Tests balloon angioplasty for minor stroke caused by brain artery narrowing
Tests a balloon procedure to open narrowed brain arteries in adults with minor stroke.
Plain-language title generated from the registry record
Registry title: Balloon angiopLasty for Intracranial Atherosclerotic Minor Stroke/TIA
Key facts
- Where
- Changchun, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 30 and 80 years old?
Source: NCT06014723, who can take part
Where in China
- The First Hospital of Jilin UniversityChangchun, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shouchun Wang, MD, PhD
- Trial code
- NCT06014723
- Record updated
- 3 January 2024
- Original description
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.Read full original descriptionShow less
Balloon angiopLasty for Intracranial Atherosclerotic Minor Stroke/TIA: a Prospective, Multi-center, Register Study
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.
Inclusion: age range of 30-80 years; 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; 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; diameter of the culprit artery ranging from 2.0 to 4.5mm, and the length of the stenosis≤14mm; mRS ≤ 2 before endovascular treatment；; no large ischemic region found on CT or MRI (ASPECTS≥ 6 or pc-ASPECTS ≥8)；; written informed consent obtained from the patient or legally responsible person.
Exclusion: previous endovascular treatment of the ipsilateral vessel; history of major surgery within 30 days prior to enrollment or surgery plan within 90 days after enrollment; allergy to contrast media; non-atherosclerotic disease-related stenosis, such as arterial dissection, Moya-Moya disease, and arteritis; any form of ipsilateral intracranial hemorrhage within 3 months and contralateral intracranial hemorrhage within 2 weeks; presence of atrial fibrillation, severe heart dysfunction, liver or kidney dysfunction; patients with tumors and serious diseases whose expected survival time is ≤ 1 year; uncontrollable hypertension: systolic blood pressure >185 mmHg and/or diastolic blood pressure >110 mmHg; other conditions that the researchers think make the patient unsuitable for the study; hemoglobin ≤ 100g/L, platelet count ≤ 100×10\^9/L, INR> 1.5 (irreversible), coagulopathy or irremediable bleeding factors; poor glycemic control (random blood glucose > 22.2 mmol/L); 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); presence of severe stenosis of the extracranial segment on the side of the target lesion; presence of intracranial aneurysms, tumors, and vascular malformations; pregnancy or lactation.