UnknownPhase 2

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

China150 participantsStarted 2018-05-03

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Restenosis

Timeframe: 12 months

Trial details

NCT IDNCT03504657

SponsorThe First Affiliated Hospital of Zhengzhou University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-05-01

Contact for this trial

Chuanjie Wu, MD

008618911366882 wuchuanjie8557@163.com

View on ClinicalTrials.gov More Vertebral Artery Stenosis trials