Actively Recruiting

Age: 30Years - 80Years
All Genders
NCT06014723

Balloon angiopLasty for Intracranial Atherosclerotic Minor Stroke/TIA

Led by Shouchun Wang, MD, PhD · Updated on 2024-01-03

416

Participants Needed

1

Research Sites

170 weeks

Total Duration

On this page

Sponsors

S

Shouchun Wang, MD, PhD

Lead Sponsor

T

The General Hospital of Northern Theater Command

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Balloon angiopLasty for Intracranial Atherosclerotic Minor Stroke/TIA

Who Can Participate

Age: 30Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 30 and 80 years
  • Symptomatic intracranial atherosclerotic stenosis with 70%-99% narrowing confirmed by imaging
  • Minor stroke (NIHSS score 5 or less) within 1 week of onset or worsening symptoms, or intermediate to high-risk transient ischemic attack with ABCD2 score of 4 or higher within 1 week
  • Diameter of affected artery between 2.0 and 4.5 mm and stenosis length 14 mm or less
  • Modified Rankin Scale score 2 or less before treatment
  • No large ischemic area on CT or MRI scans (ASPECTS 6 or higher, pc-ASPECTS 8 or higher)
  • Written informed consent given by the patient or legal representative
Not Eligible

You will not qualify if you...

  • Allergy to contrast media
  • Non-atherosclerotic artery diseases like arterial dissection, Moya-Moya disease, or arteritis
  • Lesion caused by penetrating branch occlusion on the same side as the target artery
  • Severe narrowing of the extracranial artery on the side of the affected artery
  • Previous endovascular treatment of the same vessel
  • Presence of intracranial aneurysms, tumors, or vascular malformations
  • Intracranial hemorrhage on the same side within 3 months or opposite side within 2 weeks
  • Atrial fibrillation, severe heart, liver, or kidney dysfunction; serious diseases with expected survival of 1 year or less
  • Low hemoglobin or platelet counts, clotting disorders, or bleeding risks
  • Uncontrolled high blood pressure (systolic >185 mmHg or diastolic >110 mmHg)
  • Poor blood sugar control (random glucose over 22.2 mmol/L)
  • Major surgery within 30 days before enrollment or planned surgery within 90 days after
  • Pregnancy or breastfeeding
  • Other conditions making the patient unsuitable according to the researchers

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The First Hospital of Jilin University

Changchun, Jilin, China, 130000

Actively Recruiting

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Research Team

S

Shouchun Wang, MD, PhD

CONTACT

H

Huisheng Chen, MD, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Balloon angiopLasty for Intracranial Atherosclerotic Minor Stroke/TIA | DecenTrialz