Angioplasty and Stenting versus medical treatment in patients with symptomatic intracranial artery stenosis: a randomized controlled trial and a preference cohort

Phase 2

Recruiting

• Conditions: symptomatic intracranial artery stenosis; Neurological - Other neurological disorders; Cardiovascular - Other cardiovascular diseases; Surgery - Other surgery

• Registration Number: ACTRN12615000759594
• Lead Sponsor: Fuzhou General Hospital of Nanjing Command, PLA and clinical medical college of Fujian medical university

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 198

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is a composite outcome, which is events of stroke or death assessed according to patient medical records.[within 30 days after enrolment]

Secondary Outcome Measures

Name	Time	Method
The incidence of recurrent ischaemic stroke in the territory of the stenosis arteries is assessed by CT or MRI images.[between 30 days and 2 years postoperatively];The restenosis rate is assessed with the Magnetic Resonance Angiography (MRA) scan in the territory of the stenosis arteries.[during the 2 years follow-up after surgery];The health-related quality of life is assessed by the MOS 36-item short-form health survey (SF-36).[1 and 2 years after surgery]