Balloon angiopLasty for Intracranial Atherosclerotic Minor Stroke/TIA

NCT06014723 | Recruiting DMC

• 1 other identifier: BLAST
• Study Type: observational
• Target: 416
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• Stroke or death within 30 days or ischemic stroke in the culprit artery territory from 30 days to 1 year

  Stroke or death within 30 days or ischemic stroke in the culprit artery territory from 30 days to 1 year

  30 days, 1 year

Secondary Outcomes (4)

• Stroke or death within 30 days after enrollment

  30 days

• Ischemic stroke in the territory of criminal artery from 30 days to 1 year after enrollment

  1 year

• Restenosis rate of criminal artery within 1 year after enrollment

  1 year

• Evaluation of neurological function improvement within 90 days of enrollment

  90 days

Other Outcomes (2)

• Intracranial hemorrhage within 30 days of enrollment

  30 days

• Complications associated with endovascular therapy

  24 hours, discharge, 30 days, 90 days, and 1 year after enrollment

Study Arms (2)

Observation group

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

Procedure: Submaximal balloon angioplasty

Control group

The control group received only medical therapy.

Interventions

Submaximal balloon angioplasty PROCEDURE

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

Observation group

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with minor stroke/transient ischemic attack.

You may qualify if:

• 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.

You may not qualify if:

• allergy to contrast media;
• non-atherosclerotic disease-related stenosis, such as arterial dissection, Moya-Moya disease, and arteritis;
• 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;
• previous endovascular treatment of the ipsilateral vessel;
• presence of intracranial aneurysms, tumors, and vascular malformations;
• 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;
• hemoglobin ≤ 100g/L, platelet count ≤ 100×10\^9/L, INR\> 1.5 (irreversible), coagulopathy or irremediable bleeding factors;
• uncontrollable hypertension: systolic blood pressure \>185 mmHg and/or diastolic blood pressure \>110 mmHg;
• poor glycemic control (random blood glucose \> 22.2 mmol/L);
• history of major surgery within 30 days prior to enrollment or surgery plan within 90 days after enrollment;
• pregnancy or lactation;
• other conditions that the researchers think make the patient unsuitable for the study.

Sponsors & Collaborators

• Shouchun Wang, MD, PhD: lead
• The General Hospital of Northern Theater Command: collaborator

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, 130000, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 38854963 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Shouchun Wang, MD, PhD

CONTACT

0086-13596060906; WSC@jlu.edu.cn

Huisheng Chen, MD, PhD

CONTACT

0086-13352452086; chszh@aliyun.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief physician of the Department of Neurology

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: August 28, 2023
• Study Start: August 23, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 3, 2024

Record last verified: 2024-01

Locations

CN (1)