Ischemic StrokeBAMUS-ICASNCT06763458
Balloon Angioplasty for Minor Unstable Stroke With IntraCranial Atherosclerosis Stenosis (BAMUS-ICAS)
A study testing Submaximal balloon angioplasty in people with Ischemic Stroke, run by General Hospital of Shenyang Military Region at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Submaximal balloon angioplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 19 Feb 2025to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
General Hospital of Northern Theater Command
Shenyang, 110840
Zi-Ai Zhao, +862428897491, zhaoziai@hotmail.com
About this study
Official title: Balloon Angioplasty for Minor Unstable Stroke With IntraCranial Atherosclerosis Stenosis (BAMUS-ICAS): a Prospective, Randomized, Multi-center Study
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.
- Conditions
- Ischemic Stroke
- Being tested
- Submaximal balloon angioplasty
- Keywords
- stroke, Submaximal balloon angioplasty, early neurological deterioration, Intracranial atherosclerotic stenosis
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Submaximal balloon angioplastyProcedure or surgery
The goal of submaximal balloon angioplasty is to use the balloon to improve the stenosis of the criminal artery by more than 20%.
| Study group | Role | What they receive |
|---|---|---|
| SBA group | Experimental | Receiving SBA plus best medical therapy Receives: Procedure: Submaximal balloon angioplasty |
| Control group | No intervention | Receiving best medical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of early neurological deterioration (NIHSS score increase of 4 points or more)
Measured: at 24±8 hours
Secondary outcomes (13)
The decrease of NIHSS score
Measured: at 24±8 hours
The decrease of NIHSS score
Measured: at 10±2 days
Proportion of early neurological improvement (NIHSS score decline of 4 points or 0)
Measured: at 24±8 hours
Proportion of patients with modified Rankin Score 0 to 1
Measured: at 90±7 days
Proportion of patients with modified Rankin Score 0 to 2
Measured: at 90±7 days
Distribution of patients with modified Rankin Score
Measured: at 90±7 days
the occurence of stroke or other cardiovascular events
Measured: at 90±7 days
ischemic stroke in the culprit artery territory
Measured: at 90±7 days
Incidence of symptomatic intracranial hemorrhage (ECASS-III criteria)
Measured: at 24±8 hours
Proportion of occurrence of cerebral parenchymal hemorrhage types (PH1) and (PH2)
Measured: at 24±8 hours
Proportion of serious adverse events
Measured: at 24±8 hours
Proportion of all-cause deaths
Measured: at 10±2 days
Complications associated with endovascular therapy
Measured: at 24±8 hours, at 10±2 days, at 90±7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start19 Feb 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Shenyang Military Region
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui-Sheng Chen, General Hospital of Shenyang Military Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06763458
- Sponsor's protocol ID
- Y(2024)262
- Acronym
- BAMUS-ICAS
- Status last verified
- Apr 2026
- First submitted
- 22 Dec 2024
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balloon Angioplasty for Minor Unstable Stroke With IntraCranial Atherosclerosis Stenosis (BAMUS-ICAS): a Prospective, Randomized, Multi-center Study
- ClinicalTrials.gov ID
- NCT06763458
- Acronym / sponsor ID
- BAMUS-ICAS / Y(2024)262
- Conditions
- Ischemic Stroke
- Keywords
- stroke, Submaximal balloon angioplasty, early neurological deterioration, Intracranial atherosclerotic stenosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- General Hospital of Shenyang Military RegionUniversity, hospital or other
- Study start
- 19 Feb 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 8 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SBA group | Experimental | Procedure: Submaximal balloon angioplastyReceiving SBA plus best medical therapy |
| Control group | No intervention | –Receiving best medical therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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);
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Submaximal balloon angioplastyThe goal of submaximal balloon angioplasty is to use the balloon to improve the stenosis of the criminal artery by more than 20%. | Procedure or surgery | SBA group |
Primary outcome
Proportion of early neurological deterioration (NIHSS score increase of 4 points or more)
Time frame: at 24±8 hours
13 secondary outcomes
The decrease of NIHSS score
Time frame: at 24±8 hours
The decrease of NIHSS score
Time frame: at 10±2 days
Proportion of early neurological improvement (NIHSS score decline of 4 points or 0)
Time frame: at 24±8 hours
Proportion of patients with modified Rankin Score 0 to 1
Time frame: at 90±7 days
Proportion of patients with modified Rankin Score 0 to 2
Time frame: at 90±7 days
Distribution of patients with modified Rankin Score
Time frame: at 90±7 days
the occurence of stroke or other cardiovascular events
Time frame: at 90±7 days
ischemic stroke in the culprit artery territory
Time frame: at 90±7 days
Incidence of symptomatic intracranial hemorrhage (ECASS-III criteria)
Time frame: at 24±8 hours
Proportion of occurrence of cerebral parenchymal hemorrhage types (PH1) and (PH2)
Time frame: at 24±8 hours
Proportion of serious adverse events
Time frame: at 24±8 hours
Proportion of all-cause deaths
Time frame: at 10±2 days
Complications associated with endovascular therapy
Time frame: at 24±8 hours, at 10±2 days, at 90±7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Ischemic Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Recruiting
Biomarkers of Paired VNS
Stroke, Ischemic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Submaximal balloon angioplasty in people with Ischemic Stroke, run by General Hospital of Shenyang Military Region at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hui-Sheng Chen (+86-024-28897511, chszh@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of early neurological deterioration (NIHSS score increase of 4 points or more) (time frame: at 24±8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.