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NCT Number: NCT06763458

Balloon Angioplasty for Minor Unstable Stroke With IntraCranial Atherosclerosis Stenosis (BAMUS-ICAS)

Intracranial atherosclerotic stenosis (ICAS) is a common cause of stroke, especially in East and South Asia, and is significantly associated with stroke recurrence and early neurological deterioration (END) despite aggressive medical management. Minor stroke (National Institutes of Health Stroke, NIHSS score ≤ 5) patients with ICAS often has higher risk of END. The early realization of blood flow patency is closely related to the improvement of patient outcomes. Submaximal balloon angioplasty (SBA) as a safer and simpler intervention which can improve cerebral blood flow. Thus, SBA may be an effective strategy for preventing END in acute ischemic stroke patients with ICAS.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

General Hospital of Northern Theater Command

Shenyang, 110840, China

Location status: Recruiting

Location contact

Zi-Ai Zhao

CONTACT

[email protected]

+862428897491

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Over 18 years of age;
  • Minor ischemic stroke within 1 week of onset (NIHSS≤5);
  • Have received the best drug treatment (dual antibody, anti-plate combined with anticoagulation), but symptoms still have measurable fluctuations or progression (NIHSS increased by at least 1 point);
  • Symptoms fluctuate to the time of receiving balloon dilation within 24 hours;
  • The etiology was considered to be severe stenosis of the responsible vessels due to intracranial arteriosclerosis (70-99% stenosis), or perforator artery disease with severe stenosis of the carrier artery (confirmed by MRA, CTA or DSA);
  • Patients with first onset or past onset without sequelae such as limb paralysis should not affect the score of this NIHSS, and mRS Score of patients with past onset should be less than 2 points;
  • Patients or family members sign informed consent.

Exclusion criteria

  • Patients who have developed large intracranial vessel occlusion;
  • Intracranial hemorrhagic diseases in the past 3 months: cerebral hemorrhage, subarachnoid hemorrhage, etc.;
  • Non-atherosclerotic disease-related stenosis: arterial dissection, moya-moya disease, arterioinflammatory disease, etc.
  • Clotting disorders or systemic bleeding tendency or platelets less than 100,000;
  • Complicated with serious infection or liver, kidney and other serious diseases;
  • Patients with severe inability to control hypertension (systolic blood pressure >200mmHg or diastolic blood pressure >110mmHg);
  • Women who are pregnant, have a pregnancy plan or are breastfeeding;
  • Complicated with other serious diseases, life expectancy < 6 months; Other conditions deemed inappropriate for participation in this study.

Treatment and study plan

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%.

Primary outcomes

  1. Proportion of early neurological deterioration (NIHSS score increase of 4 points or more)

    Time frame: at 24±8 hours

Secondary outcomes

  1. The decrease of NIHSS score

    Time frame: at 24±8 hours

  2. The decrease of NIHSS score

    Time frame: at 10±2 days

  3. Proportion of early neurological improvement (NIHSS score decline of 4 points or 0)

    Time frame: at 24±8 hours

  4. Proportion of patients with modified Rankin Score 0 to 1

    Time frame: at 90±7 days

  5. Proportion of patients with modified Rankin Score 0 to 2

    Time frame: at 90±7 days

  6. Distribution of patients with modified Rankin Score

    Time frame: at 90±7 days

  7. the occurence of stroke or other cardiovascular events

    Time frame: at 90±7 days

  8. ischemic stroke in the culprit artery territory

    Time frame: at 90±7 days

  9. Incidence of symptomatic intracranial hemorrhage (ECASS-III criteria)

    Time frame: at 24±8 hours

  10. Proportion of occurrence of cerebral parenchymal hemorrhage types (PH1) and (PH2)

    Time frame: at 24±8 hours

  11. Proportion of serious adverse events

    Time frame: at 24±8 hours

  12. Proportion of all-cause deaths

    Time frame: at 10±2 days

  13. Complications associated with endovascular therapy

    Time frame: at 24±8 hours, at 10±2 days, at 90±7 days

Other outcomes

  1. Changes in cortical oxygen saturation

    Time frame: at 24±8 hours

  2. Changes of cerebral blood flow autoregulation function

    Time frame: at 24±8 hours

Study contacts

Contact information is provided by the study sponsor or research team.

Hui-Sheng Chen

CONTACT

[email protected]

+86-024-28897511

Sponsors and collaborators

Lead sponsor

General Hospital of Shenyang Military Region

Other

Registry information

Official study title

Balloon Angioplasty for Minor Unstable Stroke With IntraCranial Atherosclerosis Stenosis (BAMUS-ICAS): a Prospective, Randomized, Multi-center Study

Acronym: BAMUS-ICAS

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 8, 2025
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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