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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
792
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 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).
Management of risk factors (hypertension, diabetes, lipoprotein metabolism disorder, smoking and exercise)
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).
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China
RECRUITINGBeijing Daxing District People's Hospital
Beijing, Beijing Municipality, China
RECRUITINGHejian People's Hospital
Cangzhou, Hebei, China
RECRUITINGNorth China University of Science and Technology Affiliated Hospital
Tangshan, Hebei, China
RECRUITINGXingtai City Third Hospital
Xingtai, Hebei, China
RECRUITINGGeneral Hospital of The Yangtze River Shipping
Wuhan, Hubei, China
RECRUITINGBaotou Central Hospital
Baotou, Inner Mongolia, China
RECRUITINGInner Mongolia Autonomous Region People's Hospital
Hohhot, Inner Mongolia, China
RECRUITINGTongliao City Hospital
Tongliao, Inner Mongolia, China
RECRUITINGWuhai People's Hospital
Wuhai, Inner Mongolia, China
RECRUITING...and 8 more locations
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
Death within 1 year
Death within 1 year
Time frame: 12 months after enrollment
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