Symptomatic Intracranial Atherosclerotic StenosisDRBEYOND2NCT07830277
Drug-Coated Balloon vs Aggressive Medical Management for High-Risk Symptomatic Intracranial Atherosclerotic Stenosis
A study testing Drug-Coated Balloon Angioplasty and Aggressive Medical Management in people with Symptomatic Intracranial Atherosclerotic Stenosis, run by Beijing Tiantan Hospital at 2 sites in China.
Trial summary
DR.BEYOND-2 is an investigator-initiated, prospective, multicenter, randomized, open-label, blinded-endpoint, parallel-group clinical trial designed to evaluate the efficacy and safety of drug-coated balloon (DCB) angioplasty plus aggressive medical management compared with aggressive medical management alone in… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Symptomatic Intracranial Atherosclerotic Stenosis
- What is being tested?
- Drug-Coated Balloon Angioplasty and Aggressive Medical Management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 570 participants
- Where
- 2 sitesChina
- Study dates
- 1 Oct 2026to 1 Jun 2031
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years old, regardless of gender
- Patients with symptomatic ICAS caused by stenosis of a major intracranial artery (the degree of ischemic stroke with target vessel stenosis within 90 days before enrollment is required to be 70-99%, or the degree of transient ischemic attack with target vessel stenosis is required to be 80-99%), standardized drug management of at least one antithrombotic drug and/or vascular risk factors
- DSA or CTA confirmed that the stenosis degree of one main intracranial artery (internal carotid artery C4-C7 segment, middle cerebral artery M1 segment, vertebral artery V4 segment and basilar artery) was between 70% and 99% (measured by WASID method), and was corresponding to the clinical symptoms. The normal diameter of the proximal end of the target lesion was ≥ 2mm, and the length of the target lesion was ≤ 15mm
- If the target lesion is located in the anterior circulation system (C4-C7 of the internal carotid artery or M1 of the middle cerebral artery), it is required that there is hypoperfusion in the blood supply area of the target vessel (at least one of the following conditions is met): ①head CTP or PWI showed that CBF in the target vessel area decreased significantly (the lesion side decreased by more than 30% compared with the opposite side); ②Cerebral infarction with hemodynamic abnormalities confirmed by head CT or MRI (such as watershed infarction); ③ASITN/SIR collateral circulation score based on DSA<3 points)
- Those who voluntarily participated in the study and signed the informed consent
Who cannot join
- Serious calcification of target vessels, or serious distortion of target vessels or anatomical factors make it difficult for interventional instruments to be in place
- Severe stenosis or occlusion of extracranial or intracranial vessels in series at the proximal or distal end of the target vessel
- Major surgical operations have been performed in recent 3 weeks
- Cerebral hemorrhage, massive cerebral infarction (the infarct area is greater than 50% of the middle cerebral artery supply area; cerebellar infarction: the infarct diameter is greater than 3cm) and myocardial infarction have occurred in the past three months
- The target lesion has undergone stent implantation before
- Intracranial artery stenosis caused by non atherosclerotic lesions, including but not limited to: arterial dissection, moyamoya disease, vasculitis, radiation vascular disease or fibromuscular dysplasia
Show all 14Show fewer
- mRS score ≥ 3
- Patients with coagulation dysfunction
- Those who cannot tolerate anesthesia and anticoagulant drugs, are contraindicated or allergic to surgical drugs (paclitaxel, heparin, contrast agent, aspirin, clopidogrel, etc.), and are allergic to surgical instruments or operating devices
- Platelet (PLT<90×109/L),hematocrit (<30%), international normalized ratio (INR)>1.5, uncontrollable severe hypertension (systolic blood pressure>180mmHg or diastolic blood pressure>110mmHg),severe liver injury (ALT or AST more than 3 times the normal value), severe renal function injury (creatinine>3mg/dl,>265μmol/L),and severe insufficiency of other important organs such as heart and lung
- The subjects participated in other clinical trials and have not completed the follow-up or the researchers judged that the patients' compliance was poor and they were unable to complete the follow-up as required
- Pregnant or lactating women, or those who plan to become pregnant within one year
- The disease will cause difficulties in treatment and follow-up evaluation (such as dementia or mental disorders, cancer, infection, severe metabolic diseases), and it is speculated that the life expectancy of the participants is less than 3 years
- Other cases that clinicians think should be excluded
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Baotou Central Hospital
Baotou, Inner Mongolia, 014000
Changchun Jiang, MD, +8613347180510, 15848246828@163.com
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100010
About this study
Official title: Drug-coated Balloon for Endovascular Treatment Versus Aggressive Medical Management in High-Risk Symptomatic Intracranial Atherosclerotic Stenosis
DR.BEYOND-2 is an investigator-initiated, prospective, multicenter, randomized, open-label, blinded-endpoint, parallel-group clinical trial designed to evaluate the efficacy and safety of drug-coated balloon (DCB) angioplasty plus aggressive medical management compared with aggressive medical management alone in patients with high-risk symptomatic intracranial atherosclerotic stenosis (sICAS).
