DEB for Symptomatic Intracranial Atherosclerosis Stenosis (NCT04821726) | Clinical Trial Compass
UnknownNot Applicable
DEB for Symptomatic Intracranial Atherosclerosis Stenosis
China155 participantsStarted 2021-06-21
Plain-language summary
A prospective, multi-center, single-arm study to evaluate the safety and efficacy of drug eluting balloon catheter for the treatment of patients with symptomatic intracranial atherosclerotic stenosis.
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
. Age 18 to 80 years old;
. Symptomatic intracranial artery stenosis, the degree of intracranial diseased artery vascular stenosis measured under cerebral angiography between 70\~99% (WASID method);
. Symptoms are still recurrent after conservative medication (symptoms refer to stroke and transient ischemic episodes of the brain),or intracranial artery stenosis combined with remote low perfusion performance (rCBF or rCBV abnormalities) in patients.
. The stenotic vessels are located in the internal carotid artery (intracranial segment), middle cerebral artery, vertebral artery (intracranial segment), basilar artery, distal blood vessels are normal;
. Only one lesion needed to be treated;
. The intracranial artery needed to be treated l art mm in diameter;
. Pre-expansion must be satisfied: forward blood flow TICI 3 level, pre-expanded guide wire retention, observation for 5 minutes, residual stenosis is still ≤50%; without blood limited dissection;
. Patients have at least 1 porridge plaque risk factor, including past or existing hypertension, diabetes, hyperlipidemia, smoking;
Exclusion criteria
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.