An interventional study of Drug therapy administration and Intracranial artery balloon dilatation combined with intensive medical treatment in Intracranial Atherosclerotic Stenosis, sponsored by Beijing Tiantan Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Beijing Tiantan Hospital · Not applicable, Interventional, and Treatment
This study is a prospective, multicenter, randomized, open, parallel controlled clinical study initiated by researchers. The included population was patients with ischemic stroke. The primary end point was any new stroke (ischemic/hemorrhagic stroke) within 30 days after admission and all-cause death or ischemic stroke in the target vascular supply area within 31 days to 12 months after admission.
The main purpose of this study was to evaluate whether intracranial drug-eluting balloon angioplasty is superior to intensive medical treatment alone in the treatment of stroke and death within 30 days or ischemic stroke in the target vessel area within 31 days to 1 year in patients with symptomatic intracranial artery stenosis.
Symptomatic intracranial atherosclerotic stenosis (sICAS) is an important cause of ischemic stroke and recurrent cerebrovascular events. Although active drug management is the standard treatment, patients with severe stenosis and high-risk clinical or hemodynamic characteristics may still face a higher risk of recurrent ischemic events. Previous randomized trials of intracranial stent implantation raised concerns about the perioperative safety; although balloon angioplasty shows potential benefits, it may be limited by arterial dissection, elastic retraction and restenosis. Drug-coated balloon angioplasty can provide an alternative endovascular treatment strategy by combining lumen expansion with local delivery of antiproliferative drugs, while minimizing permanent intracranial implants.
The included population was patients with acute ischemic stroke. Within 30 days of onset, the disease was caused by symptomatic intracranial atherosclerosis with stenosis of one main intracranial artery (including anterior circulation and posterior circulation) and stenosis degree of 70-99%. The lesions of anterior and posterior circulation included the end of internal carotid artery (C4-C7 segment), middle cerebral artery M1 segment, vertebral artery V4 segment and basilar artery. According to the ratio of 1:1, the subjects were randomly included in the experimental group/control group.
Beijing Tiantan Hospital is the lead sponsor of 490 studies on the registry; 294 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
1)Ischemic stroke still occurred after intensive medical treatment 2)Brain perfusion CT showed that the cerebral blood flow decreased by ≥ 30% in anterior circulation lesions compared with contralateral cerebral perfusion and posterior circulation lesions compared with ipsilateral anterior circulation 3)Under digital subtraction angiography (DSA), the American Society of Interventional and Therapeutic Neuroradiology/Society of Interventional Radiology (ASITN/SIR) score was less than 3 points 4)Brain magnetic resonance imaging (MRI) showed hemodynamic ischemic lesions 5)Single photon emission computed tomography (SPECT) showed cerebral hypoperfusion 5.mRS ≤ 1 point before onset 6.Study population who voluntarily participated in the study and signed the
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Drug therapy administration
Procedure: Intracranial artery balloon dilatation combined with intensive medical treatment
Aspirin 100 mg daily for the entire follow-up period after enrollment. Clopidogrel 75 mg daily for the first 90 days after enrollment; continuation of clopidogrel beyond day 90 will be based on clinical status. For patients with known clopidogrel resistance, switching to ticagrelor may be considered at the investigator's discretion. Atorvastatin calcium 20-80 mg daily for the first year after enrollment; dose titration to achieve LDL-C \<1.8 mmol/L (\<70 mg/dL). Continuation of atorvastatin after 1 year will be determined by individual clinical circumstances. Risk Factor Modification Blood pressure will be maintained at 130-140 / 90-100 mmHg, with LDL-C targeted to \<1.8 mmol/L (\<70 mg/dL); Diabetes mellitus management;Smoking cessation;weight Management;physical activity and non-high-density lipoprotein cholesterol management.
Participants randomly assigned to the experimental group will receive intracranial drug coated balloon angioplasty combined with enhanced internal medicine treatment. Prior to intracranial drug coated balloon angioplasty, an uncoated balloon is used for pre dilation. If the residual stenosis rate is ≥ 70%, or if the forward blood flow is unstable with mTICI\<2b, if there is a dissection at the lesion site, and if the distal blood flow is unstable with mTICI\<2b, or if other conditions specified by the protocol occur, stents may be used as appropriate for remediation.
