Evaluating a new drug-eluting stent for treating intracranial artery stenosis in China

To Evaluate the Safety and Efficacy of the NOVA Intracranial Drug-eluting Stent System in "real World" Patients with Intracranial Atherosclerotic Stenosis: a Prospective, Multicenter, Post-marketing Registry Clinical Study (NOVA II)

This study is testing a new type of stent to see if it can safely help people in China with narrowing arteries in the brain and reduce their risk of stroke or death.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1000 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Sino Medical Sciences Technology Inc. (Industry-sponsored)
• Locations: 5 sites (Chenzhou and 4 other locations)
• Trial ID: NCT05692882 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the long-term safety and efficacy of the NOVA intracranial drug-eluting stent system in patients with symptomatic intracranial atherosclerotic stenosis. It is a prospective, multi-center, single-arm study involving approximately 1000 subjects across 50 centers in China. Participants will undergo a series of ten visits over five years, with the primary outcome focusing on the incidence of stroke or death within 30 days and any ischemic stroke or revascularization within 12 months post-operation.

Who should consider this trial

Good fit: Ideal candidates are males and females aged 18 to 80 with symptomatic intracranial arteriosclerosis stenosis and a stenosis of 70% or greater.

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

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the risk of stroke and improve outcomes for patients with intracranial artery stenosis.

How similar studies have performed: While this approach is being evaluated in this specific context, similar studies using drug-eluting stents for vascular conditions have shown promising results.

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 digital subtraction angiography (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. Target artery's supplying artery stenosis \> 50%. For example, patient with middle cerebral artery (MCA) severe stenosis (target artery) and the ipsilateral internal carotid artery (ICA) stenosis \> 50% should be excluded; patient with basilar artery (BA) severe stenosis (target artery) and the dominant vertical artery (VA) 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

Chenzhou and 4 other locations

• First People's Hospital of Chenzhou — Chenzhou, China (Recruiting)
• Ganzhou People's Hospital — Ganzhou, China (Recruiting)
• Jinhua Municipal Central Hospital — Jinhua, China (Recruiting)
• The First Affiliated Hospital of Ningbo University — Ningbo, China (Recruiting)
• Shanxi Cardiovascular Hospital — Shanxi, China (Recruiting)

Study contacts

• Principal investigator: Zhongrong Zhongrong — Beijing Tiantan Hospital
• Study coordinator: Zhongrong Miao, MD

Conditions Intracranial Arteriosclerosis; Stenosis Artery; Drug-Eluting Stents; Intracranial Artery Stenosis; endovascular therapy; intracranial drug-eluting stent; symptomatic intracranial artery stenosis