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

Primary Purpose

Vertebral Artery Stenosis

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Drug-coated balloon angioplasty
stenting angioplasty
Sponsored by
The First Affiliated Hospital of Zhengzhou University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vertebral Artery Stenosis focused on measuring Vertebral Artery Stenosis, Drug-coated balloon angioplasty, Stenting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • The First Affiliated Hospital of Zhengzhou UniversityRecruiting
  • Nanyang City Center HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Drug-coated balloon angioplasty

stenting angioplasty

Arm Description

Outcomes

Primary Outcome Measures

Restenosis

Secondary Outcome Measures

The composite of vascular death, myocardial infarction, or any stroke
The composite of vascular death, myocardial infarction, or any stroke
Death resulting from any cause
Stroke in the supply territory of the symptomatic vertebral artery

Full Information

First Posted
April 12, 2018
Last Updated
May 2, 2018
Sponsor
The First Affiliated Hospital of Zhengzhou University
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1. Study Identification

Unique Protocol Identification Number
NCT03504657
Brief Title
Drug-coated Balloon Angioplasty for Patients With Symptomatic Vertebral Artery Stenosis
Official Title
Drug-coated Balloon Angioplasty for Patients With Symptomatic Vertebral Artery Stenosis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 3, 2018 (Actual)
Primary Completion Date
May 1, 2019 (Anticipated)
Study Completion Date
April 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital of Zhengzhou University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vertebral Artery Stenosis
Keywords
Vertebral Artery Stenosis, Drug-coated balloon angioplasty, Stenting

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Drug-coated balloon angioplasty
Arm Type
Experimental
Arm Title
stenting angioplasty
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Drug-coated balloon angioplasty
Intervention Description
Angioplasty with a drug-coated angioplasty
Intervention Type
Device
Intervention Name(s)
stenting angioplasty
Intervention Description
Angioplasty with a stenting
Primary Outcome Measure Information:
Title
Restenosis
Time Frame
12 months
Secondary Outcome Measure Information:
Title
The composite of vascular death, myocardial infarction, or any stroke
Time Frame
within 30 days after the start of treatment
Title
The composite of vascular death, myocardial infarction, or any stroke
Time Frame
within 12 months after the start of treatment
Title
Death resulting from any cause
Time Frame
12 months
Title
Stroke in the supply territory of the symptomatic vertebral artery
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Serious adverse events
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chuanjie Wu, MD
Phone
008618911366882
Email
wuchuanjie8557@163.com
Facility Information:
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yajun Lian, MD
Phone
008613838367143
Email
lianyajun369@yahoo.com
Facility Name
Nanyang City Center Hospital
City
Nanyang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Changming Wen, MD

12. IPD Sharing Statement

Learn more about this trial

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

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