Any new stroke (ischemic/hemorrhagic stroke) and all-cause death within 30 days after enrollment or ischemic stroke in the target blood supply area within 31 days to 12 months after enrollment
Any new stroke (ischemic/hemorrhagic stroke) and all-cause death within 30 days after enrollment or ischemic stroke in the target blood supply area within 31 days to 12 months after enrollment
Time frame: Within 30 days after enrollment;Within 12 months after enrollment
Any stroke (ischemic/hemorrhagic stroke) and all-cause death within 30 days after enrollment
Any stroke (ischemic/hemorrhagic stroke) and all-cause death within 30 days after enrollment.
Time frame: Within 30 days after enrollment
Any stroke (hemorrhagic/ischemic stroke) or death in the target vessel supply area within 90 days of enrollment
Any stroke (hemorrhagic/ischemic stroke) or death in the target vessel supply area within 90 days of enrollment.
Time frame: Within 90 days of enrollment
Any stroke (hemorrhagic/ischemic stroke) outside the target blood supply area within 90 days of enrollment
Any stroke (hemorrhagic/ischemic stroke) outside the target blood supply area within 90 days of enrollment.
Time frame: Within 90 days of enrollment
Assessment of neurological function improvement within 90 days of enrollment (mRS score)
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.
Time frame: Within 90 days of enrollment
Assessment of neurological function improvement within 180 days of enrollment (mRS score)
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.
Time frame: Within 180 days of enrollment
Any stroke (hemorrhagic/ischemic stroke) or death in the target vascular supply area within 12 months of enrollment
Any stroke (hemorrhagic/ischemic stroke) or death in the target vascular supply area within 12 months of enrollment.
Time frame: Within 12 months of enrollment
Target vessel revascularization within 12 months of enrollment
Target vessel revascularization within 12 months of enrollment.
Time frame: Within 12 months of enrollment
Any stroke (hemorrhagic/ischemic stroke) outside the target blood supply area within 12 months of enrollment
Any stroke (hemorrhagic/ischemic stroke) outside the target blood supply area within 12 months of enrollment.
Time frame: Within 12 months of enrollment
Assessment of neurological function improvement within 12 months of enrollment (mRS score)
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.
Time frame: Within 12 months of enrollment
The incidence of vascular restenosis within 12 months of enrollment
The incidence of vascular restenosis within 12 months of enrollment.
Time frame: Within 12 months of enrollment
Composite events such as stroke, myocardial infarction, and vascular death within 12 months of enrollment
Composite events such as stroke, myocardial infarction, and vascular death within 12 months of enrollment.
Time frame: Within 12 months of enrollment
Quality of life assessment within 12 months of enrollment (EQ-5D scale)
The change in functional health status and quality of life measured by EuroQol five dimensions questionnaire (EQ-5D) within 12 months of enrollment.
Time frame: Within 12 months of enrollment
Any stroke (hemorrhagic/ischemic stroke) or death in the target vascular supply area within 24 months of enrollment
Any stroke (hemorrhagic/ischemic stroke) or death in the target vascular supply area within 24 months of enrollment.
Time frame: Within 24 months of enrollment
Any stroke (hemorrhagic/ischemic stroke) outside the target blood supply area within 24 months of enrollment
Any stroke (hemorrhagic/ischemic stroke) outside the target blood supply area within 24 months of enrollment.
Time frame: Within 24 months of enrollment
Assessment of neurological function improvement within 24 months of enrollment (mRS score)
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.
Time frame: Within 24 months of enrollment
Composite events such as stroke, myocardial infarction, and vascular death within 24 months of enrollment
Composite events such as stroke, myocardial infarction, and vascular death within 24 months of enrollment.
Time frame: Within 24 months of enrollment
Any stroke (hemorrhagic/ischemic stroke) or death in the target vascular supply area within 36 months of enrollment
Any stroke (hemorrhagic/ischemic stroke) or death in the target vascular supply area within 36 months of enrollment.
Time frame: Within 36 months of enrollment
Any stroke (hemorrhagic/ischemic stroke) outside the target vascular supply area within 36 months of enrollment
Any stroke (hemorrhagic/ischemic stroke) outside the target vascular supply area within 36 months of enrollment.
Time frame: Within 36 months of enrollment
Assessment of neurological function improvement within 36 months of enrollment (mRS score)
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.
Time frame: Within 36 months of enrollment
Composite events such as stroke, myocardial infarction, and vascular death within 36 months of enrollment
Composite events such as stroke, myocardial infarction, and vascular death within 36 months of enrollment.
Time frame: Within 36 months of enrollment
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Dec 2029, 37 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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