A total of 570 eligible patients will be randomized in a 1:1 ratio to the DCB group or the medical management group. Patients assigned to the DCB group will undergo DCB angioplasty in addition to aggressive medical management, with rescue stenting permitted when clinically necessary according to the study protocol. Patients assigned to the control group will receive aggressive medical management alone.
The primary endpoint is the composite of any stroke or death within 30 days after enrollment and ischemic stroke in the territory of the qualifying artery from day 31 through 1 year. Participants will be followed for up to 3 years to further evaluate recurrent ischemic events, vascular outcomes, functional outcomes, and long-term safety.
Read the detailed description
Symptomatic intracranial atherosclerotic stenosis (sICAS) is an important cause of ischemic stroke and recurrent cerebrovascular events. Although aggressive medical management is the standard treatment, patients with severe stenosis and high-risk clinical or hemodynamic features may remain at substantial risk of recurrent ischemic events. Previous randomized trials of intracranial stenting have raised concerns regarding periprocedural safety, whereas balloon angioplasty has shown potential benefit but may be limited by arterial dissection, elastic recoil, and restenosis. Drug-coated balloon angioplasty may provide an alternative endovascular strategy by combining luminal enlargement with local delivery of an antiproliferative agent while minimizing permanent intracranial implants.
DR.BEYOND-2 is an investigator-initiated, prospective, multicenter, randomized, open-label trial with blinded endpoint assessment. The study will enroll 570 patients with high-risk symptomatic intracranial atherosclerotic stenosis involving a major intracranial artery. Eligible patients must have had a recent ischemic stroke or transient ischemic attack attributable to the qualifying artery, severe intracranial stenosis, and prior treatment with at least one antithrombotic agent and/or guideline-based vascular risk-factor management. For anterior-circulation lesions, evidence of hemodynamic compromise is additionally required according to the protocol.
Participants will be randomly assigned in a 1:1 ratio to DCB angioplasty plus aggressive medical management or aggressive medical management alone. In the intervention group, DCB angioplasty will be performed using a submaximal angioplasty strategy. Rescue stenting may be used in cases of severe dissection, significant residual stenosis, or marked elastic recoil according to predefined procedural criteria.
Both treatment groups will receive standardized aggressive medical management, including antiplatelet therapy, lipid-lowering therapy, blood-pressure control, diabetes management, and management of other vascular risk factors. The medical regimen and risk-factor targets will be applied consistently across both treatment groups.
The primary endpoint is the composite of any stroke or death within 30 days after enrollment and ischemic stroke in the territory of the qualifying artery from day 31 through 1 year. Secondary outcomes include recurrent ischemic stroke or transient ischemic attack, target-vessel revascularization, hemorrhagic events, mortality, functional outcome, quality of life, and target-vessel restenosis. Exploratory outcomes include high-resolution magnetic resonance imaging changes of the target vessel and clinical and vascular outcomes through 3 years.
Participants will undergo scheduled follow-up at 7 days, 30 days, 3 months, 6 months, and 12 months, followed by assessments every 6 months through 3 years. The trial is designed to determine whether DCB-based endovascular treatment in addition to aggressive medical management can reduce recurrent cerebrovascular events while maintaining acceptable procedural safety in patients with high-risk sICAS.
