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| Name | Class |
|---|---|
| Beijing Tiantan Hospital | OTHER |
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The purpose of the study is to evaluate the safety and feasibility of drug coated balloon in treatment of intracranial in-stent restenosis.
This study is a prospective, multi-center, randomized controlled trial using drug coated balloon versus uncoated PTA balloon in treatment of intracranial in-stent restenosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DCB group | Experimental | use drug (paclitaxel) coated balloon to treat intracranial in-stent restenosis |
|
| PTA group | Active Comparator | use PTA balloon to treat intracranial in-stent restenosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| drug (paclitaxel) coated balloon | Device | use drug (paclitaxel) coated balloon catheter to treat intracranial in-stent restenosis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Target vessel stroke or death event | Target-vessel related stroke (bleeding and ischemia) or death within 30 days postoperatively. | within 30 days post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| device success rate | The balloon dilatation catheter was able to reach the treated lesion, successfully dilated without rupture, and successfully retreated. | assessed during procedure |
| target vessel ischemia stroke event |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ning Ma, MD | Contact | 010-59978585 | maning_03@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ning Ma, MD | Beijing Tiantan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital | Recruiting | Beijing | China |
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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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| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |
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| PTA balloon | Device | use traditional PTA balloon with NMPA approval of indication for treating intracranial stenosis |
|
The incidence of recurrent ischemic stroke in the target vessel supply area 31 days to 12 months after surgery
| between 31days and 12months post-procedure |
| Cerebral parenchyma hemorrhage, subarachnoid hemorrhage or intraventricular hemorrhage events | Any cerebral parenchyma hemorrhage, subarachnoid hemorrhage, or intraventricular hemorrhage confirmed by MRI or CT from 31 days to 12 months post procedure | between 31 days and 12 months post-procedure |
| target vessel death event | Target-vessel related death 31 days to 12 months postoperatively | between 31 days and 12 months post-procedure |
| National Institutes of Health Stroke Scale score | National Institutes of Health Stroke Scale score at 12 months postoperatively(0-42, higher scores mean a worse outcome) | at 12 months post-procedure |
| Modified Rankin Score score | Modified Rankin Score at 12 months postoperatively(0-5, higher scores mean a worse outcome) | at 12 months post-procedure |
| D009422 | Nervous System Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |