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NCT05692882
A Registry Study of Intracranial Atherosclerotic Stenosis Treatment by Intracranial Drug-eluting Stenting in China
Conditions: Intracranial Arteriosclerosis, Stenosis Artery, Drug-Eluting Stents, Intracranial Artery Stenosis
Sex: All
Ages: 18 Years – 85 Years
Phase: NA
Enrollment: 1000
Sponsor: Sinomed Neurovita Technology Inc.
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 Criteria
Inclusion Criteria:Males or females between 35 and 80 years of age;Symptomatic intracranial arteriosclerosis stenosis with reference diameter 2.25-4.00mm;intracranial artery stenosis ( ≥70%) conformed by DSA;Those who voluntarily participate in the study and sign informed consent form.Exclusion Criteria: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 MCA severe stenosis (target artery) and the ipsilateral ICA stenosis > 50% should be excluded; patient with BA severe stenosis (target artery) and the dominant 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 womenThose who are unable to complete follow-up because of mental illness, cognitive or emotional disorders;Inapplicable for this study at the investigators' viewpoints.
Source: ClinicalTrials.gov (NCT05692882). StuddyBuddy aggregates publicly available trial information.