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

Z

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

150 participants in 2 patient groups

Drug-coated balloon angioplasty
Experimental group
Treatment:
Device: Drug-coated balloon angioplasty
stenting angioplasty
Active Comparator group
Treatment:
Device: stenting angioplasty

Trial contacts and locations

2

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Central trial contact

Chuanjie Wu, MD

Data sourced from clinicaltrials.gov

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