CClinicalTrials.gg
RecruitingNCT06014723Updated Jan 3, 2024

Balloon angiopLasty for Intracranial Atherosclerotic Minor Stroke/TIA

An observational study in Ischemic Stroke, sponsored by Shouchun Wang, MD, PhD. Recruiting at 1 site in China. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-01-03.

Sponsored by Shouchun Wang, MD, PhD · Observational

From the registry’s dates

  • Started Aug 2023; still recruiting 3 years 1 month later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
416
Ages
30 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Ischemic Stroke
03

In context

Stroke

7,283 studies on the registry are indexed under Stroke; 2,013 are open to participants now.

This study's planned enrollment of 416 is above the median of 160 across 1,692 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

This is the only study on the registry with Shouchun Wang, MD, PhD as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 80 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients with minor stroke/transient ischemic attack.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
416 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • ProcedureSubmaximal 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%.

06

What researchers measure

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

    Time frame: 30 days, 1 year

Secondary outcomes

  1. Stroke or death within 30 days after enrollment

    Stroke or death within 30 days after enrollment

    Time frame: 30 days

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

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

    Time frame: 1 year

  3. Restenosis rate of criminal artery within 1 year after enrollment

    Restenosis rate of criminal artery within 1 year after enrollment

    Time frame: 1 year

  4. Evaluation of neurological function improvement within 90 days of enrollment

    Evaluation of neurological function improvement within 90 days of enrollment

    Time frame: 90 days

Other outcomes

  1. Intracranial hemorrhage within 30 days of enrollment

    Intracranial hemorrhage within 30 days of enrollment

    Time frame: 30 days

  2. Complications associated with endovascular therapy

    Complications associated with endovascular therapy

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

07

Study locations

1 of 1 sites recruiting
  • The First Hospital of Jilin University
    Changchun, Jilin 130000, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06014723
Lead sponsor
Shouchun Wang, MD, PhD
Collaborators
The General Hospital of Northern Theater Command
Responsible party
Shouchun Wang, MD, PhD (Chief physician of the Department of Neurology, The First Hospital of Jilin University) — Sponsor-investigator
First posted
Aug 28, 2023
Start date
Aug 23, 2023
Primary completion
Sep 1, 2026 (estimated)
Completion
Dec 1, 2026 (estimated)
Last update
Jan 3, 2024

Study contacts

Shouchun Wang, MD, PhD
Contact
WSC@jlu.edu.cn
0086-13596060906
Huisheng Chen, MD, PhD
Contact
chszh@aliyun.com
0086-13352452086

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion