None listed
Conditions
Brief summary
Introduction: Recent studies indicated that endovascular stenting is inferior to aggressive medication for reducing cerebrovascular events in patients with symptomatic intracranial stenosis(ICAS). However, a high rate of postprocedure complications and a biased selection of patients raised concerns about the accuracy and stability of the results. Hence, we designed a randomized controlled trial and a preference cohort to examine the effectiveness and safety of an improved protocol of angioplasty and stenting for patients with ICAS. Methods and analysis: This study will be performed in 2 parts, a randomized controlled trial and a preference cohort. In the randomized controlled trial, ICAS patients will be randomized assigned to an angioplasty and stenting group (PTAS) and an aggressive medical treatment group (AMT), after screened by a strict selection criteria. The ICAS patients who are ineligible to the trial will be suggested for a preference to PTAS or AMT, and therefore be included in a preference cohort study. The PTAS will be performed in 3 to 5 days after enrolment, while the AMT will be initiated at the enrolment day. The primary outcome of this study is events of stroke or death within 30 days after enrolment. The secondary outcomes included the incidence of recurrent ischaemic stroke in the territory of the stenosis arteries between 30 days and 2 years postoperatively, the restenosis rate and health-related quality of life during the 2-years follow-up period. Ethics and dissemination: The protocol of this study is approved by the institutional review boards of the participating centers. The results will be disseminated to patients, clinical practitioners and policymakers through publications in journals or conference papers. It is anticipated that the results will improve current PTAS quality and guide clinical decisions for choosing treatments for ICAS patients.
Interventions
Medical treatment will be given to all the participants. Basic drugs for the treatment are aspirin and clopidogrel. The aspirin and clopidogrel will be given orally at a dose of 100mg and 75mg per day respectively for 3 months. Patients in the PTAS group will receive the same dose of the aspirin and clopidogrel 5 days before operation, and continue for 3 months after the operation. When an emergency stenting operation is needed, a loading dose of 300 mg clopidogrel will be given. Additional medi
Medical treatment will be given to all the participants. Basic drugs for the treatment are aspirin and clopidogrel. The aspirin and clopidogrel will be given orally at a dose of 100mg and 75mg per day respectively for 3 months. Patients in the PTAS group will receive the same dose of the aspirin and clopidogrel 5 days before operation, and continue for 3 months after the operation. When an emergency stenting operation is needed, a loading dose of 300 mg clopidogrel will be given. Additional medical treatment will be given to achieve a target systolic blood pressure of <140mmHg; hemoglobin A1c of <6.5% (in diabetes patients); low density lipoprotein of <2.58mmol/L. Interventions lowering the cardiovascular risk will also be used, such as lifestyle modification and smoking cessation. Participants who are allocated to PTAS will receive angioplasty and stenting within 5 days after randomization. A standard protocol of the PTAS procedure will be developed. The procedure will be performed by a cardiovascular surgeon. The participants will receive balloon-angioplasty with a balloon catheter, followed by stenting using the Wingspan stent system (manufactured by Stryker Neurovascular).
Sponsors
Fuzhou General Hospital of Nanjing Command, PLA and clinical medical college of Fujian medical university
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Patients aged from 18 to 70 years. 2. Complaints of a Symptomatic ICAS: a history of recurrent transient ischemic attacks or an ischemic stroke within 1 year owing to a stenosis from 70% to 99% in an internal carotid artery, middle cerebral artery, vertebral artery, or basilar artery. 3. A length less than or equal to 15mm of a stenosis in the target vessel and a vessel size greater than or equal to 2mm. 4. Hypoperfusion in the territory of the target vessels, which is determined by CT or MRI in 14 days before stenting. 5. CT or MRI scans show no massive cerebral infarction (beyond half of the MCA territory), intracranial hemorrhage, epidural or sub-dural hemorrhage, and intracranial brain tumor. 6. Patients who understand the purpose of the study and have provided informed consent.
Exclusion criteria
1. Not able to receive general anesthesia. 2. Not able to receive angiographic assessment. 3. A stenosis >50% in an extracranial carotid or vertebral artery on the ipsilateral side. 4. 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. 5. A high risk (leading to a stroke or death) to deliver the stent to the lesion. 6. A previous stent or angioplasty in the target lesion. 7. Progressive neurological signs within 24 hours before enrolment 8. Any haemorrhagic infarct within 14 days before enrolment 9. The presence of a cardiac source of embolus 10. Thrombolytic therapy within 24 hours before enrollment 11. Presence of intraluminal thrombus proximal to or at the target lesion 12. Myocardial infarction within previous 30 days 13. 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. 14. Known contraindications for aspirin and clopidogrel treatment. 15. An modified Rankin score greater than or equal to 3. 16. With a childbearing potential or a positive pregnancy test in 1 week before enrolment.
Outcome results
None listed