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

NCT ID: NCT03504657

Last Updated: 2018-05-04

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-03

Study Completion Date

2020-04-30

Brief Summary

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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

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Conditions

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Vertebral Artery Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Drug-coated balloon angioplasty

Group Type EXPERIMENTAL

Drug-coated balloon angioplasty

Intervention Type DEVICE

Angioplasty with a drug-coated angioplasty

stenting angioplasty

Group Type ACTIVE_COMPARATOR

stenting angioplasty

Intervention Type DEVICE

Angioplasty with a stenting

Interventions

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Drug-coated balloon angioplasty

Angioplasty with a drug-coated angioplasty

Intervention Type DEVICE

stenting angioplasty

Angioplasty with a stenting

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role lead

Responsible Party

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Chuanjie Wu

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status RECRUITING

Nanyang City Center Hospital

Nanyang, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Chuanjie Wu, MD

Role: CONTACT

008618911366882

Facility Contacts

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Yajun Lian, MD

Role: primary

008613838367143

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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