- Being tested
- Drug-Coated Balloon Angioplasty, Aggressive Medical Management
- Keywords
- Intracranial atherosclerotic stenosis, Symptomatic intracranial atherosclerotic stenosis, Drug-coated balloon, Balloon angioplasty, Endovascular treatment, Aggressive medical management, Ischemic stroke
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug-Coated Balloon AngioplastyProcedure or surgery
Participants randomized to the experimental group will undergo intracranial drug-coated balloon angioplasty using a submaximal angioplasty strategy. Predilation with an uncoated balloon is performed before drug-coated balloon angioplasty. Rescue stenting is permitted when severe dissection, residual stenosis >50%, marked elastic recoil, or other protocol-defined conditions occur.
Aggressive Medical ManagementOther
Aggressive medical management will be provided to participants in both groups and includes antiplatelet therapy, intensive lipid-lowering treatment, blood pressure and glucose control, and management of other vascular risk factors. Aspirin 100 mg/day is administered throughout follow-up, with clopidogrel 75 mg/day during the first 90 days after enrollment. Alternative antiplatelet therapy may be used according to platelet function or CYP2C19 genotype when appropriate.
| Study group | Role | What they receive |
|---|---|---|
| Drug-Coated Balloon Angioplasty Plus Aggressive Medical Management | Experimental | Participants assigned to this group will undergo drug-coated balloon angioplasty in addition to aggressive medical management. Rescue stenting is permitted when clinically necessary according to predefined procedural criteria, including severe dissection, significant residual stenosis, or marked elastic recoil. Receives: Procedure: Drug-Coated Balloon Angioplasty |
| Aggressive Medical Management Alone | Active comparator | Participants assigned to this group will receive aggressive medical management alone, including standardized antiplatelet therapy and intensive management of vascular risk factors. Receives: Other: Aggressive Medical Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Any stroke or death within 30 days after enrollment and recurrence of ischemic stroke in the target vessel area within 30 days to 1 year after enrollment
Percentage of Participants With Any stroke or death within 30 days after enrollment and recurrence of ischemic stroke in the target vessel area within 30 days to 1 year after enrollment.
Measured: within 30 days after enrollment;within 30 days to 1 year after enrollment
Secondary outcomes (15)
Percentage of Participants With Any stroke or death within 30 days after enrollment
Percentage of Participants With Any stroke or death within 30 days after enrollment.
Measured: Within 30 days after enrollment
Percentage of Participants With Recurrent Ischemic Stroke in any region within 30 days to 1 year after enrollment
Recurrence of ischemic stroke in any region within 30 days to 1 year after enrollment.
Measured: Within 30 days to 1 year after enrollment
Percentage of Participants With Recurrent TIA in the Territory of the Qualifying Artery Within 1 Year After Enrollment
TIA recurrence in target vessel area within 1 year after enrollment.
Measured: Within 1 year after enrollment
Percentage of Participants With Recurrent TIA in Any Vascular Territory Within 1 Year After Enrollment
TIA recurrence in any region within 1 year after enrollment.
Measured: Within 1 year after enrollment
Percentage of Participants Undergoing Target-Vessel Revascularization Within 1 Year After Enrollment
Salvage revascularization of target vessels within 1 year after enrollment (mechanical thrombectomy/arterial thrombolysis/angioplasty/vascular bypass).
Measured: Within 1 year after enrollment
Percentage of Participants With Coronary Ischemic Events Within 1 Year After Enrollment
Coronary ischemic events within 1 year after enrollment (including myocardial infarction or angina pectoris).
Measured: Within 1 year after enrollment
Modified Rankin Scale (mRS) Score at 1 Year (±1 Month) After Enrollment
The modified Rankin scale (mRS) ranged from 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability,5 severe disability, and 6 death.
Measured: 1 year (± 1 month) after enrollment
EQ-5D Score at 1 Year (±1 Month) After Enrollment
The change in functional health status and quality of life measured by EuroQol five dimensions questionnaire (EQ-5D) at 1 year (± 1 month) after enrollment.
Measured: 1 year (± 1 month) after enrollment
Percentage of Participants With Target-Vessel Restenosis at 1 Year (±1 Month) After Enrollment in the Experimental Group
Target vessel restenosis at 1 year (±1 month) after enrollment (experimental group only, evaluated by CTA).
