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Efficacy and Safety of a New Balloon Microcatheter in the Treatment of Intracranial Artery Stenosis

NCT07170618 · tracked via the Priya Life Science China tracker
Sponsor
Sinomed Neurovita Technology Inc
Phase
Not applicable
Started
2025-09-01
Last updated
2025-09-12

Condition(s) studied

Intracranial Artery Stenosis

Investigational drug(s) / intervention(s)

balloon microcatheter

balloon microcatheter: The balloon microcatheter simultaneously possesses both balloon dilatation and device delivery functions.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
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

Primary outcome measure(s)

  • 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lesion area, the therapeutic device was successfully delivered via the microcatheter, and the system was successfully withdrawn.

Trial sites (1)

FacilityCityRegionStatus
The Second Affiliated Hospital of Harbin Medical University Harbin China
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07170618 on ClinicalTrials.gov ↗ ← All trials in China