Clinical trial NCT06014723: Balloon angiopLasty for Intracranial Atherosclerotic Minor Stroke/TIA
Official title: Balloon angiopLasty for Intracranial Atherosclerotic Minor Stroke/TIA: a Prospective, Multi-center, Register Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ischemic Stroke
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
Collaborators: name: The General Hospital of Northern Theater Command
First posted: 2023-08-28
Enrollment: 416
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with minor stroke/transient ischemic attack.

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.

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.

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.

Primary outcomes:
measure: Stroke or death within 30 days or ischemic stroke in the culprit artery territory from 30 days to 1 year
timeFrame: 30 days, 1 year
Secondary outcomes:
measure: Stroke or death within 30 days after enrollment
timeFrame: 30 days
measure: Ischemic stroke in the territory of criminal artery from 30 days to 1 year after enrollment
timeFrame: 1 year
measure: Restenosis rate of criminal artery within 1 year after enrollment
timeFrame: 1 year
measure: Evaluation of neurological function improvement within 90 days of enrollment
timeFrame: 90 days
Other outcomes:
measure: Intracranial hemorrhage within 30 days of enrollment
timeFrame: 30 days
measure: Complications associated with endovascular therapy
timeFrame: 24 hours, discharge, 30 days, 90 days, and 1 year after enrollment
Locations:
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
Study officials:
References: