Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate the safety and efficacy of the MedeliverĀ® Intracranial Drug-Coated Balloon Catheter (developed by Beijing Jiu Shi Shen Kang Medical Technology Co., Ltd.) in the endovascular treatment of symptomatic intracranial atherosclerotic stenosis.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test group | Experimental | Intervention: MedeliverĀ® Intracranial Drug-Coated Balloon Catheter Manufacturer: Beijing JSSK Neuro Medical Co., Ltd. |
|
| Control Group | Active Comparator | Intervention: DiveroadĀ® Intracranial Balloon Dilatation Catheter Manufacturer: Beijing JSSK Neuro Medical Co., Ltd. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intracranial Drug-Coated Balloon Catheter (MedeliverĀ®) | Device | The MedeliverĀ® intracranial drug-coated balloon dilatation catheter is indicated for interventional treatment of symptomatic intracranial atherosclerotic stenosis lesions. It restores the original vascular lumen through balloon dilatation of the stenotic segment while simultaneously delivering an anti-proliferative agent (sirolimus/rapamycin) coated on the balloon surface to the lesion site. |
| Measure | Description | Time Frame |
|---|---|---|
| The 12-month post-procedural rates of target lesion restenosis, stroke recurrence or mortality in the territory of the target vessel. | From enrollment to the end of follow-up at 12 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhen Li Beijing Highland Med-Tech Development Co.,Ltd | Contact | 18611537116 | jason.lee@hld-cro.com |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Intracranial Balloon Dilatation Catheter (DiveroadĀ®) | Device | The DiveroadĀ® intracranial balloon dilatation catheter is indicated for interventional treatment of symptomatic intracranial atherosclerotic stenosis lesions. It restores the original vascular lumen through balloon dilatation of the stenotic segment. |
|