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
The primary objective of this trial is to evaluate the safety and efficacy of a new balloon microcatheter in patients with intracranial artery stenosis.
This study is a prospective, multicenter, objective performance criteria clinical trial to evaluate the safety and efficacy of a balloon microcatheter in the treatment of intracranial artery stenosis. A total of 56 patients are planned to be included. The endpoints include device success, target vessel dissection, target vessel occlusion, mortality and cerebrovascular events, assessed during the in-hospital until discharge.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| balloon microcatheter | Experimental | For the treatment of intracranial artery stenosis, balloon microcatheter would combine the advantages of balloon dilatation first and then, if necessary, the additional deployment of a self-expandable stent via the same balloon microcatheter lumen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| balloon microcatheter | Device | The balloon microcatheter simultaneously possesses both balloon dilatation and device delivery functions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of device success | The system was successfully delivered to the target site, the balloon was successfully inflated at the lesion area, the therapeutic device was successfully delivered via the microcatheter, and the system was successfully withdrawn. | During interventional procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of cerebrovascular events, including transient ischemic attack (TIA), ischemic stroke, and hemorrhagic stroke. | Perioperatively (During the in-hospital until discharge) | |
| Rate of target vessel dissection, target vessel occlusion | Number of patients with dissection or occlusion of the target vessel |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yong Li Li | Contact | 13904611005 | liyongli9999@163.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Harbin Medical University | Harbin | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Perioperatively (During interventional procedure) |
| Mortality | The proportion of patients who died during the in-hospital until discharge | Perioperatively (During the in-hospital until discharge) |
| Proportion of adverse events or severe adversary event | The proportion of adverse events or severe adverse event | Perioperatively (During the in-hospital until discharge) |
| Incidence of device defects | The proportion of device defects in the process of testing, such as label errors, quality problems, malfunctions, etc. | Perioperatively (During the in-hospital until discharge) |