NCT06014723 Balloon angiopLasty for Intracranial Atherosclerotic Minor Stroke/TIA
| NCT ID | NCT06014723 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shouchun Wang, MD, PhD |
| Condition | Ischemic Stroke |
| Study Type | OBSERVATIONAL |
| Enrollment | 416 participants |
| Start Date | 2023-08-23 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 416 participants in total. It began in 2023-08-23 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The objective of this study was to evaluate the safety and efficacy of early submaximal balloon angioplasty combined with medical therapy vs medical therapy alone for minor stroke/transient ischemic attack with intracranial atherosclerosis etiology.
Eligibility Criteria
Inclusion Criteria: 1. age range of 30-80 years; 2. symptomatic ICAS (C4-C7 segments of ICA, M1 segment of the MCA, V4 segment of the VA, and BA) with 70%-99% stenosis confirmed by DSA; 3. minor stroke (NIHSS score ≤5) within 1 week of onset or from symptom exacerbation (NIHSS score increased by ≥2 points) or intermediate- to high-risk TIA, defined as ABCD2 score ≥4 within 1 week of the last symptom episode; 4. diameter of the culprit artery ranging from 2.0 to 4.5mm, and the length of the stenosis≤14mm; 5. mRS ≤ 2 before endovascular treatment； 6. no large ischemic region found on CT or MRI (ASPECTS≥ 6 or pc-ASPECTS ≥8)； 7. written informed consent obtained from the patient or legally responsible person. Exclusion Criteria: 1. allergy to contrast media; 2. non-atherosclerotic disease-related stenosis, such as arterial dissection, Moya-Moya disease, and arteritis; 3. penetrating branch lesion ipsilateral to the target lesion (infarction caused by penetrating branch occlusion is defined as stenosis of the MCA or BA, but only with simple basal ganglia or brainstem/thalamic infarction); 4. presence of severe stenosis of the extracranial segment on the side of the target lesion; 5. previous endovascular treatment of the ipsilateral vessel; 6. presence of intracranial aneurysms, tumors, and vascular malformations; 7. any form of ipsilateral intracranial hemorrhage within 3 months and contralateral intracranial hemorrhage within 2 weeks; 8. presence of atrial fibrillation, severe heart dysfunction, liver or kidney dysfunction; patients with tumors and serious diseases whose expected survival time is ≤ 1 year; 9. hemoglobin ≤ 100g/L, platelet count ≤ 100×10\^9/L, INR\> 1.5 (irreversible), coagulopathy or irremediable bleeding factors; 10. uncontrollable hypertension: systolic blood pressure \>185 mmHg and/or diastolic blood pressure \>110 mmHg; 11. poor glycemic control (random blood glucose \> 22.2 mmol/L); 12. history of major surgery within 30 days prior to enrollment or surgery plan within 90 days after enrollment; 13. pregnancy or lactation; 14. other conditions that the researchers think make the patient unsuitable for the study.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06014723 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 80 Years, studying Ischemic Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06014723 currently recruiting?
Yes, NCT06014723 is actively recruiting participants. Contact the research team at WSC@jlu.edu.cn for enrollment information.
Where is the NCT06014723 trial being conducted?
This trial is being conducted at Changchun, China.
Who is sponsoring the NCT06014723 clinical trial?
NCT06014723 is sponsored by Shouchun Wang, MD, PhD. The trial plans to enroll 416 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.