ICAD - Intracranial Atherosclerotic DiseaseDREAM-PRIDENCT04948749
Drug Eluting Stenting and Aggressive Medical Treatment for Preventing Recurrent Stroke in Intracranial Atherosclerotic Disease Trial
A study testing Drug Eluting Stent implantation, Aggressive medical treatment and Risk factor management in people with ICAD - Intracranial Atherosclerotic Disease and ICAS - Intracranial Atherosclerosis, run by Beijing Tiantan Hospital at 18 sites in China.
Trial summary
The aim of DREAM-PRIDE is to evaluate whether implantation of drug-eluting stent (DES) combined with aggressive medical treatment is more efficacious in prevention of 1-year stroke recurrence than standard medical treatment alone for symptomatic intracranial atherosclerotic disease. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- ICAD - Intracranial Atherosclerotic Disease, ICAS - Intracranial Atherosclerosis, Drug-eluting Stent
- What is being tested?
- Drug Eluting Stent implantation, Aggressive medical treatment and Risk factor management
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 358 participants
- Where
- 18 sitesChina
- Study dates
- 2 Jul 2021to 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18 to 85 years
- Patients with ischemic stroke within 30 days of enrolment attributed to 70% to 99% stenosis of a major intracranial artery (internal carotid artery [C5-C7], middle cerebral artery [M1], vertebral artery [V4], or basilar artery) on CTA (According to WASID method)
- The diameter of the target vessel between 2.0mm - 4.5mm
- The stenosis lesion length ≤ 14 mm
- Baseline modified Rankin Scale (mRS) score ≤ 3
- Patient understands the purpose and requirements of the study, and has provided informed consent
Who cannot join
- Ischemic stroke occurred within 7 days before enrolment
- Tandem extracranial or intracranial stenosis (70%-99%) or occlusion that is proximal or distal to the target intracranial lesion (NOTE: an exception is allowed if stenosis or occlusion involves a single vertebral artery proximal to a symptomatic basilar artery stenosis and the contralateral vertebral artery is supplying the basilar artery)
- Bilateral intracranial vertebral artery stenosis of 70%-99% and uncertainty about which artery is symptomatic (NOTE: an exception is that if bilateral vertebral arteries with 70%-99% stenosis but unequal in size, the dominant side is considered as symptomatic)
- Unilateral vertebral artery stenosis of 70%-99% with normal contralateral vertebral artery
- Stroke caused by perforating artery occlusion
- CT angiographic evidence of severe calcification at target lesion
Show all 23Show fewer
- Any history of brain parenchymal or subarachnoid, subdural or extradural haemorrhage in the past 6 weeks
- Intracranial artery stenosis caused by non-atherosclerotic lesions, including: arterial dissection, Moyamoya disease, vasculitis disease, herpes zoster, varicella-zoster or other viral vascular diseases, neurosyphilis, any other intracranial infections, any intracranial stenosis related to cerebrospinal fluid cells, radiation-induced vascular disease, fibromuscular dysplasia, sickle cell disease, neurofibromatosis, central nervous system benign vascular disease, postpartum vascular disease, suspected vasospasm, suspicious embolism recanalization, etc
- History of stenting of an intracranial artery
- Presence of any unequivocal cardiac source of embolism
- Combined with intracranial tumor, aneurysm or intracranial arteriovenous malformation
- Cannot tolerate dual antiplatelet therapy
- Contraindications to heparin, rapamycin, contrast and local or general anesthesia
- Hemoglobin<100g/L, platelet count <100×109/L
- Severe hepatic and renal dysfunction
- INR>1.5 or there are uncorrectable factors leading to bleeding
- Major surgery within the past 30 days or planned within 90 days
- Renal artery, iliac artery, and coronary artery requiring simultaneous intervention
- Life expectancy <1 year
- Pregnant or lactating women
- Cannot complete the follow-up due to cognitive, emotional or mental illness
- Other situations that are not suitable for enrolment according to the judgement of the investigator
- Enrolment in another study that would conflict with the current study
Trial locations and contacts
18 sites in 1 country. Contact the study team or a site near you to ask about taking part.
