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)
Overview
- Phase
- Not Applicable
- Intervention
- Drug Eluting Stent implantation
- Conditions
- ICAD - Intracranial Atherosclerotic Disease
- Sponsor
- Beijing Tiantan Hospital
- Enrollment
- 792
- Locations
- 18
- Primary Endpoint
- 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.
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief 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.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 \[C4-C7\], 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
Exclusion Criteria
- •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
- •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
Arms & Interventions
Drug-eluting stent implantation with aggressive medical treatment group
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)
Intervention: Drug Eluting Stent implantation
Drug-eluting stent implantation with aggressive medical treatment group
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)
Intervention: Aggressive medical treatment
Drug-eluting stent implantation with aggressive medical treatment group
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)
Intervention: Risk factor management
Standard medical treatment group
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)
Intervention: Risk factor management
Standard medical treatment group
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)
Intervention: Standard medical treatment
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Disabling stroke within 1 year(12 months after enrollment)
- Residual stenosis after the procedure in DES group(At the end of the procedure)
- In-stent restenosis (ISR) rate in DES group within 12 months(12 months after enrollment)
- Any stroke, death or myocardial infarction within 1 year(12 months after enrollment)
- Major non-stroke hemorrhage within 1 year(12 months after enrollment)
- Modified Rankin Scale score at 1 year(12 months after enrollment)
- Death within 1 year(12 months after enrollment)