Balloon angiopLasty for Intracranial Atherosclerotic Minor Stroke/TIA

NCT ID: NCT06014723

Last Updated: 2024-01-03

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 416 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-08-23
• Study Completion Date: 2026-12-01

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.

Conditions

Ischemic Stroke

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Observation group

The observation group received early submaximal balloon angioplasty and medical therapy.

Submaximal balloon angioplasty

Intervention Type: PROCEDURE

The goal of submaximal balloon angioplasty is to use the balloon to improve the stenosis of the criminal artery by more than 20%.

Control group

The control group received only medical therapy.

No interventions assigned to this group

Interventions

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%.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The General Hospital of Northern Theater Command

OTHER

Sponsor Role: collaborator

Shouchun Wang, MD, PhD

OTHER

Sponsor Role: lead

Responsible Party

Shouchun Wang, MD, PhD

Chief physician of the Department of Neurology

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

The First Hospital of Jilin University

Changchun, Jilin, China

Site Status: RECRUITING

Countries

China

Central Contacts

Shouchun Wang, MD, PhD

Role: CONTACT

WSC@jlu.edu.cn

0086-13596060906

Huisheng Chen, MD, PhD

Role: CONTACT

chszh@aliyun.com

0086-13352452086

Facility Contacts

Shouchun MD Wang, MD,PhD

Role: primary

WSC@jlu.edu.cn

13596060906 ext. 0086

References

Qi S, Liu L, Yue FX, Qiu J, Li W, Li C, Nguyen TN, Wei M, Chen HS, Wang SC. Balloon angiopLasty for intracranial Atherosclerotic minor Stroke/TIA (BLAST): study protocol for a multicenter prospective cohort study. Front Neurol. 2024 May 24;15:1385546. doi: 10.3389/fneur.2024.1385546. eCollection 2024.

Reference Type: DERIVED

PMID: 38854963 (View on PubMed)

Other Identifiers

BLAST

Identifier Type: -

Identifier Source: org_study_id