Treatment of Intracranial Atherosclerotic Stenosis with Drug-Eluting Stents

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and efficacy of a standardized procedure using drug-eluting stents for patients with symptomatic intracranial atherosclerotic stenosis. It is a prospective, multi-center study aiming to enroll 300 subjects who meet specific inclusion criteria. Participants will undergo a series of ten visits for preoperative screening and follow-up assessments over five years to monitor outcomes such as stroke or death within 30 days and any subsequent ischemic events. The study seeks to optimize procedural techniques and improve patient outcomes in this condition.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Males or females between 18 and 80 years of age
2. Symptomatic intracranial arteriosclerosis stenosis with reference diameter 2.25-4.00mm
3. Intracranial artery stenosis ( ≥70%) conformed by DSA
4. Those who voluntarily participate in the study and sign informed consent form

Exclusion Criteria:

1. Those who have surgery within previous 30 days or plan to perform major surgery in the next 90 days (surgery grade 3 and above);
2. Subjects of acute hemorrhagic stroke within 3 months;
3. The baseline mRS of disabling stroke is more than 3;
4. The target vessel is severely calcified and closely related to stenosis;
5. Non-atherosclerotic diseases (e.g. arterial dissection, Moya Moya disease, vascular inflammatory lesions caused by infection, autoimmune diseases, post-irradiation, postpartum status; developmental or genetic abnormalities such as fibromuscular dysplasia, sickle cell anemia, suspected vasospasm);
6. It is suspected that the ischemic event is due to embolism or arterial embolism from the extracranial segment (including ipsilateral chest or neck vascular occlusive disease) or potential cardiogenic embolism (e.g. atrial fibrillation, mitral stenosis, patent foramen ovale, left ventricular thrombus, myocardial infarction within 6 weeks, etc.);
7. The presence of a \>50% stenosis in the main blood supply artery of the target vessel. For example, when the lesion is located in the middle cerebral artery, the ipsilateral internal carotid artery stenosis by over 50% should be excluded; when the lesion is located in the basilar artery, the dominant side vertebral artery stenosis \>50% should be excluded;
8. There are intracranial tumors, or intracranial arteriovenous malformations;
9. Those who are allergic to heparin, aspirin, clopidogrel, contrast agents, anesthetics, and stent components;
10. Pregnant and lactating women
11. Those who are unable to complete follow-up because of mental illness, cognitive or emotional disorders;
12. Inapplicable for this study at the investigators' viewpoints.

Where it's running

• The first affiliated hospital of zhengzhou university
  Zhengzhou, China Recruiting

Study contacts

• Principal investigator: Sheng Guan — The First Affiliated Hospital of Zhengzhou University
• Study coordinator: Xiaoyan Yu
• Email: yuxiaoyan@sinomed.com
• Phone: 18614030565

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Photon-counting CT to check intracranial stents

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• Pemafibrate for Symptomatic ICAS

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.