Intracranial Artery Stenosis
Conditions
Brief summary
The primary objective of this trial is to evaluate the safety and efficacy of a new balloon microcatheter in patients with intracranial artery stenosis.
Detailed description
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.
Interventions
DEVICEballoon microcatheter
The balloon microcatheter simultaneously possesses both balloon dilatation and device delivery functions.
Sponsors
Sinomed Neurovita Technology Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. 18 to 80 years of age 2. Patients with intracranial artery stenosis (Degree of stenosis: ≥70%) 3. Target vessel reference diameter must be visually estimated to be 1.25 mm to 4.50 mm 4. Willingness to participate in this clinical trial and signing the consent form for patients or their legally authorised representatives
Exclusion criteria
1. The proximal end of the target vessel is extremely tortuous, severely angulated, or heavily calcified, making it difficult for the device to reach the target vessel 2. Pre-existing severe respiratory, hepatic, or renal diseases (e.g., creatinine ≥ 3.0 mg/dL) or coagulation disorders 3. Disabling stroke with a baseline mRS score ≥ 3 points 4. Non-atherosclerosis diseases 5. Patients with stroke caused by branch occlusion 6. Patients who were participating in other clinical trials who had not yet reached the primary clinical endpoint 7. Known hypersensitivity to aspirin, heparin, anesthetics and contrast agents 8. Investigators consider the patient who is not suitable for enrolling in the present trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of device success | During interventional procedure | 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lesion area, the therapeutic device was successfully delivered via the microcatheter, and the system was successfully withdrawn. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Perioperatively (During interventional procedure) | Number of patients with dissection or occlusion of the target vessel |
| Mortality | Perioperatively (During the in-hospital until discharge) | The proportion of patients who died during the in-hospital until discharge |
| Proportion of adverse events or severe adversary event | Perioperatively (During the in-hospital until discharge) | The proportion of adverse events or severe adverse event |
| Incidence of device defects | Perioperatively (During the in-hospital until discharge) | The proportion of device defects in the process of testing, such as label errors, quality problems, malfunctions, etc. |
Countries
China
Contacts
Primary ContactYong Li Li
Outcome results
None listed