Ischemic StrokeNCT06014723
Balloon angiopLasty for Intracranial Atherosclerotic Minor Stroke/TIA
An observational study of Ischemic Stroke, run by Shouchun Wang, MD, PhD at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Submaximal balloon angioplasty
- Type of treatment
- Surgery or procedure
- How many people
- 416 participants
- Where
- 1 siteChina
- Study dates
- 23 Aug 2023to 1 Dec 2026
- Phase
- Observational
- 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 30 to 80 years
- All sexes
- Adult, Older adult
Study population: Patients with minor stroke/transient ischemic attack.
Who may be able to join
- age range of 30-80 years;
- 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;
- 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;
- diameter of the culprit artery ranging from 2.0 to 4.5mm, and the length of the stenosis≤14mm;
- mRS ≤ 2 before endovascular treatment；
- no large ischemic region found on CT or MRI (ASPECTS≥ 6 or pc-ASPECTS ≥8)；
- written informed consent obtained from the patient or legally responsible person.
Who cannot join
- allergy to contrast media;
- non-atherosclerotic disease-related stenosis, such as arterial dissection, Moya-Moya disease, and arteritis;
- 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);
- presence of severe stenosis of the extracranial segment on the side of the target lesion;
- previous endovascular treatment of the ipsilateral vessel;
- presence of intracranial aneurysms, tumors, and vascular malformations;
Show all 14Show fewer
- any form of ipsilateral intracranial hemorrhage within 3 months and contralateral intracranial hemorrhage within 2 weeks;
- presence of atrial fibrillation, severe heart dysfunction, liver or kidney dysfunction; patients with tumors and serious diseases whose expected survival time is ≤ 1 year;
- hemoglobin ≤ 100g/L, platelet count ≤ 100×10^9/L, INR> 1.5 (irreversible), coagulopathy or irremediable bleeding factors;
- uncontrollable hypertension: systolic blood pressure >185 mmHg and/or diastolic blood pressure >110 mmHg;
- poor glycemic control (random blood glucose > 22.2 mmol/L);
- history of major surgery within 30 days prior to enrollment or surgery plan within 90 days after enrollment;
- pregnancy or lactation;
- other conditions that the researchers think make the patient unsuitable for the 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
The First Hospital of Jilin University
Changchun, Jilin, 130000
Shouchun MD Wang, MD,PhD, 13596060906 ext. 0086, WSC@jlu.edu.cn
About this study
Official title: Balloon angiopLasty for Intracranial Atherosclerotic Minor Stroke/TIA: a Prospective, Multi-center, Register Study
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.
Read the 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.
- Conditions
- Ischemic Stroke
- Being tested
- Submaximal balloon angioplasty
- Medical subject headings
- Ischemic 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 |
|---|---|---|
| Observation group | The observation group received early submaximal balloon angioplasty and medical therapy. Receives: Procedure: Submaximal balloon angioplasty | |
| Control group | The control group received only medical therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke or death within 30 days or ischemic stroke in the culprit artery territory from 30 days to 1 year
Stroke or death within 30 days or ischemic stroke in the culprit artery territory from 30 days to 1 year
Measured: 30 days, 1 year
Secondary outcomes (4)
Stroke or death within 30 days after enrollment
Stroke or death within 30 days after enrollment
Measured: 30 days
Ischemic stroke in the territory of criminal artery from 30 days to 1 year after enrollment
Ischemic stroke in the territory of criminal artery from 30 days to 1 year after enrollment
Measured: 1 year
Restenosis rate of criminal artery within 1 year after enrollment
Restenosis rate of criminal artery within 1 year after enrollment
Measured: 1 year
Evaluation of neurological function improvement within 90 days of enrollment
Evaluation of neurological function improvement within 90 days of enrollment
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start23 Aug 2023
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 416 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shouchun Wang, MD, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- The General Hospital of Northern Theater Command
- Responsible party
- Sponsor-investigator, Shouchun Wang, MD, PhD, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06014723
- Sponsor's protocol ID
- BLAST
- Status last verified
- Jan 2024
- First submitted
- 21 Aug 2023
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Qi S, Liu L, Yue FX, Qiu J, Li W, Li C, Nguyen TN, Wei M, Chen HS, Wang SC. Balloon angiopLasty for intracranial Atherosclerotic minor Stroke/TIA (BLAST): study protocol for a multicenter prospective cohort study. Front Neurol. 2024 May 24;15:1385546. doi: 10.3389/fneur.2024.1385546. eCollection 2024.
PubMed 38854963
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balloon angiopLasty for Intracranial Atherosclerotic Minor Stroke/TIA: a Prospective, Multi-center, Register Study
- ClinicalTrials.gov ID
- NCT06014723
- Acronym / sponsor ID
- BLAST
- Conditions
- Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 416 participants (estimated)
- Lead sponsor
- Shouchun Wang, MD, PhDUniversity, hospital or other
- Collaborators
- The General Hospital of Northern Theater Command
- Study start
- 23 Aug 2023 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 28 Aug 2023 (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.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observation group | – | Procedure: Submaximal balloon angioplastyThe observation group received early submaximal balloon angioplasty and medical therapy. |
| Control group | – | –The control group received only medical therapy. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with minor stroke/transient ischemic attack.
Key inclusion criteria (7 listed)
- age range of 30-80 years;
- 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;
- 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;
- diameter of the culprit artery ranging from 2.0 to 4.5mm, and the length of the stenosis≤14mm;
- mRS ≤ 2 before endovascular treatment；
Key exclusion criteria (14 listed)
- allergy to contrast media;
- non-atherosclerotic disease-related stenosis, such as arterial dissection, Moya-Moya disease, and arteritis;
- 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);
- presence of severe stenosis of the extracranial segment on the side of the target lesion;
- previous endovascular treatment of the ipsilateral vessel;
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 | Observation group |
Primary outcome
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
4 secondary outcomes
Stroke or death within 30 days after enrollment
Time frame: 30 days
Ischemic stroke in the territory of criminal artery from 30 days to 1 year after enrollment
Time frame: 1 year
Restenosis rate of criminal artery within 1 year after enrollment
Time frame: 1 year
Evaluation of neurological function improvement within 90 days of enrollment
Time frame: 90 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 3 Jan 2024.
- Derived from this study: PubMed 38854963Qi S, Liu L, Yue FX, Qiu J, Li W, Li C, Nguyen TN, Wei M, Chen HS, Wang SC. Balloon angiopLasty for intracranial Atherosclerotic minor Stroke/TIA (BLAST): study protocol for a multicenter prospective cohort study. Front Neurol. 2024 May 24;15:1385546. doi: 10.3389/fneur.2024.1385546. eCollection 2024.
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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?
An observational study of Ischemic Stroke, run by Shouchun Wang, MD, PhD 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 14 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 3 Jan 2024. 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 Shouchun Wang, MD, PhD (0086-13596060906, WSC@jlu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06014723, which also lists 1 linked publication.
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 3 Jan 2024.