Not provided
Not provided
Not provided
Not provided
Not provided
Subgroup analysis based on the main study (NCT05692882), not registered separately.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3 months DAPT Intervention | Experimental | 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. |
|
| 6 months DAPT Intervention | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NOVA intracranial sirolimus-eluting stent system | Device | The NOVA stent is a sirolimus-eluting stent system designed for intracranial artery stenosis with a rapid exchangeable balloon. |
| Measure | Description | Time Frame |
|---|---|---|
| Any stroke, death and major bleeding | Major bleeding was define as intracranial or systemic bleeding requiring hospitalization, blood transfusion or surgery. | 1 year after operation |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year after operation |
Not provided
Inclusion criteria
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lianbo Gao | The Fourth Affiliated Hospital of China Medical University | Principal Investigator |
| Jianfeng Han | First Affiliated Hospital Xi'an Jiaotong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Fourth Affiliated Hospital of China Medical University | Ha’erbin | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | within 5 years of whole trial |
| Rate of bleeding events at 1 years after operation | Bleeding was defined according to Bleeding Academic Research Consortium | 1 year after operation |
| ID | Term |
|---|---|
| D002537 | Intracranial Arteriosclerosis |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided