Not Yet RecruitingNot Applicable

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

China56 participantsStarted 2025-09-01

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

Rate of device success

Timeframe: During interventional procedure

Trial details

NCT IDNCT07170618

SponsorSinomed Neurovita Technology Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-30

Contact for this trial

Yong Li Li

13904611005 liyongli9999@163.com

View on ClinicalTrials.gov More Intracranial Artery Stenosis trials