Treatment of Intracranial Atherosclerotic Stenosis with Drug-Eluting Stents

A Prospective, Multicenter, Registry Study to Evaluate the Safety, Efficacy, and Standardized Procedural Optimization of the Intracranial Drug-Eluting Stent System in Patients with Symptomatic Intracranial Atherosclerotic Stenosis

This study is testing if using special stents that release medication can help people with narrowed brain arteries feel better and reduce the risk of strokes or death.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Sino Medical Sciences Technology Inc. (Industry-sponsored)
• Locations: 1 site (Zhengzhou)
• Trial ID: NCT06857058 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are males and females aged 18 to 80 with symptomatic intracranial atherosclerotic stenosis suitable for stent angioplasty.

Not a fit: Patients with recent major surgeries, acute hemorrhagic strokes, or non-atherosclerotic vascular diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of stroke and improve the quality of life for patients with intracranial atherosclerotic stenosis.

How similar studies have performed: Other studies have shown promise with similar endovascular therapies, indicating potential for success in this approach.

Eligibility criteria

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 this trial is running

Zhengzhou

• 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

Conditions Intracranial Atherosclerotic Stenosis; endovascular therapy, intracranial drug-eluting stent