A Registry Study of Intracranial Atherosclerotic Stenosis Treatment by Intracranial Drug-eluting Stenting in China

Recruiting now · Not applicable

Conditions studied: Intracranial Arteriosclerosis, Stenosis Artery, Drug-Eluting Stents, Intracranial Artery Stenosis

In brief

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.

Key facts

Study ID

NCT05692882

Run by

Sino Medical Sciences Technology Inc.

People needed

1000

Starts

2023-11-16

Expected to finish

2029-12-30

Last updated by the study team

2025-04-01

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Those who have surgery within previous 30 days or plan to perform major surgery in the next 90 days (surgery grade 3 and above);
• Subjects of acute hemorrhagic stroke within 3 months;
• The baseline mRS of disabling stroke is more than 3;
• The target vessel is severely calcified and closely related to stenosis;
• 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);
• 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.);
• 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;
• There are intracranial tumors, or intracranial arteriovenous malformations;
• Those who are allergic to heparin, aspirin, clopidogrel, contrast agents, anesthetics, and stent components;
• Pregnant and lactating women
• Those who are unable to complete follow-up because of mental illness, cognitive or emotional disorders;
• Inapplicable for this study at the investigators' viewpoints.

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.