Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Henan Provincial People's Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
A prospective, multi-center, single-arm study to evaluate the safety and efficacy of drug eluting balloon catheter for the treatment of patients with symptomatic intracranial atherosclerotic stenosis.
This is a prospective, multi-center, single-arm study to evaluate the safety and efficacy of drug eluting balloon catheter (Vmoky) produced by Yinyi (Liaoning) Biotech Co., Ltd. for the treatment of patients with symptomatic intracranial atherosclerotic stenosis.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug eluting balloon (Vmoky) | Experimental | A paclitaxel eluting balloon produced by Yinyi (Liaoning) Biotech Co., Ltd. Balloon length: 8-40 mm, diameter:1.25-5.00 mm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug eluting balloon (Vmoky) | Device | Use Vmoky Drug Eluting Balloon to treat patients with symptomatic intracranial atherosclerosis stenosis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Restenosis | Restenosis was defined as greater than 50% stenosis within or immediately adjacent (within 5 mm) to the implanted balloon(s) or stent(s) and greater than 20% absolute luminal loss. | 6 months (+60 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Angiographic success rate | TICI 3 blood flow, residual stenosis no more than 50% after 5 minutes and no flow-limited dissection | immediately after procedure |
| The success rate of device | device successfully cross the lesion and inflate, post-procedural residual stenosis no more than 50%, no use of bail-out stent |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tianxiao Li | Henan Provincial People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan Provincial People's Hospital | Zhengzhou | Henan | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002545 | Brain Ischemia |
| D002537 | Intracranial Arteriosclerosis |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| immediately after procedure |
| The success rate of procedure | Base on the device success, there is no stroke or death in-hospital | In-hospital (Maximum 7 days after procedure) |
| Target lesion stenosis | Calculate the stenosis degree with Quantitative Coronary Angiography (QCA) method | 6 months (+60 days) and 12 months (±60 days) |
| Restenosis | Restenosis was defined as greater than 50% stenosis within or immediately adjacent (within 5 mm) to the implanted balloon(s) or stent(s) and greater than 20% absolute luminal loss. | 12 months (±60 days) |
| Stroke events | Number of participants that occur these events | 30 days (±7 days), 6 months (±60 days) and 12 months (±60 days) |
| Ischemic stroke and transient ischemic attack (TIA) in the area of the responsible blood vessels | Number of participants that occur these events | 30 days (±7 days), 6 months (±60 days) and 12 months (±60 days) |
| Ischemic stroke and transient ischemic attack (TIA) out of the area of the responsible blood vessels | Number of participants that occur these events | 30 days (±7 days), 6 months (±60 days), 12 months (±60 days) |
| Non-stroke bleeding | Number of participants that occur this event | 12 months (±60 days) |
| Mortality | Number of participants that occur this event | 30 days (±7 days), 6 months (±60 days) and 12 months (±60 days) |
| Serious adverse events and adverse events | Number of participants that occur these events | 12 months (±60 days) |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020765 | Intracranial Arterial Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |