CClinicalTrials.gg
Status unknownNCT03504657Updated May 4, 2018

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

A Phase 2 interventional study of Drug-coated balloon angioplasty and stenting angioplasty in Vertebral Artery Stenosis, sponsored by The First Affiliated Hospital of Zhengzhou University. Status unknown at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-04.

Sponsored by The First Affiliated Hospital of Zhengzhou University · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Vertebral Artery Stenosis

Keywords

  • Vertebral Artery Stenosis
  • Drug-coated balloon angioplasty
  • Stenting
03

In context

Vertebrobasilar Insufficiency

20 studies on the registry are indexed under Vertebrobasilar Insufficiency; 8 are open to participants now.

This study's planned enrollment of 150 is above the median of 90 across 14 interventional studies indexed under Vertebrobasilar Insufficiency.

Browse Vertebrobasilar Insufficiency studies →

Lead sponsor

The First Affiliated Hospital of Zhengzhou University is the lead sponsor of 123 studies on the registry; 72 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Outcomes assessor)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    Drug-coated balloon angioplasty

    Device: Drug-coated balloon angioplasty

  • Active comparator
    stenting angioplasty

    Device: stenting angioplasty

Interventions

  • DeviceDrug-coated balloon angioplasty

    Angioplasty with a drug-coated angioplasty

  • Devicestenting angioplasty

    Angioplasty with a stenting

06

What researchers measure

Primary outcomes

  1. Restenosis

    Time frame: 12 months

Secondary outcomes

  1. The composite of vascular death, myocardial infarction, or any stroke

    Time frame: within 30 days after the start of treatment

  2. The composite of vascular death, myocardial infarction, or any stroke

    Time frame: within 12 months after the start of treatment

  3. Death resulting from any cause

    Time frame: 12 months

  4. Stroke in the supply territory of the symptomatic vertebral artery

    Time frame: 12 months

Other outcomes

  1. Serious adverse events

    Time frame: 30 days

07

Study locations

2 of 2 sites recruiting
  • The First Affiliated Hospital of Zhengzhou University
    Zhengzhou, Henan 450000, China
    Recruiting
  • Nanyang City Center Hospital
    Nanyang, China
    • Changming Wen, MD · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03504657
Lead sponsor
The First Affiliated Hospital of Zhengzhou University
Responsible party
Chuanjie Wu (MD, The First Affiliated Hospital of Zhengzhou University) — Principal investigator
First posted
Apr 20, 2018
Start date
May 3, 2018
Primary completion
May 1, 2019 (estimated)
Completion
Apr 30, 2020 (estimated)
Last update
May 4, 2018

Study contacts

Chuanjie Wu, MD
Contact
wuchuanjie8557@163.com
008618911366882

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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