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Recruiting NCT05692882

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

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Trial Parameters

Condition Intracranial Arteriosclerosis
Sponsor Sino Medical Sciences Technology Inc.
Study Type INTERVENTIONAL
Phase N/A
Enrollment 1,000
Sex ALL
Min Age 18 Years
Max Age 85 Years
Start Date 2023-11-16
Completion 2025-12-30
Interventions
Drug-Eluting Stents

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Brief 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: 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 th

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