Balloon angiopLasty for Intracranial Atherosclerotic Minor Stroke/TIA
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
In this study, 416 patients with minor strokes or transient ischemic attacks due to symptomatic intracranial atherosclerotic stenosis within one week of the onset of last ischemic symptoms from 20 centers in China were enrolled. The observation group received early submaximal balloon angioplasty, while the control group received only medical therapy. Two groups will be followed up for 1 year 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Observation group The observation group received early submaximal balloon angioplasty and medical therapy. |
Procedure: Submaximal balloon angioplasty
The goal of submaximal balloon angioplasty is to use the balloon to improve the stenosis of the criminal artery by more than 20%.
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| Control group The control group received only medical therapy. |
Outcome Measures
Primary Outcome Measures
- Stroke or death within 30 days after enrollment, or ischemic stroke in the territory of criminal artery from 30 days to 1 year after enrollment. [30 days, 1 year]
Stroke or death within 30 days after enrollment, or ischemic stroke in the territory of criminal artery from 30 days to 1 year after enrollment.
Secondary Outcome Measures
- Stroke or death within 30 days after enrollment [30 days]
Stroke or death within 30 days after enrollment
- Ischemic stroke in the territory of criminal artery from 30 days to 1 year after enrollment [1 year]
Ischemic stroke in the territory of criminal artery from 30 days to 1 year after enrollment
- Restenosis rate of criminal artery within 1 year after enrollment [1 year]
Restenosis rate of criminal artery within 1 year after enrollment
- Evaluation of neurological function improvement within 90 days of enrollment [90 days]
Evaluation of neurological function improvement within 90 days of enrollment
Other Outcome Measures
- Intracranial hemorrhage within 30 days of enrollment [30 days]
Intracranial hemorrhage within 30 days of enrollment
- Complications associated with endovascular therapy [24 hours, discharge, 30 days, 90 days, and 1 year after enrollment]
Complications associated with endovascular therapy
Eligibility Criteria
Criteria
Inclusion Criteria:
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The age range is 30-80 years old;
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Symptomatic atherosclerotic large artery stenosis in intracranial segments and 70-99% stenosis confirmed by DSA;
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Minor stroke (NIHSS score ≤5) or intermediate- to high-risk TIA within 1 week of onset, with intermediate- to high-risk TIA defined as ABCD2 score ≥4;
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The diameter of the criminal artery ranged from 2.0 to 4.5mm, and the length of the stenosis of the criminal artery ranged from less than 14mm;
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mRS ≤ 2 before endovascular treatment；
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No large ischemic region was found on CT or MRI；
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Written informed consent obtained from the patient or legally responsible person.
Exclusion Criteria:
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Allergy to contrast media;
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Non-atherosclerotic disease-related stenosis: arterial dissection, Moya-Moya disease, arteritis, etc;
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Penetrating branch lesion;
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Presence of severe stenosis of the extracranial segment on the side of the target lesion;
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Previous endovascular treatment of the ipsilateral vessel was performed;
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Presence of intracranial aneurysms, tumors, and vascular malformations;
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Any form of ipsilateral intracranial hemorrhage within 3 months and contralateral intracranial hemorrhage within 2 weeks;
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Combined with atrial fibrillation, severe heart function, liver or kidney dysfunction; patients with tumors and serious diseases whose expected survival time is less than 1 year;
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Hemoglobin less than 100g/L, platelet count less than 100×10^9/L, international standardized ratio (INR) > 1.5 (irreversible), coagulopathy or irremediable bleeding factors;
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Uncontrollable hypertension: systolic blood pressure >185 mmHg and or diastolic blood pressure >110 mmHg;
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Poor glycaemic control (random blood glucose > 22.2 mmol/L);
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History of major surgery within 30 days prior to enrollment or surgery plan within 90 days after enrollment;
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Pregnancy or lactation;
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Other conditions that the researchers think the patient unsuitable for the study.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Shouchun Wang, MD, PhD
- The General Hospital of Northern Theater Command
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BLAST