Drug-coated Balloon Angioplasty for Patients With Symptomatic Vertebral Artery Stenosis
1 other identifier
interventional
150
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2018
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2018
CompletedFirst Posted
Study publicly available on registry
April 20, 2018
CompletedStudy Start
First participant enrolled
May 3, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2020
CompletedMay 4, 2018
May 1, 2018
12 months
April 12, 2018
May 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Restenosis
12 months
Secondary Outcomes (4)
The composite of vascular death, myocardial infarction, or any stroke
within 30 days after the start of treatment
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
Other Outcomes (1)
Serious adverse events
30 days
Study Arms (2)
Drug-coated balloon angioplasty
EXPERIMENTALstenting angioplasty
ACTIVE COMPARATORInterventions
Angioplasty with a drug-coated angioplasty
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000, China
Nanyang City Center Hospital
Nanyang, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
April 12, 2018
First Posted
April 20, 2018
Study Start
May 3, 2018
Primary Completion
May 1, 2019
Study Completion
April 30, 2020
Last Updated
May 4, 2018
Record last verified: 2018-05