18 sites in 1 country
China18 sites, 18 recruiting
- Recruiting
Baotou Central Hospital
Baotou, Inner Mongolia
Changchun Jiang, 86+13347180510, 13347180510@163.com
Changchun Jiang
- Recruiting
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100070
Zhongrong Miao, MD, 13601243293, 13601243293@163.com
- Recruiting
Beijing Daxing District People's Hospital
Beijing, Beijing Municipality
Jinglin Yuan, 86+13426252069, yuanjl3344@126.com
Jinglin Yuan
- Recruiting
General Hospital of Benxi Iron and Steel Co
Benxi, Liaoning
Qian Wang, 86+13941431375, bgzywq5257@163.com
- Recruiting
Hejian People's Hospital
Cangzhou, Hebei
Dong Sun, 18632768855, 18632768855@163.com
Dong Sun
- Recruiting
The Second Norman Bethune Hospital of JilinUniversity,
Changchun, Jilin
Long Yan, 86+15543686866, yanlong101@jlu.edu.cn
Long Yan
- Recruiting
The First Affiliated Hospital of College of Medicine
Hangzhou, Zhejiang
Ziqi Xu, 86+13858192341, zyxuziqi@zju.edu.cn
Ziqi Xu
- Recruiting
Inner Mongolia Autonomous Region People's Hospital
Hohhot, Inner Mongolia
Rile Wu, 86+15326000666, wurile@hotmail.com
Rile Wu
- Recruiting
Lishui People's Hospital
Lishui, Zhejiang
Lin Xiang, 86+18957091688, 61365310@qq.com
Lin Xiang
- Recruiting
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu
Guibing Ding, 86+1377666937, yuxiazaizai@126.com
Guibing Ding
- Recruiting
Beilun People's Hospital of Ningbo City
Ningbo, Zhejiang
Xing Fang, 86+13567432657, 58189633@qq.com
Xing Fang
- Recruiting
Shanxi Cardiovascular Hospital
Taiyuan, Shanxi
Dong Kuai, 86+13835172104, kuaidong12345@163.com
Dong Kuai
- Recruiting
Shanxi Provincial People's Hospital
Taiyuan, Shanxi
Yaxuan Sun, 86+13834578394, rvlm@163.com
Yaxuan Sun
- Recruiting
North China University of Science and Technology Affiliated Hospital
Tangshan, Hebei
Chengjing Xue, 86+15130567788, 506944567@qq.com
Chengjing Xue
- Recruiting
Tongliao City Hospital
Tongliao, Inner Mongolia
Peng Xu, 18347588080, doujiaogaibei@163.com
Peng Xu
- Recruiting
Wuhai People's Hospital
Wuhai, Inner Mongolia
Hu Shen, 86+13848309996, shenhu168@yeah.net
Hu Shen
- Recruiting
General Hospital of The Yangtze River Shipping
Wuhan, Hubei
Wanming Wang, 86+18907185598, 1048026357@qq.com
Wanming Wang
- Recruiting
Xingtai City Third Hospital
Xingtai, Hebei
Yingyi Li, 86+13932981963, yingyilixt@163.com
Yingyi Li
About this study
Official title: Drug Eluting Stenting and Aggressive Medical Treatment for Preventing Recurrent Stroke in Intracranial Atherosclerotic Disease Trial: a Prospective, Randomized, Open-labelled, Blinded End-point Trial (DREAM-PRIDE)
The aim of DREAM-PRIDE is to evaluate whether implantation of drug-eluting stent (DES) combined with aggressive medical treatment is more efficacious in prevention of 1-year stroke recurrence than standard medical treatment alone for symptomatic intracranial atherosclerotic disease.
Read the detailed description
This trial is a prospective, multi-center, 1:1 randomized using drug-eluting (Sirolimus) stent combined with aggressive medical treatment versus standard medical treatment to treat symptomatic intracranial atherosclerotic disease. Primary efficacy endpoints (any of the following): 1) any stroke or death within 30 days after enrollment, 2) any stroke or death within 30 days after a revascularization procedure of the qualifying lesion during follow-up, 3) ischemic stroke in the territory of the qualifying artery beyond 30 days to 1 year.
