Status:
NOT_YET_RECRUITING
Efficacy and Safety of a New Balloon Microcatheter in the Treatment of Intracranial Artery Stenosis
Lead Sponsor:
Sinomed Neurovita Technology Inc.
Conditions:
Intracranial Artery Stenosis
Eligibility:
All Genders
18-80 years
Phase:
NA
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....
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Patients with stroke caused by branch occlusion
- Patients who were participating in other clinical trials who had not yet reached the primary clinical endpoint
- Known hypersensitivity to aspirin, heparin, anesthetics and contrast agents
- Investigators consider the patient who is not suitable for enrolling in the present trial
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT07170618
Start Date
September 1 2025
End Date
December 30 2025
Last Update
September 12 2025
Active Locations (1)
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1
The Second Affiliated Hospital of Harbin Medical University
Harbin, China