Drug-coated Balloon Angioplasty for Patients With Symptomatic Vertebral Artery Stenosis

Drug-coated Balloon Angioplasty for Patients With Symptomatic Vertebral Artery Stenosis

Posterior circulation stroke accounts for 20% of ischemic stroke. A quarter occurs in patients with stenosis in the vertebral and/or basilar arteries. Vertebral artery stenosis can be treated with stenting. However, in-stent restenosis rate have been reported as high as more than 30%, which may reduce the effect of stent therapy. Drug-coated balloon has shown good results in controlling neointimal hyperplasia in the femoral and popliteal arteries.

Inclusion Criteria:

• Age 18 years or older
• Patients presenting with posterior circulation transient ischemic attack or nondisabling stroke in the previous 6 months
• Vertebral artery origin stenosis resulting from presumed atheromatous disease with stenosis ≥50%
• Lesion length of the stenosis >5mm.
• Angioplasty can be performed within two weeks after randomization
• Female subjects of childbearing potential have a negative pregnancy test.
• Signed informed consent prior to entering study

Exclusion Criteria:

• Potential cause of TIA or minor stroke other than stenosis in a vertebral artery (e.g. atrial fibrillation)
• Life expectancy shorter than 2 years
• Vertebral artery stenosis caused by dissection
• Vertebral stenting felt to be technically impracticable
• Previous stenting in randomized artery
• Pre-morbid modified Rankin scale score of greater than 3
• Currently participating or previously participated in any investigational drug or device study within 6 months.