- Conditions
- ICAD - Intracranial Atherosclerotic Disease, ICAS - Intracranial Atherosclerosis, Drug-eluting Stent, Stroke, Drug Eluting Stents (DES), Medical Treatment
- Being tested
- Drug Eluting Stent implantation, Aggressive medical treatment, Risk factor management, Standard medical treatment
- Keywords
- Stroke, Drug-eluting stent, Medical treatment, ICAD-Intracranial Atherosclerotic Disease, ICAS-Intracranial Atherosclerosis, Drug Eluting Stents (DES)
- Medical subject headings
- Intracranial Arteriosclerosis, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug Eluting Stent implantationDevice
Also called Maurora ® Sirolimus Eluting Stent implantation
The Maurora ® Sirolimus Eluting Stent System for intracranial PTA treatment comprises of a balloon expandable sirolimus eluting stent and a delivery catheter that features a rapid exchange catheter design with a semi-compliant balloon located at its distal end.
Aggressive medical treatmentDrug
Also called Dual antiplatelet therapy for 6 months
Aggressive medical treatment consists of dual antiplatelet treatment (aspirin 100 mg per day for the entire follow-up, clopidogrel 75 per day mg, or ticagrelor 90 mg twice per day for 6 months after enrollment).
Risk factor managementBehavioural
Also called Risk factor and life style management
Management of risk factors (hypertension, diabetes, lipoprotein metabolism disorder, smoking and exercise)
Standard medical treatmentDrug
Also called Dual antiplatelet therapy for 3 months
Standard medical treatment consists of dual antiplatelet treatment (aspirin 100 mg per day for the entire follow-up, clopidogrel 75 per day mg, or ticagrelor 90 mg twice per day for 3 months after enrollment).
| Study group | Role | What they receive |
|---|---|---|
| Drug-eluting stent implantation with aggressive medical treatment group | Experimental | DES implantation (The Maurora ® Sirolimus Eluting Stent System) combined with aggressive medical treatment (aspirin 100 mg per day for the entire follow-up, clopidogrel 75 mg per day, or ticagrelor 90 mg twice per day for 6 months); management of risk factors (hypertension, diabetes, lipoprotein metabolism disorder, smoking and exercise) Receives: Device: Drug Eluting Stent implantation; Drug: Aggressive medical treatment; Behavioral: Risk factor management |
| Standard medical treatment group | Active comparator | Standard medical treatment (aspirin 100 mg per day for the entire follow-up, clopidogrel 75 mg per day, or ticagrelor 90 mg twice per day for 3 months after enrolment), management of risk factors (hypertension, diabetes, lipoprotein metabolism disorder, smoking and exercise) Receives: Behavioral: Risk factor management; Drug: Standard medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Any stroke or death within 30 days of enrollment or any revascularization procedure OR an ischemic stroke in the territory of the symptomatic intracranial artery between 31 day to 1 year.
Primary endpoints are composite event of (1) any stroke or death within 30 days after enrollment, (2) any stroke or death within 30 days after revascularization procedure of the qualifying lesion during follow-up, and (3) ischemic stroke in the territory of the qualifying artery from 31 days to 1 year. Ischemic stroke is defined as a new focal neurological deficit of sudden onset, that is associated with infarction lesion on CT or MRI. Ischemic strokes are classified as in or out of the territory of the symptomatic intracranial artery. Symptomatic brain hemorrhage is defined as parenchymal, subarachnoid, or intraventricular hemorrhage detected by CT or MRI that is associated with new neurological signs or symptoms (headache, change in level of consciousness, focal neurological symptoms) lasting ≥ 24 hours or a seizure.
Measured: 12 months after enrollment
Severe or moderate bleeding (GUSTO score)
Bleeding events were defined according to the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) classification for severe or life-threatening, moderate, or mild bleeding:
Severe or life-threatening- Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention
Moderate- Bleeding that requires blood transfusion but does not result in hemodynamic compromise
Mild- Bleeding that does not meet criteria for either severe/life-threatening or moderate bleeding
Measured: 12 months after enrollment
Secondary outcomes (8)
Residual stenosis after the procedure in DES group
Degree of residual stenosis was measured and calculated according to the methods of the Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) trial.
