Drug-Eluting Stents, Intracranial Arteriosclerosis, Intracranial Artery Stenosis
Conditions
Keywords
intracranial drug-eluting stent, symptomatic intracranial artery stenosis (sICAS)
Brief summary
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.
Detailed description
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.
Interventions
DEVICENOVA intracranial sirolimus-eluting stent system
The NOVA stent is a sirolimus-eluting stent system designed for intracranial artery stenosis with a rapid exchangeable balloon.
Sponsors
Sino Medical Sciences Technology Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Males or females between 35 and 80 years of age. 2. Symptomatic intracranial arteriosclerosis stenosis with reference diameter 2.25-4.00mm;. 3. Intracranial artery stenosis (≥70%) conformed by DSA. 4. Subjects who voluntarily participate in the study and sign informed consent form.
Exclusion criteria
1. Subjects 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. Disabling stroke with a baseline mRS score ≥3. 4. Lesion artery with severe calcification and close neighbour 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. 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. 7. 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. 8. Accompanied by intracranial tumours or intracranial arteriovenous malformations. 9. The patient who is allergy response to heparin, aspirin, clopidogrel, rapamycin, contrast agents, anaesthetics, or drug eluted stent components. 10. Women who are pregnant or lactating. 11. Due to cognitive or emotional disorders or mental illness, the patient who cannot finish the follow-up. 12. Investigators consider the patient who is not suitable for enrolling in the present trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Any stroke, death and major bleeding | 1 year after operation | Major bleeding was define as intracranial or systemic bleeding requiring hospitalization, blood transfusion or surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| 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 | 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 operation | 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. |
| 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 | 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. |
| 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 | The rate of Hemorrhagic stroke as well as symptomatic ischemic stroke in the target blood supply area. |
| 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 | The rate of Hemorrhagic stroke as well as symptomatic ischemic stroke in the non-target blood supply area. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | Patients with ≥50% stenosis of the vessel. |
| Rate of Device defect | within 5 years of whole trial | 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. |
| Rate of bleeding events at 1 years after operation | 1 year after operation | Bleeding was defined according to Bleeding Academic Research Consortium |
Countries
China
Outcome results
None listed