Drug Coated Balloon Versus Stenting in Patients With Symptomatic Vertebral Artery Stenosis：an Obs… (NCT03311360) | Clinical Trial Compass
CompletedNot Applicable
Drug Coated Balloon Versus Stenting in Patients With Symptomatic Vertebral Artery Stenosis：an Observational Clinical Study
China95 participantsStarted 2018-01-01
Plain-language summary
There are two arms in our trial, DCB group, BMS group.The investigators are going to investigate the safety and efficacy of all groups at 6 months and 12 months.
Who can participate
Age range
18 Years – 80 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
. aged between 18 and 80 years old;
. TIA or non-disabling ischaemic stroke of the posterior circulation;
. symptoms occurred in the 14 days and could not be relieved after 2 months of regular medication
. stenosis of the vertebral artery of 50% or greater, diagnosed by both CT angiography or angiography;
. NIHSS≤ 6;
. score on the modified Rankin scale ≤ 3.
Exclusion criteria
. Active bleeding or coagulation disorders or severe renal/liver impairment
. allergy to iodinated contrast agent or related medicines;
. acute stroke in 3 weeks
. more than 1 stenosis at the target vessel or Distal vascular dysplasia (diameter≤3mm)
. a potential cause of stenosis other than atherosclerosis
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
1
Incidence of vascular death,non-fatal myocardial and non-fatal stroke in 12 months
Timeframe: 12 months
Trial details
NCT IDNCT03311360
SponsorChinese Society of Interventional Radiology