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

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 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.

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 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 it's running

• 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
• Email: zhongrongm@163.com
• Phone: +8613601243293

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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.