Protocol for a prospective, multicentre registry study of stenting for symptomatic intracranial artery stenosis in China

Miao, Zhongrong; Wang, Y.; Wang, Wenjuan; Gao, Peiyi; Liu, L.; Wang, F.; Liu, Y.; Ma, Ning; Xu, Ziqi; Mo, Dapeng; Gao, Feng

doi:10.1136/bmjopen-2014-005175

Cited by 17 publications

(15 citation statements)

References 19 publications

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“…18 This study was a prospective single-arm registry study with 20 participating sites. Approval by each site's institutional review board or ethics committee was obtained.…”

Section: Overall Designmentioning

confidence: 99%

Thirty-Day Outcome of a Multicenter Registry Study of Stenting for Symptomatic Intracranial Artery Stenosis in China

Miao

Zhang

Shuai

et al. 2015

Stroke

108

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Background and Purpose-Although recent trials have suggested that stenting is worse than medical therapy for patients with severe symptomatic intracranial atherosclerotic stenosis, it is not clear whether this conclusion applies to a subset of patients with hypoperfusion symptoms. To justify for a new trial in China, we performed a multicenter prospective registry study to evaluate the safety and efficacy of endovascular stenting within 30 days for patients with severe symptomatic intracranial atherosclerotic stenosis. Methods-Patients with symptomatic intracranial atherosclerotic stenosis caused by 70% to 99% stenosis combined with poor collaterals were enrolled. The patients were treated either with balloon-mounted stent or with balloon predilation plus self-expanding stent as determined by the operators following a guideline. The primary outcome within 30 days is stroke, transient ischemic attack, and death after stenting. The secondary outcome is successful revascularization. The baseline characteristics and outcomes of the 2 treatment groups were compared. Results-From September 2013 to January 2015, among 354 consecutive patients, 300 patients (aged 58.3±9.78 years) were recruited, including 159 patients treated with balloon-mounted stent and 141 patients with balloon plus self-expanding stent. The 30-day rate of stroke, transient ischemic attack, and death was 4.3%. Successful revascularization was 97.3%. Patients treated with balloon-mounted stent were older, less likely to have middle cerebral artery lesions, more likely to have vertebral artery lesions, more likely to have Mori A lesions, less likely to have Mori C lesions, and likely to have lower degree of residual stenosis than patients treated with balloon plus self-expanding stent. Conclusions-The short-term safety and efficacy of endovascular stenting for patients with severe symptomatic intracranial atherosclerotic stenosis in China is acceptable. Balloon-mounted stent may have lower degree of residual stenosis than self-expanding stent. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01968122.

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“…18 This study was a prospective single-arm registry study with 20 participating sites. Approval by each site's institutional review board or ethics committee was obtained.…”

Section: Overall Designmentioning

confidence: 99%

Thirty-Day Outcome of a Multicenter Registry Study of Stenting for Symptomatic Intracranial Artery Stenosis in China

Miao

Zhang

Shuai

et al. 2015

Stroke

108

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“…In the VISSIT (the Vitesse Intracranial Stent Study for Ischemic Stroke Therapy) trial, worse outcomes after stenting were also shown with a different (i.e., balloon expanding) stent in comparison with medical therapy in symptomatic intracranial atherosclerotic stenosis (24% vs. 9% at 30 days, 36% vs. 15% at 12 months follow‐up) (Compter et al., ; Derdeyn et al., ; Zaidat et al., ). Despite the disappointing performance of intracranial stenting in both VISSIT and SAMMPRIS, it is possible that improvement of operator experience and periprocedural factors such as blood pressure management may lead to improved outcomes after stenting in future trials (Wang et al., ; Zaidat et al., ). Newer stent technology could possibly also enhance the safety and success of future endovascular procedures (Zaidat et al., ).…”

Section: Treatment Of Intracranial Atherosclerotic Stenosismentioning

confidence: 99%

“…Newer stent technology could possibly also enhance the safety and success of future endovascular procedures (Zaidat et al., ). Device selection based on arterial access and lesion morphology is currently implemented in a large Chinese study (Wang et al., ), in which self‐expanding stents are preferably used in patients with tortuous arterial access, while balloon‐expandable stents are preferred in patients with smoother access.…”

Section: Treatment Of Intracranial Atherosclerotic Stenosismentioning

confidence: 99%

“…Since patients presenting with perforator ischemia possibly have an excessive risk of periprocedural stroke (due to occluding stenosed perforators by plaque shifting), these patients are excluded in a new multicenter randomized clinical trial (Gao et al., ). In a prospective registry study that evaluates stenting of symptomatic ICAS (Wang et al., ), imaging features are used for patient selection in addition to the degree of stenosis. For inclusion, hypoperfusion has to be demonstrated by means of reduced blood flow on CT perfusion or SPECT, poor collaterals on DSA, hemodynamic ischemic lesion on MRI, or high peak systolic velocities on TCD (Wang et al., ).…”