Measured: 1 year (±1 month) after enrollment
Percentage of Participants With Symptomatic Target-Vessel Restenosis at 1 Year (±1 Month) After Enrollment in the Experimental Group
Symptomatic restenosis of target vessels at 1 year (± 1 month) after enrollment (evaluation of the experimental group only).
Measured: 1 year (±1 month) after enrollment
Percentage of Participants With Hemorrhagic Stroke Within 1 Year After Enrollment
Hemorrhagic stroke within 1 year after enrollment (cerebral hemorrhage, subarachnoid hemorrhage, intraventricular hemorrhage, etc.).
Measured: Within 1 year after enrollment
Percentage of Participants With Extracranial Hemorrhage Within 1 Year After Enrollment
Extracranial hemorrhage within 1 year after enrollment (gastrointestinal bleeding, hematuria, epistaxis or fundus hemorrhage, etc.).
Measured: Within 1 year after enrollment
Percentage of Participants With All-Cause Mortality Within 1 Year After Enrollment
All cause death within 1 year after enrollment.
Measured: Within 1 year after enrollment
Percentage of Participants With Stroke-Related Mortality Within 1 Year After Enrollment
Stroke related death within 1 year after enrollment.
Measured: Within 1 year after enrollment
Percentage of Participants With Other Serious Adverse Events Within 1 Year After Enrollment
Other serious adverse events within 1 year after enrollment.
Measured: Within 1 year after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion1 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Intracranial Atherosclerotic StenosisStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 570 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Baotou Central Hospital
- Responsible party
- Principal investigator, Dapeng Mo, Beijing Tiantan Hospital
- Investigators
- Changchun Jiang, MD, Principal investigator, Baotou Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07830277
- Sponsor's protocol ID
- HX-A-2026071-001
- Acronym
- DRBEYOND2
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 23 Sep 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 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug-coated Balloon for Endovascular Treatment Versus Aggressive Medical Management in High-Risk Symptomatic Intracranial Atherosclerotic Stenosis
- ClinicalTrials.gov ID
- NCT07830277
- Acronym / sponsor ID
- DRBEYOND2 / HX-A-2026071-001
- Keywords
- Intracranial atherosclerotic stenosis, Symptomatic intracranial atherosclerotic stenosis, Drug-coated balloon, Balloon angioplasty, Endovascular treatment, Aggressive medical management, Ischemic stroke
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 570 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- Baotou Central Hospital
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 1 Jun 2031 (estimated)
- First posted
- 21 Sep 2026 (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.
DR.BEYOND-2 is an investigator-initiated, prospective, multicenter, randomized, open-label, blinded-endpoint, parallel-group clinical trial designed to evaluate the efficacy and safety of drug-coated balloon (DCB) angioplasty plus aggressive medical management compared with aggressive medical management alone in patients with high-risk symptomatic intracranial atherosclerotic stenosis (sICAS).
A total of 570 eligible patients will be randomized in a 1:1 ratio to the DCB group or the medical management group. Patients assigned to the DCB group will undergo DCB angioplasty in addition to aggressive medical management, with rescue stenting permitted when clinically necessary according to the study protocol. Patients assigned to the control group will receive aggressive medical management alone.
The primary endpoint is the composite of any stroke or death within 30 days after enrollment and ischemic stroke in the territory of the qualifying artery from day 31 through 1 year. Participants will be followed for up to 3 years to further evaluate recurrent ischemic events, vascular outcomes, functional outcomes, and long-term safety.
Detailed description
Symptomatic intracranial atherosclerotic stenosis (sICAS) is an important cause of ischemic stroke and recurrent cerebrovascular events. Although aggressive medical management is the standard treatment, patients with severe stenosis and high-risk clinical or hemodynamic features may remain at substantial risk of recurrent ischemic events. Previous randomized trials of intracranial stenting have raised concerns regarding periprocedural safety, whereas balloon angioplasty has shown potential benefit but may be limited by arterial dissection, elastic recoil, and restenosis. Drug-coated balloon angioplasty may provide an alternative endovascular strategy by combining luminal enlargement with local delivery of an antiproliferative agent while minimizing permanent intracranial implants.
DR.BEYOND-2 is an investigator-initiated, prospective, multicenter, randomized, open-label trial with blinded endpoint assessment. The study will enroll 570 patients with high-risk symptomatic intracranial atherosclerotic stenosis involving a major intracranial artery. Eligible patients must have had a recent ischemic stroke or transient ischemic attack attributable to the qualifying artery, severe intracranial stenosis, and prior treatment with at least one antithrombotic agent and/or guideline-based vascular risk-factor management. For anterior-circulation lesions, evidence of hemodynamic compromise is additionally required according to the protocol.
Participants will be randomly assigned in a 1:1 ratio to DCB angioplasty plus aggressive medical management or aggressive medical management alone. In the intervention group, DCB angioplasty will be performed using a submaximal angioplasty strategy. Rescue stenting may be used in cases of severe dissection, significant residual stenosis, or marked elastic recoil according to predefined procedural criteria.
Both treatment groups will receive standardized aggressive medical management, including antiplatelet therapy, lipid-lowering therapy, blood-pressure control, diabetes management, and management of other vascular risk factors. The medical regimen and risk-factor targets will be applied consistently across both treatment groups.
The primary endpoint is the composite of any stroke or death within 30 days after enrollment and ischemic stroke in the territory of the qualifying artery from day 31 through 1 year. Secondary outcomes include recurrent ischemic stroke or transient ischemic attack, target-vessel revascularization, hemorrhagic events, mortality, functional outcome, quality of life, and target-vessel restenosis. Exploratory outcomes include high-resolution magnetic resonance imaging changes of the target vessel and clinical and vascular outcomes through 3 years.
Participants will undergo scheduled follow-up at 7 days, 30 days, 3 months, 6 months, and 12 months, followed by assessments every 6 months through 3 years. The trial is designed to determine whether DCB-based endovascular treatment in addition to aggressive medical management can reduce recurrent cerebrovascular events while maintaining acceptable procedural safety in patients with high-risk sICAS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug-Coated Balloon Angioplasty Plus Aggressive Medical Management | Experimental | Procedure: Drug-Coated Balloon AngioplastyParticipants assigned to this group will undergo drug-coated balloon angioplasty in addition to aggressive medical management. Rescue stenting is permitted when clinically necessary according to predefined procedural criteria, including severe dissection, significant residual stenosis, or marked elastic recoil. |
| Aggressive Medical Management Alone | Active comparator | Other: Aggressive Medical ManagementParticipants assigned to this group will receive aggressive medical management alone, including standardized antiplatelet therapy and intensive management of vascular risk factors. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-80 years old, regardless of gender
- Patients with symptomatic ICAS caused by stenosis of a major intracranial artery (the degree of ischemic stroke with target vessel stenosis within 90 days before enrollment is required to be 70-99%, or the degree of transient ischemic attack with target vessel stenosis is required to be 80-99%), standardized drug management of at least one antithrombotic drug and/or vascular risk factors
- DSA or CTA confirmed that the stenosis degree of one main intracranial artery (internal carotid artery C4-C7 segment, middle cerebral artery M1 segment, vertebral artery V4 segment and basilar artery) was between 70% and 99% (measured by WASID method), and was corresponding to the clinical symptoms. The normal diameter of the proximal end of the target lesion was ≥ 2mm, and the length of the target lesion was ≤ 15mm
- If the target lesion is located in the anterior circulation system (C4-C7 of the internal carotid artery or M1 of the middle cerebral artery), it is required that there is hypoperfusion in the blood supply area of the target vessel (at least one of the following conditions is met): ①head CTP or PWI showed that CBF in the target vessel area decreased significantly (the lesion side decreased by more than 30% compared with the opposite side); ②Cerebral infarction with hemodynamic abnormalities confirmed by head CT or MRI (such as watershed infarction); ③ASITN/SIR collateral circulation score based on DSA<3 points)
- Those who voluntarily participated in the study and signed the informed consent
Key exclusion criteria (14 listed)
- Serious calcification of target vessels, or serious distortion of target vessels or anatomical factors make it difficult for interventional instruments to be in place
- Severe stenosis or occlusion of extracranial or intracranial vessels in series at the proximal or distal end of the target vessel
