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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03504657

Enrollment

150

Registered

2018-04-20

Start date

2018-05-03

Completion date

2020-04-30

Last updated

2018-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vertebral Artery Stenosis

Keywords

Vertebral Artery Stenosis, Drug-coated balloon angioplasty, Stenting

Brief summary

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.

Interventions

DEVICEDrug-coated balloon angioplasty

Angioplasty with a drug-coated angioplasty

DEVICEstenting angioplasty

Angioplasty with a stenting

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Restenosis	12 months

Secondary

Measure	Time frame
The composite of vascular death, myocardial infarction, or any stroke	within 30 days after the start of treatment
Death resulting from any cause	12 months
Stroke in the supply territory of the symptomatic vertebral artery	12 months

Other

Measure	Time frame
Serious adverse events	30 days

Countries

China

Contacts

Primary ContactChuanjie Wu, MD

wuchuanjie8557@163.com008618911366882

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026