About this trial
The primary objective of this trial is to evaluate the safety and efficacy of a new balloon microcatheter in patients with intracranial artery stenosis.
Eligibility criteria
Qualifiers
18 to 80 years of age
Patients with intracranial artery stenosis (Degree of stenosis: ≥70%)
Target vessel reference diameter must be visually estimated to be 1.25 mm to 4.50 mm
Willingness to participate in this clinical trial and signing the consent form for patients or their legally authorised representatives
Disqualifiers
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
Pre-existing severe respiratory, hepatic, or renal diseases (e.g., creatinine ≥ 3.0 mg/dL) or coagulation disorders
Disabling stroke with a baseline mRS score ≥ 3 points
Non-atherosclerosis diseases
Trial design
Treatments tested in this trial
- balloon microcatheter