Contact information
Type
Scientific
Primary contact
Dr Wei-Jian Jiang
ORCID ID
Contact details
No. 6 Tiantan Xili
Beijing
100050
China
+86 1067050137
cjr.jiangweijian@vip.163.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2004BA714B-7
Study information
Scientific title
Acronym
ASSISTII
Study hypothesis
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.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Ischemic stroke
Intervention
Stent-assisted angioplasty of the offending intracranial stenosis plus optimal medical therapy versus optimal medical therapy alone
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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
Secondary outcome measures
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
Overall trial start date
01/09/2005
Overall trial end date
30/09/2009
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
399
Participant exclusion criteria
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
Recruitment start date
01/09/2005
Recruitment end date
30/09/2009
Locations
Countries of recruitment
China
Trial participating centre
No. 6 Tiantan Xili
Beijing
100050
China
Sponsor information
Organisation
The Ministry of Health of the People's Republic of China
Sponsor details
No.1 The South Road Of Xizhimenwai
Beijing
100044
China
manluzhu@yahoo.com.cn
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
The Ministry of Health of The People's Republic of China
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary