Angioplasty with Stent in Symptomatic Intracranial Stenosis Trial-II

Completed

• Conditions: Ischemic stroke; Circulatory System

• Registration Number: ISRCTN34513421
• Lead Sponsor: The Ministry of Health of the People's Republic of China

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10-04
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 399

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Ipsilateral stroke, fatal or non-fatal, within 12 months<br>2. Events of clinically-driven emergency revascularization related to the treated stenosis<br>3. Modified Rankin score in 12 months

Secondary Outcome Measures

Name	Time	Method
1. Stroke and death unrelated to the target stenosis<br>2. Acute myocardial infarction in 12 months<br>3. Follow up cerebral angiography or magnetic resonance (MR) angiography, CT and CT-perfusion in 6 months<br>4. NIHSS in 12 months