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| Name | Class |
|---|---|
| Beijing Tiantan Hospital | OTHER |
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The purpose of the RCT trial is to determine whether DCB is not inferior to stent in treating intracranial stenosis.
This trial is a prospective, multi-center, 1:1 randomized using paclitaxel coated balloon versus stent to treat intracranial stenosis of 70-99% degree. And primary endpoint is angiographic restenosis at 6 months post-procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DCB group | Experimental | use intracranial drug coated balloon catheter made by Acotec Scientific Co.,Ltd. |
|
| Stent group | Active Comparator | use the Intracranial Stent System made by MicroPort. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| drug coated balloon | Device | paclitaxel coated balloon catheter for intracranial PTA treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary efficacy endpoint: Angiographic restenosis of the target lesion | Definition of Restenosis:
| 6 months post-procedure |
| Primary safety endpoint: Target vessel stroke or death event | Stroke (Hemorrhagic stroke and ischemic stroke) or death related to target vessels within 30 days postoperatively. | within 30 days post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Device success rate | DCB: The balloon dilatation catheter was able to reach the treated lesion, successfully dilated without rupture, and successfully retreated. Stent: Successful delivery and deployment of the stent and the delivery system of stent could be retreated successfully. | during procedure |
| Target vessel ischemia stroke event |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhongrong Miao, MD | Beijing Tiantan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital | Beijing | China | ||||
| Nanyang City Central Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40010849 | Derived | Ma G, Sun D, Jia B, Ling L, Nguyen TN, Sun X, Yu B, Wen C, Cheng T, Chen W, Han J, Han H, Guo G, Yu J, Wei L, Huang R, Mao G, Shen Q, Yang X, Wang B, Luo G, Huo X, Gao F, Mo D, Ma N, Miao Z. Comparison of drug-coated balloon with bare-metal stent in patients with symptomatic intracranial atherosclerotic stenosis: the AcoArt sICAS randomized clinical trial. J Neurointerv Surg. 2026 Jan 13;18(2):500-507. doi: 10.1136/jnis-2024-022768. |
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| ID | Term |
|---|---|
| D002537 | Intracranial Arteriosclerosis |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| stent system | Device | The Intracranial Stent System comprises of a balloon expandable stent and a delivery catheter that features a rapid exchange catheter design with a semi-compliant balloon located at its distal end.The product, APOLLO™ stent system, has the indication of endovascular treatment for intracranial stenosis approved by NMPA. |
|
The incidence of recurrent ischemic stroke in the target vessel supply area 31 days to 6 months postoperatively |
| between 31 days and 6 months post-procedure |
| Cerebral parenchyma hemorrhage, subarachnoid hemorrhage or intraventricular hemorrhage events | Any parenchymal hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage 31 days to 6 months postoperatively | between 31 days and 6 months post-procedure |
| Target vessel death event | Target-vessel related death 31 days to 6 months postoperatively | between 31 days and 6 months post-procedure |
| Transient ischemic attack event | transient ischemic attack event transient ischemic attack event | at 6 months post-procedure |
| National Institutes of Health Stroke Scale score | National Institutes of Health Stroke Scale score at 6 months post-procedure(0-42,higher scores mean a worse outcome) | at 6 months post-procedure |
| Modified Rankin Scale score | Modified Rankin Scale score at 6 months post-procedure(0-5,higher scores mean a worse outcome) | at 6 months post-procedure |
| Nanyang |
| China |
| Shanxi Cardiovascular Hospital | Taiyuan | China |
| D009422 | Nervous System Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |