Angioplasty with Stent in Symptomatic Intracranial Stenosis Trial-II
| ISRCTN | ISRCTN34513421 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34513421 |
| Secondary identifying numbers | 2004BA714B-7 |
- Submission date
- 16/08/2005
- Registration date
- 04/10/2005
- Last edited
- 01/10/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Wei-Jian Jiang
Scientific
Scientific
No. 6 Tiantan Xili
Beijing
100050
China
| Phone | +86 1067050137 |
|---|---|
| cjr.jiangweijian@vip.163.com |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | ASSISTII |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Ischemic stroke |
| Intervention | Stent-assisted angioplasty of the offending intracranial stenosis plus optimal medical therapy versus optimal medical therapy alone |
| Intervention type | Other |
| Primary outcome measure | 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 study start date | 01/09/2005 |
| Completion date | 30/09/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | 399 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2005 |
| Date of final enrolment | 30/09/2009 |
Locations
Countries of recruitment
- China
Study participating centre
No. 6 Tiantan Xili
Beijing
100050
China
100050
China
Sponsor information
The Ministry of Health of the People's Republic of China
Government
Government
No.1 The South Road Of Xizhimenwai
Beijing
100044
China
| manluzhu@yahoo.com.cn | |
"ROR" |
https://ror.org/01mv9t934 |
Funders
Funder type
Government
The Ministry of Health of The People's Republic of China
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