Measured: At the end of the procedure
In-stent restenosis (ISR) rate in DES group within 12 months
The ISR is defined as >50% stenosis within or immediately adjacent (within 5 mm) of the implanted stent and >20% absolute luminal loss.
Measured: 12 months after enrollment
Disabling stroke within 1 year
defined as modified Rankin Scale > 3 at 1 year visit
Measured: 12 months after enrollment
Any stroke, death or myocardial infarction within 1 year
Any stroke included ischemic stroke and symptomatic brain hemorrhage. Symptomatic brain hemorrhage refers to parenchymal, subarachnoid, or intraventricular hemorrhage that was associated with a seizure or with symptoms or signs lasting 24 hours or longer.
Measured: 12 months after enrollment
Major non-stroke hemorrhage within 1 year
A major non-stroke-related hemorrhage was defined as any subdural or epidural hemorrhage or a systemic hemorrhage requiring hospitalization, blood transfusion, or surgery.
Measured: 12 months after enrollment
Modified Rankin Scale score at 1 year
The range of modified Rankin Scale was from 0 to 6. 0-No symptoms;1-No significant disability;2-Slight disability;3-Moderate disability;4-Moderately severe disability;5-Severe disability;6 -Dead.A higher score indicates worse a outcome.
Measured: 12 months after enrollment
Symptomatic intracranial hemorrhage within 1 year
Measured: 12 months after enrollment
Death within 1 year
Death within 1 year
Measured: 12 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start2 Jul 2021
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for ICAD - Intracranial Atherosclerotic DiseaseStudies 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
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 358 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yongjun Wang, MD, Principal investigator, Beijing Tiantan HospitalZhongrong Miao, MD, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04948749
- Sponsor's protocol ID
- HX-A-018(2021)
- Acronym
- DREAM-PRIDE
- Status last verified
- Jul 2026
- First submitted
- 16 Jun 2021
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhou M, Wang H, Zeng X, Yin P, Zhu J, Chen W, Li X, Wang L, Wang L, Liu Y, Liu J, Zhang M, Qi J, Yu S, Afshin A, Gakidou E, Glenn S, Krish VS, Miller-Petrie MK, Mountjoy-Venning WC, Mullany EC, Redford SB, Liu H, Naghavi M, Hay SI, Wang L, Murray CJL, Liang X. Mortality, morbidity, and risk factors in China and its provinces, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2019 Sep 28;394(10204):1145-1158. doi: 10.1016/S0140-6736(19)30427-1. Epub 2019 Jun 24.
PubMed 31248666GBD 2016 Stroke Collaborators. Global, regional, and national burden of stroke, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 May;18(5):439-458. doi: 10.1016/S1474-4422(19)30034-1. Epub 2019 Mar 11.
PubMed 30871944Chimowitz MI, Lynn MJ, Howlett-Smith H, Stern BJ, Hertzberg VS, Frankel MR, Levine SR, Chaturvedi S, Kasner SE, Benesch CG, Sila CA, Jovin TG, Romano JG; Warfarin-Aspirin Symptomatic Intracranial Disease Trial Investigators. Comparison of warfarin and aspirin for symptomatic intracranial arterial stenosis. N Engl J Med. 2005 Mar 31;352(13):1305-16. doi: 10.1056/NEJMoa043033.
PubMed 15800226Chimowitz MI, Lynn MJ, Derdeyn CP, Turan TN, Fiorella D, Lane BF, Janis LS, Lutsep HL, Barnwell SL, Waters MF, Hoh BL, Hourihane JM, Levy EI, Alexandrov AV, Harrigan MR, Chiu D, Klucznik RP, Clark JM, McDougall CG, Johnson MD, Pride GL Jr, Torbey MT, Zaidat OO, Rumboldt Z, Cloft HJ; SAMMPRIS Trial Investigators. Stenting versus aggressive medical therapy for intracranial arterial stenosis. N Engl J Med. 2011 Sep 15;365(11):993-1003. doi: 10.1056/NEJMoa1105335. Epub 2011 Sep 7.
PubMed 21899409Shin YS, Kim BM, Suh SH, Jeon P, Kim DJ, Kim DI, Kim BS, Kim KH, Heo JH, Nam HS, Kim YD. Wingspan stenting for intracranial atherosclerotic stenosis: clinical outcomes and risk factors for in-stent restenosis. Neurosurgery. 2013 Apr;72(4):596-604; discussion 604. doi: 10.1227/NEU.0b013e3182846e09.
PubMed 23277374Jin M, Fu X, Wei Y, Du B, Xu XT, Jiang WJ. Higher risk of recurrent ischemic events in patients with intracranial in-stent restenosis. Stroke. 2013 Nov;44(11):2990-4. doi: 10.1161/STROKEAHA.113.001824. Epub 2013 Aug 20.
PubMed 23963335Lu WD, Huang CW, Li YH, Chen JY. Multiple Mechanisms in 1 In-Stent Restenosis Assessed by Optical Coherence Tomography. JACC Cardiovasc Interv. 2017 Nov 27;10(22):2340-2341. doi: 10.1016/j.jcin.2017.07.017. Epub 2017 Nov 1. No abstract available.
PubMed 29102578
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Eluting Stenting and Aggressive Medical Treatment for Preventing Recurrent Stroke in Intracranial Atherosclerotic Disease Trial: a Prospective, Randomized, Open-labelled, Blinded End-point Trial (DREAM-PRIDE)
- ClinicalTrials.gov ID
- NCT04948749
- Acronym / sponsor ID
- DREAM-PRIDE / HX-A-018(2021)
- Conditions
- ICAD - Intracranial Atherosclerotic Disease, ICAS - Intracranial Atherosclerosis, Drug-eluting Stent, Stroke, Drug Eluting Stents (DES), Medical Treatment
- Keywords
- Stroke, Drug-eluting stent, Medical treatment, ICAD-Intracranial Atherosclerotic Disease, ICAS-Intracranial Atherosclerosis, Drug Eluting Stents (DES)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 358 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 2 Jul 2021 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 2 Jul 2021 (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 aim of DREAM-PRIDE is to evaluate whether implantation of drug-eluting stent (DES) combined with aggressive medical treatment is more efficacious in prevention of 1-year stroke recurrence than standard medical treatment alone for symptomatic intracranial atherosclerotic disease.
Detailed description
This trial is a prospective, multi-center, 1:1 randomized using drug-eluting (Sirolimus) stent combined with aggressive medical treatment versus standard medical treatment to treat symptomatic intracranial atherosclerotic disease. Primary efficacy endpoints (any of the following): 1) any stroke or death within 30 days after enrollment, 2) any stroke or death within 30 days after a revascularization procedure of the qualifying lesion during follow-up, 3) ischemic stroke in the territory of the qualifying artery beyond 30 days to 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Drug-eluting stent implantation with aggressive medical treatment group | Experimental | Device: Drug Eluting Stent implantation, Drug: Aggressive medical treatment, Behavioral: Risk factor managementDES implantation (The Maurora ® Sirolimus Eluting Stent System) combined with aggressive medical treatment (aspirin 100 mg per day for the entire follow-up, clopidogrel 75 mg per day, or ticagrelor 90 mg twice per day for 6 months); management of risk factors (hypertension, diabetes, lipoprotein metabolism disorder, smoking and exercise) |
| Standard medical treatment group | Active comparator | Behavioral: Risk factor management, Drug: Standard medical treatmentStandard medical treatment (aspirin 100 mg per day for the entire follow-up, clopidogrel 75 mg per day, or ticagrelor 90 mg twice per day for 3 months after enrolment), management of risk factors (hypertension, diabetes, lipoprotein metabolism disorder, smoking and exercise) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age from 18 to 85 years
- Patients with ischemic stroke within 30 days of enrolment attributed to 70% to 99% stenosis of a major intracranial artery (internal carotid artery [C5-C7], middle cerebral artery [M1], vertebral artery [V4], or basilar artery) on CTA (According to WASID method)
- The diameter of the target vessel between 2.0mm - 4.5mm
- The stenosis lesion length ≤ 14 mm
- Baseline modified Rankin Scale (mRS) score ≤ 3
Key exclusion criteria (23 listed)
- Ischemic stroke occurred within 7 days before enrolment
- Tandem extracranial or intracranial stenosis (70%-99%) or occlusion that is proximal or distal to the target intracranial lesion (NOTE: an exception is allowed if stenosis or occlusion involves a single vertebral artery proximal to a symptomatic basilar artery stenosis and the contralateral vertebral artery is supplying the basilar artery)
- Bilateral intracranial vertebral artery stenosis of 70%-99% and uncertainty about which artery is symptomatic (NOTE: an exception is that if bilateral vertebral arteries with 70%-99% stenosis but unequal in size, the dominant side is considered as symptomatic)
- Unilateral vertebral artery stenosis of 70%-99% with normal contralateral vertebral artery
- Stroke caused by perforating artery occlusion
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 Eluting Stent implantationAlso: Maurora ® Sirolimus Eluting Stent implantationThe Maurora ® Sirolimus Eluting Stent System for intracranial PTA treatment comprises of a balloon expandable sirolimus eluting stent and a delivery catheter that features a rapid exchange catheter design with a semi-compliant balloon located at its distal end. | Device | Drug-eluting stent implantation with aggressive medical treatment group |
| Aggressive medical treatmentAlso: Dual antiplatelet therapy for 6 monthsAggressive medical treatment consists of dual antiplatelet treatment (aspirin 100 mg per day for the entire follow-up, clopidogrel 75 per day mg, or ticagrelor 90 mg twice per day for 6 months after enrollment). | Drug | Drug-eluting stent implantation with aggressive medical treatment group |
| Risk factor managementAlso: Risk factor and life style managementManagement of risk factors (hypertension, diabetes, lipoprotein metabolism disorder, smoking and exercise) | Behavioural | Drug-eluting stent implantation with aggressive medical treatment group, Standard medical treatment group |
| Standard medical treatmentAlso: Dual antiplatelet therapy for 3 monthsStandard medical treatment consists of dual antiplatelet treatment (aspirin 100 mg per day for the entire follow-up, clopidogrel 75 per day mg, or ticagrelor 90 mg twice per day for 3 months after enrollment). | Drug | Standard medical treatment group |
Primary outcome
Any stroke or death within 30 days of enrollment or any revascularization procedure OR an ischemic stroke in the territory of the symptomatic intracranial artery between 31 day to 1 year.
Time frame: 12 months after enrollment
Primary endpoints are composite event of (1) any stroke or death within 30 days after enrollment, (2) any stroke or death within 30 days after revascularization procedure of the qualifying lesion during follow-up, and (3) ischemic stroke in the territory of the qualifying artery from 31 days to 1 year. Ischemic stroke is defined as a new focal neurological deficit of sudden onset, that is associated with infarction lesion on CT or MRI. Ischemic strokes are classified as in or out of the territory of the symptomatic intracranial artery. Symptomatic brain hemorrhage is defined as parenchymal, subarachnoid, or intraventricular hemorrhage detected by CT or MRI that is associated with new neurological signs or symptoms (headache, change in level of consciousness, focal neurological symptoms) lasting ≥ 24 hours or a seizure.
Severe or moderate bleeding (GUSTO score)
Time frame: 12 months after enrollment
Bleeding events were defined according to the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) classification for severe or life-threatening, moderate, or mild bleeding: Severe or life-threatening- Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention Moderate- Bleeding that requires blood transfusion but does not result in hemodynamic compromise Mild- Bleeding that does not meet criteria for either severe/life-threatening or moderate bleeding
8 secondary outcomes
Residual stenosis after the procedure in DES group
Time frame: At the end of the procedure
In-stent restenosis (ISR) rate in DES group within 12 months
Time frame: 12 months after enrollment
Disabling stroke within 1 year
Time frame: 12 months after enrollment
Any stroke, death or myocardial infarction within 1 year
Time frame: 12 months after enrollment
Major non-stroke hemorrhage within 1 year
Time frame: 12 months after enrollment
Modified Rankin Scale score at 1 year
Time frame: 12 months after enrollment
Symptomatic intracranial hemorrhage within 1 year
Time frame: 12 months after enrollment
Death within 1 year
Time frame: 12 months 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 15 Jul 2026.
