Drug-Eluting Stents: The NOVA stent is a sirolimus-eluting stent system designed for intracranial artery stenosis with a rapid exchangeable balloon
Study summary
The primary objective of this trial is to evaluate the long-term safety and efficacy of the NOVA intracranial drug-eluting stent system in "real world" patients with intracranial atherosclerotic stenosis.
Eligibility
Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
stroke or death within 30 days or any ischemic stroke or revascularization from the original culprit intracranial artery beyond 30 days through 12 months after operation. — 1 year after operation The primary outcome was a composite of ischemic/hemorrhagic stroke and all-cause death within 30 days, or any ischemic stroke and revascularization from the original culprit intracranial artery beyond 30 days through 12 months after enrollment.
Trial sites (5)
Facility
City
Region
Status
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
More Sino Medical Sciences Technology Inc. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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