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

Phase 2

• Conditions: Vertebral Artery Stenosis
• Interventions: Device: Drug-coated balloon angioplasty; Device: stenting angioplasty

• Registration Number: NCT03504657
• Lead Sponsor: The First Affiliated Hospital of Zhengzhou University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-12
• Study First Submitted QC: 2018-04-12
• Study First Posted: 2018-04-20
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-02
• Study Start: 2018-05-03
• Last Update Posted: 2018-05-04
• Primary Completion: 2019-05-01
• Study Completion: 2020-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug-coated balloon angioplasty	Drug-coated balloon angioplasty	-
stenting angioplasty	stenting angioplasty	-

Primary Outcome Measures

Name	Time	Method
Restenosis	12 months

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Nanyang City Center Hospital; 🇨🇳 Nanyang, China

The First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China