Drug-coated Balloon Angioplasty for Patients With Symptomatic Vertebral Artery Stenosis
NCT ID: NCT03504657
Last Updated: 2018-05-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
150 participants
INTERVENTIONAL
2018-05-03
2020-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Drug-coated balloon angioplasty
Drug-coated balloon angioplasty
Angioplasty with a drug-coated angioplasty
stenting angioplasty
stenting angioplasty
Angioplasty with a stenting
Interventions
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Drug-coated balloon angioplasty
Angioplasty with a drug-coated angioplasty
stenting angioplasty
Angioplasty with a stenting
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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The First Affiliated Hospital of Zhengzhou University
OTHER
Responsible Party
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Chuanjie Wu
MD
Locations
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The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Nanyang City Center Hospital
Nanyang, , China
Countries
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Central Contacts
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Facility Contacts
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Changming Wen, MD
Role: primary
Other Identifiers
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FAHZU-2018-006
Identifier Type: -
Identifier Source: org_study_id
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