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A multicenter, open-label, blinded-endpoint, prospective, randomized controlled clinical trial with an "all comers" design.
The main objective of this study is to investigate the impact of angiography-derived fractional flow (Angio-FF) on diagnostic and therapeutic decision-making in patients with symptomatic intracranial atherosclerotic stenosis (sICAS). The study aims to evaluate whether stenting plus medical therapy, compared to medical therapy alone, can benefit patients selected through Angio-FF screening.
For Group A, patients with significant stenosis and hemodynamic impairment identified through Angio-FF (≤0.7) screening are expected to have a higher risk. The patients will be enrolled in RCT trial, with a planned enrollment of 336 subjects.
For Group B, patients with significant stenosis but without hemodynamic impairment identified through Angio-FF (>0.7) screening will be included in the registry cohort, with a planned enrollment of 200 subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Stenting plus medical therapy |
|
| Control group | Active Comparator | Medical therapy alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stenting plus medical therapy | Combination Product | Patients randomized to intervention group received the percutaneous transluminal balloon angioplasty with stenting within 5 days after randomization, and loading dose of aspirin and clopidogrel was allowed. Received aspirin, 100mg, plus clopidogrel, 75 mg, daily for 90 days after procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Stroke or death | Stroke or death within 30 days after enrollment; Or stroke in the territory of the symptomatic intracranial artery (SIT) between 30 days and 1 year. | Stroke or death within 30 days after enrollment; Or stroke in the territory of the symptomatic intracranial artery (SIT) between 30 days and 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| Ischemic stroke in the target vessel territory | Ischemic stroke in the target vessel territory | Within 1-3 years after enrollment |
| Ischemic stroke in non-target vessel territory | Ischemic stroke in non-target vessel territory |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pengfei Yang, M.D. | Contact | 86-21-31161784 | 15921196312@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jianimin Liu, M.D. | Changhai Hospital | Principal Investigator |
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Data can be shared with bona fide researchers after the publication of the main results, based on a submitted protocol to Oriental Collaboration group on Emerging Advanced therapy for Neurovascular diseases Consortium.
Data sharing will be available from 12 months after the publication of the main results.
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|
| Medical therapy alone | Drug | Medical therapy alone: received aspirin, 100mg, plus clopidogrel, 75 mg, daily for 90 days after randomisation. |
|
| Within 30 days to 1 year, and within 1-3 years after enrollment |
| Any occurrence of cerebral hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage | Any occurrence of cerebral hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage | Within 30 days to 3 years after enrollment |
| Any cause of death | Any cause of death | Within 30 days to 3 years after enrollment |
| mRS score | Modified Rankin scale (mRS) score. The value range 0-6: higher scores mean a worse outcome. | At 1 year, 2 years, and 3 years after enrollment |
| National Institutes of Health Stroke Scale (NIHSS) score | Stroke severity (NIHSS score). The value range 0-42: higher scores mean a worse outcome. | At 1 year, 2 years, and 3 years after enrollment |
| Barthel Index | An ordinal scale which measures a person's ability to complete activities of daily living. The value range 0-100: higher scores mean a better outcome. | At 1 year, 2 years, and 3 years after enrollment |
| 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 |
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| ID | Term |
|---|---|
| D015607 | Stents |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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