Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT07170618
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07170618
Study Brief:
Protocol Section:
NCT07170618