CompletedNot Applicable

AcoArt sICAS: DCB in the Treatment of Symptomatic Intracranial Atherosclerotic Stenosis

China180 participantsStarted 2021-06-04

Plain-language summary

The purpose of the RCT trial is to determine whether DCB is not inferior to stent in treating intracranial 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: * 18 to 80 years of age; * Patients with symptomatic intracranial atherosclerotic stenosis; * Patients with intracranial arterial de novo stenosis confirmed by digital subtraction angiography (DSA); * Confirmed by DSA，the diameter of the target vessel is between 2.5mm-4.5mm ; according to WASID method, the degree of stenosis of the target lesion is 70%-99%; * Baseline mRS score ≤2; * Voluntarily participate in this study and sign the informed consent form. Exclusion Criteria: * Patients with stroke within 2 weeks before procedure; * Patients with stroke caused by perforating artery occlusion; * Any history of brain parenchymal or other intracranial subarachnoid, subdural or extradural hemorrhage in the past 30 days; * Those who have received thrombolysis within 24 hours before procedure; * Deterioration of neurological function within 24 hours before procedure (defined as NIHSS score increased by ≥ 4 points over the baseline); * The vascular path showed in angiography is so tortuous that it is difficult to advance catheters to the target lesion or retrieve; * Lesions that investigators believe are not suitable for stenting; * Patients with thrombus in target vessel; * In addition to the target lesion, there are still other de novo lesion or ISR lesion with more than 70% diameter stenosis in intracranial arteries that need to be treated at the same time; * After endovascular treatment of the target lesion, there is still a stenosis of more than 50% in th…

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

Primary efficacy endpoint: Angiographic restenosis of the target lesion

Timeframe: 6 months post-procedure

Primary safety endpoint: Target vessel stroke or death event

Timeframe: within 30 days post-procedure

Trial details

NCT IDNCT04631055

SponsorAcotec Scientific Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-04-10

View on ClinicalTrials.gov More Intracranial Atherosclerosis trials

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.