Early Stent-assisted Angioplasty in Symptomatic Intracranial Stenosis (ESASIS)

Last Updated on 6 October, 2017

Principal Investigator

Professor Thomas Leung
Professor Simon Yu

Study Rationale and Objective

Symptomatic intracranial stenosis portends a high risk of recurrent stroke, notably within the first year of the index ischemic stroke, despite medical therapy. Early adjunctive stenting of the culprit intracranial stenosis may reduce the stroke risk by restoring cerebral perfusion and diminishing artery-to-artery thrombo-embolism.

The objective of this study is to investigate the safety and efficacy of early stenting in patients with symptomatic intracranial stenosis (within 6 weeks from the index ischemic stroke) vs medical therapy

Study Design

Prospective, randomized, single-center trial

Patient Population

Patients with ischemic stroke attributable to a high-grade (70-99%) intracranial stenosis will be enrolled.

Sample size estimation

100 patients in each arm (Type 1 error 5%; statistical power 80%; adverse outcome in the control group 20%; adverse outcome in the study group 5%)

Eligibility criteria

Inclusion Criteria:

  1. Patient is at least 18 to 80 years of age, inclusive.
  2. Acute ischemic stroke (within 3 weeks) attributable to a ≥70% stenosis of an intracranial artery (i.e. C6/7 internal carotid artery, M1 middle cerebral artery, V4 vertebral artery, or basilar artery) evidenced in DSA.
  3. The target intracranial artery has a normal diameter of 2.00 mm to 4.5 mm; and the target area of stenosis is less than or equal to 14 mm in length
  4. A modified Rankin score of <3
  5. Patient understands the purpose and requirements of the study, can make him/herself understood, and has provided informed consent

Exclusion Criteria:

  1. Any medical condition that would not allow the patient to adhere to the protocol or complete the study
  2. Patients for whom the required medications for the study are contra-indicated.
  3. Brain infarct within previous 30 days of enrollment that is of sufficient size (> 5 cms) to be at risk of hemorrhagic conversion during or after stenting
  4. Active peptic ulcer disease, history of intracerebral (parenchymal) hemorrhage, major systemic hemorrhage within 30 days, active bleeding diathesis, platelets1.5, clotting factor abnormality that increases the risk of bleeding, alcohol or substance abuse, uncontrolled severe hypertension (systolic pressure > 180 mm Hg or diastolic pressure > 115mm Hg), severe liver impairment (SGOT > 3 x normal, cirrhosis), creatinine > 3.0 (unless on dialysis)
  5. Stroke etiology other than intracranial atherosclerosis, such as cardioembolism (atrial fibrillation, prosthetic heart valve, myocardial infarction within 6 weeks, mitral stenosis, intracardiac clot, bacterial endocarditis, or ventricular aneurysm), or a tandem high-grade (>70%) proximal extra-cranial carotid or vertebral stenosis.
  6. Non-atherosclerotic intracranial stenosis, such as MoyaMoya disease, fibromuscular dysplasia, vasculitis or dissection.
  7. Women who are pregnant or intend to become pregnant during the study.
  8. Known intracranial tumor, arterio-venous malformation or aneurysm.
  9. Life expectancy less than one year.
  10. Previous intracranial stenting of the target artery.
  11. Major surgical operation within the past 30 days.