This is a prospective, multi-center, open-access, single-arm trial to observe the real-world clinical efficacy of drug-eluting vertebral artery stenting system treatment for Atherosclerotic Vertebral Arteries Stenosis. Patients will be followed at 30 days, 6, and 12 months post-procedure and annually for 1 year within 3 years.
Stroke has been one of the most important causes of disability and death worldwide today. Ischemic stroke accounts for more than 50% of these strokes. The results of epidemiological surveys show that in 2018, more than 3 million new strokes occurred each year in China. In 2018, more than 3 million people suffered from a stroke, and more than 2 million people died from a stroke. Studies show that about 25% to 40% of transient ischemic attacks (TIA) or strokes occur in the posterior circulation. The subclavian and vertebral arteries are important blood vessels in the posterior circulation and are important original sites for ischemic strokes in the posterior circulation. About 20% of strokes in the posterior circulation are caused by extracranial vertebral artery stenosis (ECVAS). Endovascular intervention is the recommended treatment for ECVAS. It is effective in promoting the perfusion of brain tissue in the area of the responsible artery, thereby reducing the risk of stroke recurrence, improving neurological prognosis, and reducing symptoms. The drug-eluting stent is effective in reducing the incidence of postoperative restenosis (ISR), thus further reducing the long-term risk of stroke. Vertebral artery drug-eluting stents Maurora® was approved for marketing in 2020 and has been shown to be effective in reducing restenosis in clinical trials. The purpose of this study is to further investigate its long-term effectiveness in treating vertebral artery stenosis in the real world.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
144
Vertebral artery drug-eluting stents Maurora® was approved for marketing in 2020 and has been shown to be effective in reducing restenosis in clinical trials.
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
RECRUITINGIncidence of clinical ischemic events
Examples of clinical cerebral ischemic events: TIA or ischemic stroke event in the blood supply area of the target lesion
Time frame: within 1 year
Clinical Success Rate
Successful arrival and release of the stent in the target lesion with complete coverage of the lesion and residual stenosis \<30%, no major adverse events (MAE).
Time frame: within 1 year after surgery
Major adverse event (MAE) incidence
Major adverse events (MAE) include all-cause death, any type of stroke (ischemic/hemorrhagic stroke) within 30 days of surgery, TIA or ischemic stroke in the target lesion supply area within 1 year, clinically driven target lesion revascularization (CD-TVL), thrombotic event.
Time frame: 1 month, 6 months, 12 months, 2 and 3 years
Incidence of bleeding events
Access or non access site bleeding
Time frame: 30 days and 1 year
Incidence of in-stent restenosis
Restenosis: in-stent stenosis rate ≥50% on imaging
Time frame: within 1 year
Changes in the modified Rankin scale (mRS) scores
ability to perform daily living,mRS scores ranges 0-6 , the more score the more severe outcome
Time frame: 1 month, 6 months, 12 months, 2 and 3 years
Change in NIHSS scores
NIHSS scores for neurological deficits
Time frame: 1 month, 6 months, 12 months, 2 and 3 years
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Correlation of risk factors with the occurrence of major adverse events
Major adverse events (MAE) include all-cause death, any type of stroke (ischemic/hemorrhagic stroke) within 30 days of surgery, TIA or ischemic stroke in the target lesion supply area within 1 year, clinically driven target lesion revascularization (CD-TVL), thrombotic event.
Time frame: 1 month, 6 months, 12 months, 2 and 3 years
Correlation of risk factors with the occurrence of restenosis
Thrombosis in study stents
Time frame: 1 month, 6 months, 12 months, 2 and 3 years
Evaluation of clinical use for relative contraindications
Evaluation of clinical cerebral ischemic events: TIA or ischemic stroke event in the blood supply area of the target lesion for contraindications patients
Time frame: 1 month, 6 months, 12 months, 2 and 3 years