- Major surgical operations have been performed in recent 3 weeks
- Cerebral hemorrhage, massive cerebral infarction (the infarct area is greater than 50% of the middle cerebral artery supply area; cerebellar infarction: the infarct diameter is greater than 3cm) and myocardial infarction have occurred in the past three months
- The target lesion has undergone stent implantation before
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 |
|---|---|---|
| Drug-Coated Balloon AngioplastyParticipants randomized to the experimental group will undergo intracranial drug-coated balloon angioplasty using a submaximal angioplasty strategy. Predilation with an uncoated balloon is performed before drug-coated balloon angioplasty. Rescue stenting is permitted when severe dissection, residual stenosis >50%, marked elastic recoil, or other protocol-defined conditions occur. | Procedure or surgery | Drug-Coated Balloon Angioplasty Plus Aggressive Medical Management |
| Aggressive Medical ManagementAggressive medical management will be provided to participants in both groups and includes antiplatelet therapy, intensive lipid-lowering treatment, blood pressure and glucose control, and management of other vascular risk factors. Aspirin 100 mg/day is administered throughout follow-up, with clopidogrel 75 mg/day during the first 90 days after enrollment. Alternative antiplatelet therapy may be used according to platelet function or CYP2C19 genotype when appropriate. | Other | Aggressive Medical Management Alone |
Primary outcome
Percentage of Participants With Any stroke or death within 30 days after enrollment and recurrence of ischemic stroke in the target vessel area within 30 days to 1 year after enrollment
Time frame: within 30 days after enrollment;within 30 days to 1 year after enrollment
Percentage of Participants With Any stroke or death within 30 days after enrollment and recurrence of ischemic stroke in the target vessel area within 30 days to 1 year after enrollment.
15 secondary outcomes
Percentage of Participants With Any stroke or death within 30 days after enrollment
Time frame: Within 30 days after enrollment
Percentage of Participants With Recurrent Ischemic Stroke in any region within 30 days to 1 year after enrollment
Time frame: Within 30 days to 1 year after enrollment
Percentage of Participants With Recurrent TIA in the Territory of the Qualifying Artery Within 1 Year After Enrollment
Time frame: Within 1 year after enrollment
Percentage of Participants With Recurrent TIA in Any Vascular Territory Within 1 Year After Enrollment
Time frame: Within 1 year after enrollment
Percentage of Participants Undergoing Target-Vessel Revascularization Within 1 Year After Enrollment
Time frame: Within 1 year after enrollment
Percentage of Participants With Coronary Ischemic Events Within 1 Year After Enrollment
Time frame: Within 1 year after enrollment
Modified Rankin Scale (mRS) Score at 1 Year (±1 Month) After Enrollment
Time frame: 1 year (± 1 month) after enrollment
EQ-5D Score at 1 Year (±1 Month) After Enrollment
Time frame: 1 year (± 1 month) after enrollment
Percentage of Participants With Target-Vessel Restenosis at 1 Year (±1 Month) After Enrollment in the Experimental Group
Time frame: 1 year (±1 month) after enrollment
Percentage of Participants With Symptomatic Target-Vessel Restenosis at 1 Year (±1 Month) After Enrollment in the Experimental Group
Time frame: 1 year (±1 month) after enrollment
Percentage of Participants With Hemorrhagic Stroke Within 1 Year After Enrollment
Time frame: Within 1 year after enrollment
Percentage of Participants With Extracranial Hemorrhage Within 1 Year After Enrollment
Time frame: Within 1 year after enrollment
Percentage of Participants With All-Cause Mortality Within 1 Year After Enrollment
Time frame: Within 1 year after enrollment
Percentage of Participants With Stroke-Related Mortality Within 1 Year After Enrollment
Time frame: Within 1 year after enrollment
Percentage of Participants With Other Serious Adverse Events Within 1 Year After Enrollment
Time frame: Within 1 year after enrollment
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 23 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Changchun Jiang, MD principal investigator
Baotou Central Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drug-Coated Balloon Angioplasty and Aggressive Medical Management in people with Symptomatic Intracranial Atherosclerotic Stenosis, run by Beijing Tiantan Hospital at 2 sites 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 5 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: opening soon, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Changchun Jiang, MD (13347180510, 15848246828@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Any stroke or death within 30 days after enrollment and recurrence of ischemic stroke in the target vessel area within 30 days to 1 year after enrollment (time frame: within 30 days after enrollment;within 30 days to 1 year after enrollment). 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 23 Sep 2026.