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

Zhengzhou University

Status and phase

Unknown

Phase 2

Conditions

Vertebral Artery Stenosis

Treatments

Device: Drug-coated balloon angioplasty

Device: stenting angioplasty

Study type

Interventional

Funder types

Other

Identifiers

NCT03504657

FAHZU-2018-006

Details and patient eligibility

About

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.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.