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ISRCTN
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ISRCTN34513421
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ClinicalTrials.gov identifier
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Public title
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Angioplasty with Stent in Symptomatic Intracranial Stenosis Trial-II
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Scientific title
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Acronym
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ASSIST–II
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Serial number at source
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2004BA714B-7
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Study hypothesis
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H0: Adjunctive stenting to optimal medical therapy is not superior to optimal medical therapy alone in reducing ipsilateral stroke risk in patients with symptomatic intracranial atherosclerotic stenoses.
H1: Adjunctive stenting to optimal medical therapy is superior to optimal medical therapy alone in reducing ipsilateral stroke risk in patients with symptomatic intracranial atherosclerotic stenoses.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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China
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Disease/condition/study domain
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Ischemic stroke
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Participants - inclusion criteria
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1. 18-75 years of age
2. ≥1 major atherosclerotic risk factors (arterial hypertension, hyperlipidemia, diabetes mellitus, hyperhomocystinemia and smoking)
3. Recurrent ischemic events (transient ischemic attack [TIA] and/or stroke) attributed to an intracranial stenosis ≥50% at digital subtraction angiography (DSA)
4. Evidence of perfusion deficit at the territory referable to the target stenosis in computed tomography (CT)-perfusion
5. The diameters of the parent arteries were between 2.0 to 4.0 mm, and length of stenoses <12 mm
6. Modified Rankin score ≤2 prior to last ischemic event
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Participants - exclusion criteria
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1. Stenosis of non-atherosclerotic origin (for example, vasculitis, Moya Moya disease and fibromuscular dysplasia)
2. Intracranial hemorrhage and major ischemic stroke (National Institutes of Health-Stroke-Scale [NIHSS] ≥8) in the same hemisphere as the target lesion within 6 weeks
3. A potential source of cardiac embolism
4. Concurrent intracranial tumors, cerebral arteriovenous malformation (AVM) and aneurysms
5. Presence of a neurological illness that can confound the diagnosis of TIA or stroke
6. Known contraindication to aspirin, clopidogrel, probucol, heparin, stainless steel, anesthesia, or X-ray contrast
7. Uncorrectable bleeding diathesis; previous stenting of the target artery
8. A positive pregnancy test
9. Life expectancy <1 year because of other medical conditions
10. Patients were not eligible if they could not cooperate with the study procedures or provide informed consent
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Anticipated start date
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01/09/2005
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Anticipated end date
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30/09/2009
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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399
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Interventions
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Stent-assisted angioplasty of the offending intracranial stenosis plus optimal medical therapy versus optimal medical therapy alone
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Primary outcome measure(s)
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1. Ipsilateral stroke, fatal or non-fatal, within 12 months
2. Events of clinically-driven emergency revascularization related to the treated stenosis
3. Modified Rankin score in 12 months
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Secondary outcome measure(s)
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1. Stroke and death unrelated to the target stenosis
2. Acute myocardial infarction in 12 months
3. Follow up cerebral angiography or magnetic resonance (MR) angiography, CT and CT-perfusion in 6 months
4. NIHSS in 12 months
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Sources of funding
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The Ministry of Health of The People's Republic of China
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Trial website
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http://www.strokecn.com
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Publications
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Contact name
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Dr
Wei-Jian
Jiang
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Address
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No. 6 Tiantan Xili
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City/town
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Beijing
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Zip/Postcode
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100050
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Country
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China
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Tel
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+86 1067050137
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Fax
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+86 1067050137
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Email
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cjr.jiangweijian@vip.163.com
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Sponsor
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The Ministry of Health of the People's Republic of China
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Address
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No.1 The South Road Of Xizhimenwai
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City/town
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Beijing
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Zip/Postcode
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100044
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Country
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China
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Email
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manluzhu@yahoo.com.cn
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Date applied
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16/08/2005
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Last edited
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01/10/2007
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Date ISRCTN assigned
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04/10/2005
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