The primary objective of this trial is to evaluate the Safety, Efficacy, and Standardized Procedural Optimization of the Intracranial Drug-Eluting Stent System in Patients with Symptomatic Intracranial Atherosclerotic Stenosis.
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 DSA
Those who voluntarily participate in the study and sign informed consent form
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;
Single group
NOVA DES
DeviceThe NOVA stent is a sirolimus-eluting stent system designed for intracranial artery stenosis with a rapid exchangeable balloon
Stroke or death within 30 days after enrollment, plus any ischemic stroke or revascularization from the original culprit intracranial artery beyond 30 days through 12 months after procedure.
This outcome includes ischemic/hemorrhagic stroke and all-cause death within 30 days after procedure of the qualifying lesion during follow-up, or any ischemic stroke and revascularization from the original culprit symptomatic intracranial artery beyond 30 days through 12 months after procedure.
Rate of any stroke (hemorrhagic/ischemic stroke) in the target blood supply area or all-cause death at 30 days after procedure
The rate of Hemorrhagic stroke as well as symptomatic ischemic stroke and any death in the target blood supply area
Rate of any stroke (hemorrhagic/ischemic stroke) in the non-target blood supply area or all-cause death at 30 days after procedure
The rate of Hemorrhagic stroke as well as symptomatic ischemic stroke and any death in the non-target blood supply area
Rate of TIA at 30 days, 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure
TIA is a temporary blockage of blood flow to the brain with symptoms last from only a few minutes up to 24 hours
Rate of any stroke (hemorrhagic/ischemic stroke) in the target blood supply area at 3, 6 months, 1, 2, 3, 4 years and 5 years after procedure
The rate of Hemorrhagic stroke as well as symptomatic ischemic stroke in the target blood supply area
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Sino Medical Sciences Technology Inc.
Lead sponsor
The First Affiliated Hospital of Zhengzhou University
Collaborator
Tongji Hospital
Collaborator