Section: Treatment Of Intracranial Atherosclerotic Stenosismentioning

confidence: 99%

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Treatment and imaging of intracranial atherosclerotic stenosis: current perspectives and future directions

et al. 2016

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Background and PurposeIntracranial atherosclerosis is a common cause of stroke worldwide. It results in ischemic stroke due to different mechanisms including artery‐to‐artery embolism, in situ thrombo‐occlusion, occlusion of perforating arteries, and hemodynamic failure. In this review, we present an overview of current treatment and imaging modalities in intracranial atherosclerotic stenosis.MethodsPubMed was searched for relevant articles in English that evaluated the treatment and imaging of intracranial atherosclerotic stenosis (ICAS).ResultsAggressive medical management, consisting of dual antiplatelet therapy and intensive risk factor management, is important in patients with ICAS because of a substantial risk of recurrent stroke, approximately 20% in the first year, in patients on aspirin or warfarin alone. Recent trials have suggested that, aggressive medical therapy results in better outcome as compared with intracranial stenting. However, the question remains what the optimal treatment strategy would be in patients with recurrent strokes in the setting of failed aggressive medical therapy. Moreover, controversy exists whether a subgroup of patients with symptomatic ICAS could benefit from intracranial stenting if selection is based on radiological evidence of hemodynamic failure. With regard to imaging, transcranial Doppler ultrasound and magnetic resonance angiography are useful screening tests for exclusion of ICAS, but need confirmation by other imaging modalities when stenosis is suggested. Computed tomography angiography has a high positive and negative predictive value for detection of intracranial luminal stenosis of 50% or higher, but performs worse than digital subtraction angiography with regard to establishing the exact degree of luminal stenosis. Novel imaging techniques including high‐resolution CT and MRI better identify plaque characteristics than conventional imaging methods.ConclusionsCurrently, aggressive medical management remains the standard of care for patients with ICAS. Further research is needed to identify high‐risk subgroups and to develop more effective treatments for ICAS patients.

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“…15 16 The first one was a single-centre randomised trial, the results of which demonstrated that PTAS is as effective as medical treatment 16. The result of the second study, a multicentre registry study, showed that the incidence of stroke, transient ischaemic attack (TIA) and death in 30 days after stenting was 4.3%, which is lower than the incidence in the SAMMPRIS trial 17.…”

Section: Introductionmentioning

confidence: 99%

Angioplasty and stenting for patients with symptomatic intracranial atherosclerosis: study protocol of a randomised controlled trial

Chen

Lin

et al. 2016

BMJ Open

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IntroductionWhether adding percutaneous transluminal angioplasty and stenting (PTAS) to background medical treatment is effective for decreasing the incidence of stroke or death in patients with symptomatic intracranial atherosclerosis (ICAS) is still controversial. We perform a randomised controlled trial to examine the effectiveness and safety of an improved PTAS procedure for patients with ICAS.Methods and analysisA randomised controlled trial will be conducted in three hospitals in China. Eligible patients with ICAS will be randomly assigned to receive medication treatment (MT) plus PTAS or MT alone. The MT will be initiated immediately after randomisation, while the PTAS will be performed when patients report relief of alarm symptoms defined as sudden weakness or numbness. All patients will be followed up at 30 days, 3 and 12 months after randomisation. The primary end point will be the incidence of stroke or death at 30 days after randomisation. Secondary outcomes will be the incidence of ischaemic stroke in the territory of stenosis arteries, the incidence of in-stent restenosis, the Chinese version of the modiﬁed Rankin Scale and the Chinese version of the Stroke-Specific Quality of Life (CSQoL).Ethics and disseminationThe study protocol is approved by institutional review boards in participating hospitals (reference number FZ20160003, 180PLA20160101 and 476PLA2016007). The results of this study will be disseminated to patients, physicians and policymakers through publication in a peer-reviewed journal or presentations in conferences. It is anticipated that the results of this study will improve the quality of the current PTAS procedure and guide clinical decision-making for patients with ICAS.Trial registration numberNCT02689037

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Protocol for a prospective, multicentre registry study of stenting for symptomatic intracranial artery stenosis in China

Cited by 17 publications

References 19 publications

Thirty-Day Outcome of a Multicenter Registry Study of Stenting for Symptomatic Intracranial Artery Stenosis in China

Thirty-Day Outcome of a Multicenter Registry Study of Stenting for Symptomatic Intracranial Artery Stenosis in China

Treatment and imaging of intracranial atherosclerotic stenosis: current perspectives and future directions

Angioplasty and stenting for patients with symptomatic intracranial atherosclerosis: study protocol of a randomised controlled trial

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