An interventional study of Drug Eluting Stent implantation and Aggressive medical treatment in ICAD - Intracranial Atherosclerotic Disease, ICAS - Intracranial Atherosclerosis and Drug-eluting Stent, sponsored by Beijing Tiantan Hospital. Recruiting at 18 sites in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-07-15.
Sponsored by Beijing Tiantan Hospital · Not applicable, Interventional, and Treatment
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.
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.
93 studies on the registry are indexed under Intracranial Arteriosclerosis; 41 are open to participants now.
This study's planned enrollment of 358 is above the median of 194 across 55 interventional studies indexed under Intracranial Arteriosclerosis.
Browse Intracranial Arteriosclerosis studies →Beijing Tiantan Hospital is the lead sponsor of 465 studies on the registry; 282 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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)
Device: Drug Eluting Stent implantation · Drug: Aggressive medical treatment · Behavioral: Risk factor management
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)
Behavioral: Risk factor management · Drug: Standard medical treatment
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.
Also known as: Maurora ® Sirolimus Eluting Stent implantation
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).
Also known as: Dual antiplatelet therapy for 6 months
Management of risk factors (hypertension, diabetes, lipoprotein metabolism disorder, smoking and exercise)
Also known as: Risk factor and life style management
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).
Also known as: Dual antiplatelet therapy for 3 months
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.
Time frame: 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
Time frame: 12 months after enrollment
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.
Time frame: 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.
Time frame: 12 months after enrollment
Disabling stroke within 1 year
defined as modified Rankin Scale \> 3 at 1 year visit
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months after enrollment
Symptomatic intracranial hemorrhage within 1 year
Time frame: 12 months after enrollment
Death within 1 year
Death within 1 year
Time frame: 12 months after enrollment
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Intracranial Arteriosclerosis→
Beijing Tiantan Hospital