Angioplasty and Stenting for Patients With Symptomatic Intracranial Atherosclerosis

Phase 3

• Conditions: Intracranial Atherosclerosis
• Interventions: Procedure: Percutaneous transluminal angioplasty and stenting; Drug: Aspirin plus clopidogrel

• Registration Number: NCT02689037
• Lead Sponsor: The 476th Hospital of People's Liberation Army

Brief Summary

Background: Effectiveness of Percutaneous transluminal angioplasty and stenting (PTAS) on prevention of events of stroke and death in patients with symptomatic intracranial atherosclerosis (ICAS) is controversial.

Aim: to determine whether PTAS plus medical treatment (MT) are superior to MT alone in preventing events of stroke and death in patients with symptomatic ICAS.

Methods: The investigators will carry out a randomized controlled trial in 3 hospitals in China. A total of 198 patients with ICAS will be randomized into 2 groups: PTAS+MT and MT group. All patients will receive aspirin (100 mg daily) and clopidogrel (75 mg daily) immediately after randomization, and patients in PTAS+MT group will receive surgery within 5 days after randomization. The patients will be followed up for 1 year after randomization and assessed for events of stroke and death at 30 days and 1 year after randomization, the incidence of recurrent ischaemic stroke in the stenting-involved vascular territory at 30 days and 1 year after randomization, incidence of in-stent restenosis at 1 year after randomization,etc.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-17
• Study First Submitted QC: 2016-02-18
• Study First Posted: 2016-02-23
• Status Verified: 2016-04
• Study Start: 2016-04
• Last Update Submitted: 2016-04-04
• Last Update Posted: 2016-04-05
• Primary Completion: 2018-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 394

Inclusion Criteria

• Patients aged from 18 to 70 years.
• Complaints of a Symptomatic ICAS: a history of recurrent transient ischemic attacks or an ischemic stroke within 1 year owing to a 70%-99% stenosis in an internal carotid artery, middle cerebral artery, vertebral artery, or basilar artery.
• A length ≤ 15mm of a stenosis in the target vessel and a vessel size >2.5mm.
• Hypoperfusion in the territory of the target vessels, which is determined by CT or MRI in 14 days before stenting.
• CT or MRI scans show no massive cerebral infarction (beyond half of the territory of middle cerebral artery (MCA)), intracranial hemorrhage, epidural or sub-dural hemorrhage, and intracranial brain tumor.
• Patients who understand the purpose of the study and have provided informed consent.

Exclusion Criteria

• Not able to receive general anesthesia.
• Not able to receive angiographic assessment.
• A stenosis >50% in an extracranial carotid or vertebral artery on the ipsilateral side.
• Infarctions due to the perforators occlusion (determined by MRI scan), which is defined as basal ganglia or brainstem/thalamus infarction related with middle cerebral artery or basilar artery stenosis.
• A high risk (leading to a stroke or death) to deliver the stent to the lesion.
• A previous stent or angioplasty in the target lesion.
• Progressive neurological signs within 24 hours before enrolment
• Any haemorrhagic infarct within 14 days before enrolment
• The presence of a cardiac source of embolus
• Thrombolytic therapy within 24 hours before enrollment
• Presence of intraluminal thrombus proximal to or at the target lesion
• Myocardial infarction within previous 30 days
• Non-atherosclerotic lesions: arterial dissection, moya-moya disease; vasculitic disease; herpes zoster, varicella zoster or other viral vasculopathy; neurosyphilis; any other intracranial infection; any intracranial stenosis associated with cerebrospinal fluid pleocytosis; radiation-induced vasculopathy; fibromuscular dysplasia; sickle cell disease; neurofibromatosis; benign angiopathy of central nervous system; postpartum angiopathy; suspected vasospastic process, and suspected recanalized embolus.
• Known contraindications for aspirin and clopidogrel treatment.
• An modified Rankin scale≥3.
• With a childbearing potential or a positive pregnancy test in 1 week before enrolment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
stenting+medical treatment	Percutaneous transluminal angioplasty and stenting	Patients in PTAS+MT group will receive Percutaneous transluminal angioplasty and stenting and medical treatment (aspirin 100mg daily and clopidogrel 75mg daily)
stenting+medical treatment	Aspirin plus clopidogrel	Patients in PTAS+MT group will receive Percutaneous transluminal angioplasty and stenting and medical treatment (aspirin 100mg daily and clopidogrel 75mg daily)
Aspirin plus clopidogrel	Aspirin plus clopidogrel	Patients in aspirin plus clopidogrel group will receive aspirin 100mg daily and clopidogrel 75mg daily for 90 days.

Primary Outcome Measures

Name	Time	Method
Proportion of patients with events of stroke or death	at 30 days after randomization

Secondary Outcome Measures

Name	Time	Method
neurological functional outcome by the Chinese version of National Institutes of Health Stroke Scale (C-NIHSS)	30 days and 1 year after randomization
Proportion of patients with adverse events	30 days and 1 year after randomization
the incidence of recurrent ischaemic stroke in the stenting-involved vascular territory	30 days and 1 year after randomization