To Evaluate the Safety and Efficacy of the NOVA Intracranial Drug-eluting Stent System in "real World" Patients with Intracranial Atherosclerotic Stenosis: a Prospective, Multicenter, Post-marketing Registry Clinical Study (NOVA II)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Intracranial Arteriosclerosis
- Sponsor
- Sino Medical Sciences Technology Inc.
- Enrollment
- 1000
- Locations
- 5
- Primary Endpoint
- stroke or death within 30 days or any ischemic stroke or revascularization from the original culprit intracranial artery beyond 30 days through 12 months after operation.
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Detailed Description
The investigation is a prospective, multi-center, single arm clinical study. The trial is anticipated to last from December 2022 to December 2030 with 1000 subjects recruited in around 50 Chinese centers. The population for this study is subjects with intracranial atherosclerotic stenosis who are suitable candidates for stent angioplasty. Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be enrolled after they signed the informed consent form. The study consists of ten visits including preoperative screening, operation date, 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years. The primary outcome was a composite of stroke or death within 30 days or any ischemic stroke or revascularization from the original culprit intracranial artery beyond 30 days through 12 months after operation.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 digital subtraction angiography (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 middle cerebral artery (MCA) severe stenosis (target artery) and the ipsilateral internal carotid artery (ICA) stenosis \> 50% should be excluded; patient with basilar artery (BA) severe stenosis (target artery) and the dominant vertical artery (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 women
Outcomes
Primary Outcomes
stroke or death within 30 days or any ischemic stroke or revascularization from the original culprit intracranial artery beyond 30 days through 12 months after operation.
Time Frame: 1 year after operation
The primary outcome was a composite of ischemic/hemorrhagic stroke and all-cause death within 30 days, or any ischemic stroke and revascularization from the original culprit intracranial artery beyond 30 days through 12 months after enrollment.
Secondary Outcomes
- Rate of bleeding events at 1 years 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 transient ischemic attack 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 symptomatic in-stent restenosis (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 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 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)
- EuroQol-5D (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)