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

May 2, 2018 updated by: Chuanjie Wu, The First Affiliated Hospital of Zhengzhou University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Nanyang, China
        • Recruiting
        • Nanyang City Center Hospital
        • Contact:
          • Changming Wen, MD
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Recruiting
        • The First Affiliated Hospital of Zhengzhou University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Drug-coated balloon angioplasty
Device: Drug-coated balloon angioplasty
Angioplasty with a drug-coated angioplasty
ACTIVE_COMPARATOR: stenting angioplasty
Device: stenting angioplasty
Angioplasty with a stenting

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Restenosis
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
The composite of vascular death, myocardial infarction, or any stroke
Time Frame: within 30 days after the start of treatment
within 30 days after the start of treatment
The composite of vascular death, myocardial infarction, or any stroke
Time Frame: within 12 months after the start of treatment
within 12 months after the start of treatment
Death resulting from any cause
Time Frame: 12 months
12 months
Stroke in the supply territory of the symptomatic vertebral artery
Time Frame: 12 months
12 months

Other Outcome Measures

Outcome Measure
Time Frame
Serious adverse events
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Zhengzhou University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 3, 2018

Primary Completion (ANTICIPATED)

May 1, 2019

Study Completion (ANTICIPATED)

April 30, 2020

Study Registration Dates

First Submitted

April 12, 2018

First Submitted That Met QC Criteria

April 12, 2018

First Posted (ACTUAL)

April 20, 2018

Study Record Updates

Last Update Posted (ACTUAL)

May 4, 2018

Last Update Submitted That Met QC Criteria

May 2, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FAHZU-2018-006

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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