Clinical Trials in China / NCT07170618
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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
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
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lesion area, the therapeutic device was successfully delivered via the microcatheter, and the system was successfully withdrawn.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)
| Facility | City | Region | Status |
|---|---|---|---|
| The Second Affiliated Hospital of Harbin Medical University | Harbin | China |
Other trials for the same condition
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