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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGeneral Hospital of Shenyang Military Region

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Submaximal balloon angioplasty

    Procedure/Surgery

    The goal of submaximal balloon angioplasty is to use the balloon to improve the stenosis of the criminal artery by more than 20%.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: SBA groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

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

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

Sponsors and contacts

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