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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
56
The balloon microcatheter simultaneously possesses both balloon dilatation and device delivery functions.
The Second Affiliated Hospital of Harbin Medical University
Harbin, China
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lesion area, the therapeutic device was successfully delivered via the microcatheter, and the system was successfully withdrawn.
Time frame: During interventional procedure
Incidence of cerebrovascular events, including transient ischemic attack (TIA), ischemic stroke, and hemorrhagic stroke.
Time frame: 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
Time frame: Perioperatively (During interventional procedure)
Mortality
The proportion of patients who died during the in-hospital until discharge
Time frame: Perioperatively (During the in-hospital until discharge)
Proportion of adverse events or severe adversary event
The proportion of adverse events or severe adverse event
Time frame: 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.
Time frame: Perioperatively (During the in-hospital until discharge)
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