Angioplasty and Stenting for Patients With Symptomatic Intracranial Atherosclerosis

T

The 476th Hospital of People's Liberation Army

Status and phase

Unknown
Phase 3

Conditions

Intracranial Atherosclerosis

Treatments

Procedure: Percutaneous transluminal angioplasty and stenting
Drug: Aspirin plus clopidogrel

Study type

Interventional

Funder types

Other

Identifiers

NCT02689037
12MA100

Details and patient eligibility

About

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.

Enrollment

394 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

394 participants in 2 patient groups

stenting+medical treatment
Experimental group
Description:
Patients in PTAS+MT group will receive Percutaneous transluminal angioplasty and stenting and medical treatment (aspirin 100mg daily and clopidogrel 75mg daily)
Treatment:
Drug: Aspirin plus clopidogrel
Procedure: Percutaneous transluminal angioplasty and stenting
Aspirin plus clopidogrel
Active Comparator group
Description:
Patients in aspirin plus clopidogrel group will receive aspirin 100mg daily and clopidogrel 75mg daily for 90 days.
Treatment:
Drug: Aspirin plus clopidogrel

Trial contacts and locations

0

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Central trial contact

Xiao-Ping Cui, MD

Data sourced from clinicaltrials.gov

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