DR.BEYOND-2 is an investigator-initiated, prospective, multicenter, randomized, open-label, blinded-endpoint, parallel-group clinical trial designed to evaluate the efficacy and safety of drug-coated balloon (DCB) angioplasty plus aggressive medical management compared with aggressive medical management alone in patients with high-risk symptomatic intracranial atherosclerotic stenosis (sICAS).
A total of 570 eligible patients will be randomized in a 1:1 ratio to the DCB group or the medical management group. Patients assigned to the DCB group will undergo DCB angioplasty in addition to aggressive medical management, with rescue stenting permitted when clinically necessary according to the study protocol. Patients assigned to the control group will receive aggressive medical management alone.
The primary endpoint is the composite of any stroke or death within 30 days after enrollment and ischemic stroke in the territory of the qualifying artery from day 31 through 1 year. Participants will be followed for up to 3 years to further evaluate recurrent ischemic events, vascular outcomes, functional outcomes, and long-term safety.
Age 18-80 years old, regardless of gender
Patients with symptomatic ICAS caused by stenosis of a major intracranial artery (the degree of ischemic stroke with target vessel stenosis within 90 days before enrollment is required to be 70-99%, or the degree of transient ischemic attack with target vessel stenosis is required to be 80-99%), standardized drug management of at least one antithrombotic drug and/or vascular risk factors
DSA or CTA confirmed that the stenosis degree of one main intracranial artery (internal carotid artery C4-C7 segment, middle cerebral artery M1 segment, vertebral artery V4 segment and basilar artery) was between 70% and 99% (measured by WASID method), and was corresponding to the clinical symptoms. The normal diameter of the proximal end of the target lesion was ≥ 2mm, and the length of the target lesion was ≤ 15mm
If the target lesion is located in the anterior circulation system (C4-C7 of the internal carotid artery or M1 of the middle cerebral artery), it is required that there is hypoperfusion in the blood supply area of the target vessel (at least one of the following conditions is met): ①head CTP or PWI showed that CBF in the target vessel area decreased significantly (the lesion side decreased by more than 30% compared with the opposite side); ②Cerebral infarction with hemodynamic abnormalities confirmed by head CT or MRI (such as watershed infarction); ③ASITN/SIR collateral circulation score based on DSA<3 points)
Serious calcification of target vessels, or serious distortion of target vessels or anatomical factors make it difficult for interventional instruments to be in place
Severe stenosis or occlusion of extracranial or intracranial vessels in series at the proximal or distal end of the target vessel
Major surgical operations have been performed in recent 3 weeks
Cerebral hemorrhage, massive cerebral infarction (the infarct area is greater than 50% of the middle cerebral artery supply area; cerebellar infarction: the infarct diameter is greater than 3cm) and myocardial infarction have occurred in the past three months
Parallel
Drug-Coated Balloon Angioplasty
Procedure/SurgeryParticipants randomized to the experimental group will undergo intracranial drug-coated balloon angioplasty using a submaximal angioplasty strategy. Predilation with an uncoated balloon is performed before drug-coated balloon angioplasty. Rescue stenting is permitted when severe dissection, residual stenosis \>50%, marked elastic recoil, or other protocol-defined conditions occur.
Aggressive Medical Management
Other interventionAggressive medical management will be provided to participants in both groups and includes antiplatelet therapy, intensive lipid-lowering treatment, blood pressure and glucose control, and management of other vascular risk factors. Aspirin 100 mg/day is administered throughout follow-up, with clopidogrel 75 mg/day during the first 90 days after enrollment. Alternative antiplatelet therapy may be used according to platelet function or CYP2C19 genotype when appropriate.
Percentage of Participants With Any stroke or death within 30 days after enrollment and recurrence of ischemic stroke in the target vessel area within 30 days to 1 year after enrollment
Percentage of Participants With Any stroke or death within 30 days after enrollment and recurrence of ischemic stroke in the target vessel area within 30 days to 1 year after enrollment.
Percentage of Participants With Any stroke or death within 30 days after enrollment
Percentage of Participants With Any stroke or death within 30 days after enrollment.
Percentage of Participants With Recurrent Ischemic Stroke in any region within 30 days to 1 year after enrollment
Recurrence of ischemic stroke in any region within 30 days to 1 year after enrollment.
Percentage of Participants With Recurrent TIA in the Territory of the Qualifying Artery Within 1 Year After Enrollment
TIA recurrence in target vessel area within 1 year after enrollment.
Percentage of Participants With Recurrent TIA in Any Vascular Territory Within 1 Year After Enrollment
TIA recurrence in any region within 1 year after enrollment.
Changes in Target-Vessel Imaging Characteristics Assessed by High-Resolution MRI at 1 Year (±1 Month) After Enrollment
High-resolution MRI will be used to characterize interval changes in the vessel wall and atherosclerotic plaque of the qualifying artery, including plaque enhancement and other morphological characteristics, as applicable.
Percentage of Participants With Recurrent Ischemic Stroke in Any Vascular Territory Within 3 Years After Enrollment
Recurrence of ischemic stroke in any region within 3 years after enrollment.
Percentage of Participants With Recurrent Ischemic Stroke in the Territory of the Qualifying Artery Within 3 Years After Enrollment
Recurrence of ischemic stroke in target vessel area within 3 years after enrollment.
Percentage of Participants With Recurrent TIA in the Territory of the Qualifying Artery Within 3 Years After Enrollment
TIA recurrence in target vessel area within 3 years after enrollment.
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Beijing Tiantan Hospital
Lead sponsor
Baotou Central Hospital
Collaborator
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