Efficacy and Safety of a New Balloon Microcatheter in the Treatment of Intracranial Artery Stenosis
NCT ID: NCT07170618
Last Updated: 2025-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
56 participants
INTERVENTIONAL
2025-09-01
2025-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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balloon microcatheter
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.
balloon microcatheter
The balloon microcatheter simultaneously possesses both balloon dilatation and device delivery functions.
Interventions
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balloon microcatheter
The balloon microcatheter simultaneously possesses both balloon dilatation and device delivery functions.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
80 Years
ALL
No
Sponsors
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Sinomed Neurovita Technology Inc.
INDUSTRY
Responsible Party
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Locations
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The Second Affiliated Hospital of Harbin Medical University
Harbin, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SINOMED-BMC-2025
Identifier Type: -
Identifier Source: org_study_id
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