The trial is a prospective, multicenter, open-label, superiority, randomized controlled clinical trial. The experimental groups include two types of drug-eluting stents:
* Experimental Device A, a self-expanding rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China) * Experimental Device B, a balloon-expandable rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China) The device used in the control group is the Apollo® Intracranial Artery Stent System, a balloon-expandable bare-metal stent (MicroPort NeuroTech, Shanghai, China), According to the inclusion and exclusion criteria specified in the protocol, approximately 249 subjects with symptomatic cerebral artery atherosclerotic stenosis will be enrolled in China and randomized to Experimental Group A, Experimental Group B, or the control group.
Considering the broader applicability of Experimental Device A and Experimental Device B compared to the control device, a specification subgroup is established. 20 subjects with lesions only suitable for the unique specifications of Experimental Device A or Experimental Device B will be enrolled in China. These subjects will not undergo randomization, and their data will be analyzed separately without hypothesis testing.
Moreover, a subgroup of Experimental Device B is established at a study center in Brazil. 10 subjects meeting the trial's inclusion and criteria will be enrolled. These subjects will not undergo randomization, and their data will be analyzed separately without hypothesis testing, only to support overseas registration.
Overall, the total sample size for the study is 279 subjects. Clinical assessment will be conducted for all subjects before the procedure, during the procedure, at discharge, at 1 month (±7 days) follow-up, at 6 months (±30 days) follow-up, and at 12 months (±60 days) follow-up. At 12 months (±60 days), patients will undergo follow-up with DSA imaging. Unscheduled follow-ups may be performed as needed to record relevant indicators and evaluate the safety and efficacy of the two drug-eluting stents in the treatment of symptomatic cerebral artery atherosclerotic stenosis.
1) Age 18-80 years old
2) Symptomatic cerebral artery atherosclerotic stenosis (defined as ischemic stroke or TIA due to qualifying lesion stenosis occurring in the past 6 months) with ineffective antiplatelet therapy or hypoperfusion in the territory of qualifying artery or with poor collateral circulation
3) Lesion located in a major cerebral artery, including the internal carotid artery, middle cerebral artery, vertebral artery, or basilar artery
4) 70%-99% stenosis of qualifying lesion according to WASID method diagnosed by DSA
1) mRS score≥3
2) Last ischemic stroke onset within 2 weeks
3) Presence of 2 or more atherosclerotic stenotic lesions in the cerebral arteries requiring interventional or surgical treatment.
4) Only perforator infarctions in the territory of qualifying artery according to preoperative imaging
Parallel
Experimental Device A, a self-expanding rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China)
DeviceExperimental Device A, a self-expanding rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China)
Experimental Device B, a balloon-expandable rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China)
DeviceExperimental Device B, a balloon-expandable rapamycin target-eluting stent (MicroPort NeuroTech, Shanghai, China)
Apollo® Intracranial Artery Stent System, a balloon-expandable bare-metal stent (MicroPort NeuroTech, Shanghai, China),
DeviceApollo® Intracranial Artery Stent System, a balloon-expandable bare-metal stent (MicroPort NeuroTech, Shanghai, China)
In-stent restenosis (ISR) rate at 12 months post-procedure
ISR is defined as \>50% stenosis within or adjacent (within 5 mm) to the stent as well as \>20% absolute luminal loss according to the WASID method diagnosed by DSA
Technical success rate of stent implantation
defined as successful implantation into qualifying lesion as well as successful retraction of delivery system
Symptomatic ISR rate at 12 months post-procedure
ISR (ISR is defined as \>50% stenosis within or adjacent (within 5 mm) to the stent as well as \>20% absolute luminal loss according to the WASID method diagnosed by DSA) occurs with ischemic stroke or TIA from target lesion restenosis. Stroke is defined as acute focal/systemic neurological dysfunction from brain/spinal cord/retinal vascular occlusion, stenosis, or injury - induced hemorrhage/infarction. TIA is defined as transient focal neurological dysfunction from brain/spinal cord/retinal ischemia, with symptoms lasting\<24 hours and no acute infarction.
Revascularization rate from qualifying artery at 12 months post-procedure
During follow-up, revascularization procedures (including interventional thrombectomy, angioplasty, vascular bypass, etc.) due to ischemic stroke or TIA from target lesions. Stroke is defined as acute focal/systemic neurological dysfunction from brain/spinal cord/retinal vascular occlusion, stenosis, or injury - induced hemorrhage/infarction. TIA is defined as transient focal neurological dysfunction from brain/spinal cord/retinal ischemia, with symptoms lasting\<24 hours and no acute infarction.
Modified Rankin Scale (mRS) score at 12 months post-procedure
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