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:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2025-12-24 @ 4:25 PM
NCT ID:
NCT03910166
Eligibility Criteria:
Inclusion Criteria:
* aged between 18 and 80 years old
* symptomatic VAO stenosis refractory to AMM (aggressive medical management)
* etiology of VAOS was atherosclerosis
* the diameter of the normal segment of the artery beyond the stenosis between 3mm and 5mm
* Target lesion has stenosis ≥ 70% evidenced by angiography
* Score on the modified Rankin scale ≤ 3
* NIHSS≤ 6
* Patients have signed informed consent
Exclusion Criteria:
* In-stent restenosis in vertebral artery
* Severe calcified lesion or residual stenosis ≥30% after predilatation or flow-limiting dissection
* Tortuous or variable vessels
* distal serial stenosis or distal vascular dysplasia of the stenosis segment
* Non-atherosclerotic arterial stenosis
* Non-vertebral artery stenosis caused TIA or stroke
* intracranial stent implantation within 12 months
* Intracranial hemorrhage occurred within 3 months
* Obvious thrombosis in brain vessel, or have received thrombolytic therapy 24 hours before procedure
* Active bleeding or coagulation disorders
* Serious liver/kidney damage, not suitable for routine surgical treatment
* Myocardial infarction or extensive cerebral infarction occurred within 2 weeks
* Uncontrolled high blood pressure
* Complicated intracranial tumor, cerebral arteriovenous malformation, or intracranial aneurysm
* Potential sources of cardiogenic thrombosis, such as mitral stenosis, atrial septal defect, aorta or mitral valve replacement, left atrial myxoma, etc
* Life expectancy shorter than 1 years
* Patients whit cognitive impairment or mental disorders
* Known hypersensitivity to aspirin, heparin, clopidogrel,paclitaxel, contrast medium, etc
* Pregnant and lactating women
* Patients who have participated in other clinical trials during the same period that lead to researchers who believe that patients may not be able to follow the trial program
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03910166
Study Brief:
Protocol Section:
NCT03910166