An interventional study of NOVA intracranial sirolimus-eluting stent system in Intracranial Arteriosclerosis, Intracranial Artery Stenosis and Drug-Eluting Stents, sponsored by Sino Medical Sciences Technology Inc.. Withdrawn at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-11-25.
Sponsored by Sino Medical Sciences Technology Inc. · Not applicable, Interventional, and Treatment
This study is a prospective, multicenter, open-label, randomized controlled clinical trial, aims to assess the clinical non-inferiority of 3 months (short-term) vs 6 months (long-term) of Dual Anti-Platelet Therapy (DAPT) in patients after implanted NOVA intracranial sirolimus-eluting stent system. All participants met the inclusion criteria will be 1:1 randomized to 3 months or 12 months of DAPT at index procedure.
This study will recruit 478 subjects with intracranial atherosclerotic stenosis (ICAS) in China. All participants met the inclusion criteria will be 1:1 randomized to 3 months or 6 months of DAPT after implanting NOVA stent. Clinical follow-up will be carried out at 30 days, 3 months, 6 months, 12 months, 1 year, 2 years, 3 years, 4 years and 5 years after index procedure. The primary endpoint is the composite endpoint of any stroke, death and major bleeding (intracranial or systemic bleeding requiring hospitalization, blood transfusion or surgery) at 1 year.
93 studies on the registry are indexed under Intracranial Arteriosclerosis; 41 are open to participants now.
Browse Intracranial Arteriosclerosis studies →Sino Medical Sciences Technology Inc. is the lead sponsor of 13 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
After implantation of NOVA stents, all subjects in intervention group will be given dual anti-platelet therapy (DAPT) including aspirin and thienopyridines (clopidogrel or ticagrelor) for 3 months.
Device: NOVA intracranial sirolimus-eluting stent system
After implantation of Firehawk coronary stents, all subjects in control group will be given dual anti-platelet therapy (DAPT) including aspirin and thienopyridines (clopidogrel or ticagrelor) for 6 months.
Device: NOVA intracranial sirolimus-eluting stent system
The NOVA stent is a sirolimus-eluting stent system designed for intracranial artery stenosis with a rapid exchangeable balloon.
Any stroke, death and major bleeding
Major bleeding was define as intracranial or systemic bleeding requiring hospitalization, blood transfusion or surgery.
Time frame: 1 year after operation
Any stroke or death within 30 days or any ischemic stroke from the original culprit intracranial artery beyond 30 days through 12 months after operation.
The primary outcome was a composite of ischemic/hemorrhagic stroke and all-cause death within 30 days, or any ischemic stroke from the original culprit intracranial artery beyond 30 days through 12 months after operation.
Time frame: 1 year after operation
Rate of any stroke (hemorrhagic/ischemic stroke) in the target blood supply area or all-cause death at 30 days after operation
The rate of Hemorrhagic stroke as well as symptomatic ischemic stroke and any death in the target blood supply area.
Time frame: 30 days after operation
Rate of any stroke (hemorrhagic/ischemic stroke) in the non-target blood supply area or all-cause death at 30 days after operation
The rate of Hemorrhagic stroke as well as symptomatic ischemic stroke and any death in the non-target blood supply area.
Time frame: 30 days after operation
Rate of TIA at 30 days, 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after operation
Transient ischemic attack (TIA) is a temporary blockage of blood flow to the brain with symptoms last from only a few minutes up to 24 hours.
Time frame: 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after operation
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 operation
The rate of Hemorrhagic stroke as well as symptomatic ischemic stroke in the target blood supply area.
Time frame: 3, 6 months, 1, 2, 3, 4 years and 5 years after operation
Rate of any stroke (hemorrhagic/ischemic stroke) in the non-target blood supply area at 3, 6 months, 1, 2, 3, 4 years and 5 years after operation
The rate of Hemorrhagic stroke as well as symptomatic ischemic stroke in the non-target blood supply area.
Time frame: 3, 6 months, 1, 2, 3, 4 years and 5 years after operation
Rate of death (vascular/ non-vascular death) at 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after operation
The cause of death was classified as vascular or nonvascular and based on information obtained from the family, medical records, and death certificates. Vascular death included death due to stroke, MI, heart failure, pulmonary embolus, cardiac arrhythmia, or other vascular cause.
Time frame: 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after operation
Rate of symptomatic ISR and Revascularization at 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after operation
symptomatic ISR is defined as ISR associated with an ischemic event in the territory. Revascularization is the restoration or improvement of blood supply, and included surgical operation, endovascularization is the restoration or improvement of blood supply, and included surgical operation, endovascular procedures, etc.
Time frame: 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after operation
Rate of modified Rankin Scale (mRS) at 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after operation
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 with "0" being perfect health without symptoms to "6" being death.
Time frame: 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after operation
EQ-5D score at 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after operation
A health state defined by the descriptive EQ-5D system can be described by a five-digit number, each digit indicating the score of the corresponding dimension. For the description component a subject self-rates their health in terms of five dimensions; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using either a three-level or a five-level scale.
Time frame: 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after operation
Rate of in-stent restenosis at 1, 2, 3, 4 years and 5 years after operation (Optional)
Patients with ≥50% stenosis of the vessel.
Time frame: 1, 2, 3, 4 years and 5 years after operation
Rate of Device defect
Device defects refer to the unreasonable risks that may endanger human health and life safety during the normal use of medical devices in the course of clinical trials, such as label errors, quality problems, failures, etc.
Time frame: within 5 years of whole trial
Rate of bleeding events at 1 years after operation
Bleeding was defined according to Bleeding Academic Research Consortium
Time frame: 1 year after operation
This study is withdrawn, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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