Angioplasty and Stenting for Patients With Symptomatic Intracranial Atherosclerosis: Study Protocol of a Randomized Controlled Trial
Overview
- Phase
- Phase 3
- Intervention
- Percutaneous transluminal angioplasty and stenting
- Conditions
- Intracranial Atherosclerosis
- Sponsor
- The 476th Hospital of People's Liberation Army
- Enrollment
- 394
- Primary Endpoint
- Proportion of patients with events of stroke or death
- Last Updated
- 10 years ago
Overview
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.
Investigators
Feng-Feng Shen
Doctor
The 476th Hospital of People's Liberation Army
Eligibility Criteria
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
Arms & Interventions
stenting+medical treatment
Patients in PTAS+MT group will receive Percutaneous transluminal angioplasty and stenting and medical treatment (aspirin 100mg daily and clopidogrel 75mg daily)
Intervention: Percutaneous transluminal angioplasty and stenting
stenting+medical treatment
Patients in PTAS+MT group will receive Percutaneous transluminal angioplasty and stenting and medical treatment (aspirin 100mg daily and clopidogrel 75mg daily)
Intervention: Aspirin plus clopidogrel
Aspirin plus clopidogrel
Patients in aspirin plus clopidogrel group will receive aspirin 100mg daily and clopidogrel 75mg daily for 90 days.
Intervention: Aspirin plus clopidogrel
Outcomes
Primary Outcomes
Proportion of patients with events of stroke or death
Time Frame: at 30 days after randomization
Secondary Outcomes
- 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)