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Recruiting NCT06014723

Balloon angiopLasty for Intracranial Atherosclerotic Minor Stroke/TIA

— Observational Ischemic Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Submaximal balloon angioplasty.
Who it may be relevant to
Registry conditions: Ischemic Stroke. Basic parameters: 30 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Balloon angiopLasty for Intracranial Atherosclerotic Minor Stroke/TIA: a Prospective, Multi-center, Register Study

Overview

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.

Interventions

  • 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%.

Primary outcome measures

  • Stroke or death within 30 days or ischemic stroke in the culprit artery territory from 30 days to 1 year [Time frame: 30 days, 1 year]
Secondary outcome measures (4)
  • Stroke or death within 30 days after enrollment [Time frame: 30 days]
  • Ischemic stroke in the territory of criminal artery from 30 days to 1 year after enrollment [Time frame: 1 year]
  • Restenosis rate of criminal artery within 1 year after enrollment [Time frame: 1 year]
  • Evaluation of neurological function improvement within 90 days of enrollment [Time frame: 90 days]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

China · 1 center
  • The First Hospital of Jilin University — Changchun

Publications

  • 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

Identifiers

NCT: NCT06014723 · BLAST

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