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Balloon angiopLasty for Intracranial Atherosclerotic Minor Stroke/TIA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06014723
Recruitment Status : Recruiting
First Posted : August 28, 2023
Last Update Posted : January 3, 2024
Sponsor:
Collaborator:
The General Hospital of Northern Theater Command
Information provided by (Responsible Party):
Shouchun Wang, MD, PhD, The First Hospital of Jilin University

Study Description
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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.

Condition or disease Intervention/treatment
Ischemic Stroke Procedure: Submaximal balloon angioplasty

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.
Study Design
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Study Type : Observational
Estimated Enrollment : 416 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Balloon angiopLasty for Intracranial Atherosclerotic Minor Stroke/TIA: a Prospective, Multi-center, Register Study
Actual Study Start Date : August 23, 2023
Estimated Primary Completion Date : September 1, 2026
Estimated Study Completion Date : December 1, 2026

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Observation group
The observation group received early submaximal balloon angioplasty and medical therapy.
 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%.
Control group
The control group received only medical therapy.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    Stroke or death within 30 days or ischemic stroke in the culprit artery territory from 30 days to 1 year


Secondary Outcome Measures :
  1. Stroke or death within 30 days after enrollment [ Time Frame: 30 days ]
    Stroke or death within 30 days after enrollment

  2. Ischemic stroke in the territory of criminal artery from 30 days to 1 year after enrollment [ Time Frame: 1 year ]
    Ischemic stroke in the territory of criminal artery from 30 days to 1 year after enrollment

  3. Restenosis rate of criminal artery within 1 year after enrollment [ Time Frame: 1 year ]
    Restenosis rate of criminal artery within 1 year after enrollment

  4. Evaluation of neurological function improvement within 90 days of enrollment [ Time Frame: 90 days ]
    Evaluation of neurological function improvement within 90 days of enrollment


Other Outcome Measures:
  1. Intracranial hemorrhage within 30 days of enrollment [ Time Frame: 30 days ]
    Intracranial hemorrhage within 30 days of enrollment

  2. Complications associated with endovascular therapy [ Time Frame: 24 hours, discharge, 30 days, 90 days, and 1 year after enrollment ]
    Complications associated with endovascular therapy


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients with minor stroke/transient ischemic attack.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06014723


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

Locations
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China, Jilin
The First Hospital of Jilin University Recruiting
Changchun, Jilin, China, 130000
Contact: Shouchun MD Wang, MD,PhD    13596060906 ext 0086    WSC@jlu.edu.cn   
Sponsors and Collaborators
Shouchun Wang, MD, PhD
The General Hospital of Northern Theater Command
More Information
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Responsible Party: Shouchun Wang, MD, PhD, Chief physician of the Department of Neurology, The First Hospital of Jilin University
ClinicalTrials.gov Identifier: NCT06014723    
Other Study ID Numbers: BLAST
First Posted: August 28, 2023    Key Record Dates
Last Update Posted: January 3, 2024
Last Verified: January 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Cerebrovascular Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases