NCT06857045撤回不适用
A Prospective, Multicenter, Open-label, Randomized Controlled Trial of 3-month Versus 6-month Dual Antiplatelet Therapy After Implantation of NOVA Intracranial Sirolimus-eluting Stent System
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 478
- 试验地点
- 1
- 主要终点
- Any stroke, death and major bleeding
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Subjects who voluntarily participate in the study and sign informed consent form.
排除标准
- •Subjects 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.
- •Disabling stroke with a baseline mRS score ≥
- •Lesion artery with severe calcification and close neighbour 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).
- •The ischaemic event that is highly suspected to be due to vascular embolism from an extracranial arterial segment such as ipsilateral neck/chest arterial occlusion) or cardio embolism such as atrial fibrillation, mitral stenosis, left ventricular thrombus, patent foramen ovale, myocardial infarction within 6 weeks, etc.
- •More than 50% stenosis of the supplying artery of the lesion artery: 1) MCA severe stenosis (lesion artery) with more than 50% stenosis of ipsilateral ICA (supplying artery). 2) Basilar artery severe stenosis (lesion artery) with more than 50% stenosis of dominant VA (supplying artery) stenosis.
- •Accompanied by intracranial tumours or intracranial arteriovenous malformations.
- •The patient who is allergy response to heparin, aspirin, clopidogrel, rapamycin, contrast agents, anaesthetics, or drug eluted stent components.
- •Women who are pregnant or lactating.
- •Due to cognitive or emotional disorders or mental illness, the patient who cannot finish the follow-up.
- •Investigators consider the patient who is not suitable for enrolling in the present trial.
结局指标
主要结局
Any stroke, death and major bleeding
时间窗: 1 year after operation
Major bleeding was define as intracranial or systemic bleeding requiring hospitalization, blood transfusion or surgery.
次要结局
- 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.(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(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(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(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(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(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(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(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(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(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)(1, 2, 3, 4 years and 5 years after operation)
- Rate of Device defect(within 5 years of whole trial)
- Rate of bleeding events at 1 years after operation(1 year after operation)
研究者
研究点 (1)
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