Prospective

Miss Annie Chan

Division of Neurology, Department of Medicine and Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong

852- 26352152/ 852- 26323856

anniechanclc@cuhk.edu.hk

Trial Co-ordinator

Dr. Thomas WH Leung

Division of Neurology, Department of Medicine and Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong

852- 26352152/ 852- 26323856

drtleung@cuhk.edu.hk

Principal Investigator

Yes

2006-09-21

Procedure

To investigate the safety and efficacy of early adjunctive stenting in patients with symptomatic intracranial stenosis (within 6 weeks from the index ischemic stroke) vs medical therapy alone

The patients will be followed up for 12 months

The stent used in the study is Wingspan system, which consists of a self-expanding nitinol stent; a multi-lumen over-the-wire delivery catheter; and Gateway PTA Balloon Catheter. The system is authorized by US federal law for use in improving cerebral artery lumen diameter in patients with intracranial atherosclerotic disease, refractory to medical therapy, in intracranial vessels >50% stenosis that are accessible to the system.

Inclusion Criteria: 1)Patient is at least 18 to 80 years of age, inclusive. 2)Acute ischemic stroke (within 4 weeks) attributable to a >70% stenosis of an intracranial artery (i.e. C6/7 internal carotid artery, M1 middle cerebral artery, V4 vertebral artery, or basilar artery) evidenced in DSA. 3)The target intracranial artery has a normal diameter of 2.00 mm to 4.5 mm; and the target area of stenosis is less than or equal to 14 mm in length 4)A modified Rankin score of <3. 5)Patient understands the purpose and requirements of the study, can make him/herself understood, and has provided informed consent

Exclusion Criteria: 1)Any medical condition that would not allow the patient to adhere to the protocol or complete the study 2)Patients for whom the required medications for the study are contra-indicated. 3)Brain infarct within previous 30 days of enrollment that is of sufficient size (> 5 cms) to be at risk of hemorrhagic conversion during or after stenting 4)Active peptic ulcer disease, history of intracerebral (parenchymal) hemorrhage, major systemic hemorrhage within 30 days, active bleeding diathesis, platelets <100,000, hematocrit <30, INR >1.5, clotting factor abnormality that increases the risk of bleeding, alcohol or substance abuse, uncontrolled severe hypertension (systolic pressure > 180 mm Hg or diastolic pressure > 115mm Hg), severe liver impairment (SGOT > 3 x normal, cirrhosis), creatinine > 3.0 (unless on dialysis) 5)Stroke etiology other than intracranial atherosclerosis, such as cardioembolism (atrial fibrillation, prosthetic heart valve, myocardial infarction within 6 weeks, mitral stenosis, intracardiac clot, bacterial endocarditis, or ventricular aneurysm), or a tandem high-grade (>70%) proximal extra-cranial carotid or vertebral stenosis. 6)Non-atherosclerotic intracranial stenosis, such as MoyaMoya disease, fibromuscular dysplasia, vasculitis or dissection. 7)Women who are pregnant or intend to become pregnant during the study. 8)Known intracranial tumor, arterio-venous malformation or aneurysm. 9)Life expectancy less than one year. 10)Previous intracranial stenting of the target artery. 11)Major surgical operation within the past 30 days.

18

80

Both Male and Female

Randomized

Active

Open label

Single group

No

Yes

111 patients have been randomized