- Background: PubMed 31248666Zhou M, Wang H, Zeng X, Yin P, Zhu J, Chen W, Li X, Wang L, Wang L, Liu Y, Liu J, Zhang M, Qi J, Yu S, Afshin A, Gakidou E, Glenn S, Krish VS, Miller-Petrie MK, Mountjoy-Venning WC, Mullany EC, Redford SB, Liu H, Naghavi M, Hay SI, Wang L, Murray CJL, Liang X. Mortality, morbidity, and risk factors in China and its provinces, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2019 Sep 28;394(10204):1145-1158. doi: 10.1016/S0140-6736(19)30427-1. Epub 2019 Jun 24.
- Background: PubMed 30871944GBD 2016 Stroke Collaborators. Global, regional, and national burden of stroke, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 May;18(5):439-458. doi: 10.1016/S1474-4422(19)30034-1. Epub 2019 Mar 11.
- Background: PubMed 15800226Chimowitz MI, Lynn MJ, Howlett-Smith H, Stern BJ, Hertzberg VS, Frankel MR, Levine SR, Chaturvedi S, Kasner SE, Benesch CG, Sila CA, Jovin TG, Romano JG; Warfarin-Aspirin Symptomatic Intracranial Disease Trial Investigators. Comparison of warfarin and aspirin for symptomatic intracranial arterial stenosis. N Engl J Med. 2005 Mar 31;352(13):1305-16. doi: 10.1056/NEJMoa043033.
- Background: PubMed 21899409Chimowitz MI, Lynn MJ, Derdeyn CP, Turan TN, Fiorella D, Lane BF, Janis LS, Lutsep HL, Barnwell SL, Waters MF, Hoh BL, Hourihane JM, Levy EI, Alexandrov AV, Harrigan MR, Chiu D, Klucznik RP, Clark JM, McDougall CG, Johnson MD, Pride GL Jr, Torbey MT, Zaidat OO, Rumboldt Z, Cloft HJ; SAMMPRIS Trial Investigators. Stenting versus aggressive medical therapy for intracranial arterial stenosis. N Engl J Med. 2011 Sep 15;365(11):993-1003. doi: 10.1056/NEJMoa1105335. Epub 2011 Sep 7.
- Background: PubMed 23277374Shin YS, Kim BM, Suh SH, Jeon P, Kim DJ, Kim DI, Kim BS, Kim KH, Heo JH, Nam HS, Kim YD. Wingspan stenting for intracranial atherosclerotic stenosis: clinical outcomes and risk factors for in-stent restenosis. Neurosurgery. 2013 Apr;72(4):596-604; discussion 604. doi: 10.1227/NEU.0b013e3182846e09.
- Background: PubMed 23963335Jin M, Fu X, Wei Y, Du B, Xu XT, Jiang WJ. Higher risk of recurrent ischemic events in patients with intracranial in-stent restenosis. Stroke. 2013 Nov;44(11):2990-4. doi: 10.1161/STROKEAHA.113.001824. Epub 2013 Aug 20.
- Background: PubMed 29102578Lu WD, Huang CW, Li YH, Chen JY. Multiple Mechanisms in 1 In-Stent Restenosis Assessed by Optical Coherence Tomography. JACC Cardiovasc Interv. 2017 Nov 27;10(22):2340-2341. doi: 10.1016/j.jcin.2017.07.017. Epub 2017 Nov 1. No abstract available.
- 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.
Yongjun Wang, MD principal investigator
Beijing Tiantan Hospital
Zhongrong Miao, MD principal investigator
Beijing Tiantan Hospital
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drug Eluting Stent implantation, Aggressive medical treatment and Risk factor management in people with ICAD - Intracranial Atherosclerotic Disease and ICAS - Intracranial Atherosclerosis, run by Beijing Tiantan Hospital at 18 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 6 inclusion and 23 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 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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 Ning Ma, MD (13581889908, maning_03@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Any stroke or death within 30 days of enrollment or any revascularization procedure OR an ischemic stroke in the territory of the symptomatic intracranial artery between 31 day to 1 year. (time frame: 12 months after enrollment). The study lists 2 primary outcomes in all. 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 NCT04948749, which also lists 7 linked publications.
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 15 Jul 2026.