A.I. Qureshi and F. Ling
American Journal of Neuroradiology July 2016, 37 (7) 1275-1280; DOI: https://doi.org/10.3174/ajnr.A4698
P. Gao
aFrom the Department of Neurosurgery (P.G., F.Z., L.J., X.J., F.L.), Xuanwu Hospital, Capital Medical University, Beijing, China
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D. Wang
bDepartment of Neurosurgery (D.W.), Beijing Hospital of the Ministry of Health, Beijing, China
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Z. Zhao
cDepartment of Neurosurgery (Z.Z.), Tangdu Hospital, the Fourth Military Medical University, Xi'an, Shaanxi Province, China
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Y. Cai
dDepartment of Neurology (Y.C.), the 306 Hospital of the People's Liberation Army, Beijing, China
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T. Li
eDepartment of Intervention (T.L.), Henan Provincial People's Hospital, Zhengzhou, Henan Province, China
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H. Shi
fDepartment of Neurosurgery (H.S.), the 1st Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang Province, China
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W. Wu
gDepartment of Neurology (W.W.), Qilu Hospital of Shandong University, Ji'nan, Shandong Province, China
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W. He
hDepartment of Neurosurgery (W.H.), the 2nd Affiliated Hospital of Guangzhou Medical College, Guangzhou, Guangdong Province, China
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L. Yin
iDepartment of Neurosurgery (L.Y.), Tianjin Huanhu Hospital, Tianjin, China
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S. Huang
jDepartment of Neurosurgery (S.H.), Guangdong Province Hospital of Traditional Chinese Medicine, Guangzhou, Guangdong Province, China
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F. Zhu
aFrom the Department of Neurosurgery (P.G., F.Z., L.J., X.J., F.L.), Xuanwu Hospital, Capital Medical University, Beijing, China
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L. Jiao
aFrom the Department of Neurosurgery (P.G., F.Z., L.J., X.J., F.L.), Xuanwu Hospital, Capital Medical University, Beijing, China
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X. Ji
aFrom the Department of Neurosurgery (P.G., F.Z., L.J., X.J., F.L.), Xuanwu Hospital, Capital Medical University, Beijing, China
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A.I. Qureshi
kZeenat Qureshi Stroke Institute (A.I.Q.), St. Cloud, Minnesota.
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F. Ling
aFrom the Department of Neurosurgery (P.G., F.Z., L.J., X.J., F.L.), Xuanwu Hospital, Capital Medical University, Beijing, China
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    Table 1:

    Inclusion criteria

    Criteria
    1) Eligible patients between 30 and 80 years of age; intracranial arterial stenosis will not be considered if related to the following: nonatherosclerotic factors: arterial dissection, Moyamoya disease; vasculitic disease; herpes zoster, varicella zoster, or other viral vasculopathies; neurosyphilis; any other intracranial infection; any intracranial stenosis associated with CSF pleocytosis; radiation-induced vasculopathy; fibromuscular dysplasia; sickle cell disease; neurofibromatosis; benign angiopathy of the central nervous system; postpartum angiopathy; suspected vasospastic process; and suspected recanalized embolus
    2) Symptomatic intracranial stenosis: presenting with TIA or stroke within the past 12 months attributed to 70%–99% stenosis of a major intracranial artery (internal carotid artery, MCA [M1], vertebral artery, or basilar artery)
    3) Degree of stenosis: 70%–99% severity confirmed by catheter angiography for enrollment in the trial
    4) Remote infarctions on MRI were acceptable, which could be accounted for by the occlusion of the terminal cortical branches or hemodynamic compromise (perforator strokes excluded); perforator strokes due to perforator occlusion are defined as basal ganglia or brain stem/thalamus infarction related with middle cerebral artery or basilar artery stenosis
    5) Expected ability to deliver the stent to the lesion
    6) All patients should be treated beyond a duration of 3 weeks from the latest ischemic symptom onset
    7) No recent infarctions identified on MRI (indicated as high signals on DWI series) at enrollment
    8) No massive cerebral infarction (more than one-half of the MCA territory), intracranial hemorrhage, epidural or subdural hemorrhage, and intracranial brain tumor on CT or MRI
    9) mRS score of ≤2
    10) Target vessel reference diameter must be measured at 2.00–4.50 mm; target area of stenosis is ≤14 mm in length
    11) No childbearing potential or has a test negative for pregnancy within the week prior to study procedure; female patients had normal menses in the past 18 months
    12) Patient is willing and able to return for all follow-up visits required by the protocol
    13) Patients understand the purpose and requirements of the study and have signed an informed consent form
    • View popup
    Table 2:

    Demographic and clinical characteristics of the patients treated in the single-arm trial

    Baseline Demographics
    Age (median) (IQR)56.0 (49–63)
    Men (No.) (%)73 (73%)
    Risk factors
        Hypertension (No.) (%)61 (61%)
        Hyperlipidemia (No.) (%)15 (16%)
        Diabetes mellitus (No.) (%)25 (28%)
        History of cigarette smoking (No.) (%)44 (44%)
        History of alcoholism (No.) (%)28 (28%)
        Ischemic stroke as qualifying event (No.) (%)50 (50%)
    NIHSS sores at admission (median) (IQR)0 (0–1)
    mRS scores at admission (median) (IQR)0 (0–1)
    Barthel Index at admission (median) (IQR)100 (100–100)
    Angiographic characteristics
    Preprocedure: average degree of stenosis (%)82.7 ± 8.9
    Location
        Basilar artery27 (27%)
        Intracranial internal carotid artery17 (17%)
        Middle cerebral artery38 (38%)
        Intradural vertebral artery18 (18%)
    Postprocedure: average stenosis (%)13.5 ± 10.2
    • Note:—IQR indicates interquartile range.

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American Journal of Neuroradiology: 37 (7)
American Journal of Neuroradiology
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Cite this article
P. Gao, D. Wang, Z. Zhao, Y. Cai, T. Li, H. Shi, W. Wu, W. He, L. Yin, S. Huang, F. Zhu, L. Jiao, X. Ji, A.I. Qureshi, F. Ling
Multicenter Prospective Trial of Stent Placement in Patients with Symptomatic High-Grade Intracranial Stenosis
American Journal of Neuroradiology Jul 2016, 37 (7) 1275-1280; DOI: 10.3174/ajnr.A4698

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Multicenter Prospective Trial of Stent Placement in Patients with Symptomatic High-Grade Intracranial Stenosis
P. Gao, D. Wang, Z. Zhao, Y. Cai, T. Li, H. Shi, W. Wu, W. He, L. Yin, S. Huang, F. Zhu, L. Jiao, X. Ji, A.I. Qureshi, F. Ling
American Journal of Neuroradiology Jul 2016, 37 (7) 1275-1280; DOI: 10.3174/ajnr.A4698
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