Efficacy of Drug-Eluting Vertebral Artery Stenting Treatment for Atherosclerotic Vertebral Arteries Stenosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy of Drug-Eluting Vertebral Artery Stenting Treatment for Atherosclerotic Vertebral Arteries Stenosis in Real-World Clinical Observations: a Prospective, Multicenter, Open-access, Single-arm Clinical Study

Conditions
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Ischemic Stroke, Vertebral Artery Stenosis

Intervention / Treatment
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* Device: The drug-eluting stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years old, gender is not limited; Patients with medically prescribed rapamycin drug-eluting vertebral artery stent systems; Patients and family members fully understand the trial's purpose, voluntarily participate in the trial and sign the informed consent form. Exclusion Criteria: Unable to receive dual antiplatelet therapy due to known disease, or severe coagulation abnormalities, severe infections that are not controlled, severe systemic disease, uncontrollable hypertension, and contraindicated for surgery; With an aneurysm that cannot be treated earlier or simultaneously or is not suitable for surgery; Gastrointestinal disease with active bleeding; Previous myocardial infarction or large-scale cerebral infarction within 2 weeks; Known contraindications to heparin, rapamycin, anesthesia, and contrast agents; Life expectancy less than 12 months; the investigator judged patients to be unsuitable for participation in this study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with vertebral atherosclerotic stenosis requiring stent implantation<br>Referring to the 2015 Chinese Guidelines for Endovascular Interventional Treatment of Ischemic Cerebrovascular Disease, the 2015 Symptomatic Atherosclerotic Sclerotic vertebral artery initiation stenosis: Chinese expert consensus and Subclavian/extracranial vertebral artery stenosis: Chinese expert consensus in 2019 and other guidelines and expert consensus for the diagnosis of symptomatic vertebral artery atherosclerotic stenosis ≥ 50% and non-symptomatic vertebral artery atherosclerotic stenosis ≥ 70% in patients. | Device: The drug-eluting stent<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of clinical ischemic events | Examples of clinical cerebral ischemic events: TIA or ischemic stroke event in the blood supply area of the target lesion | within 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | 1 month, 6 months, 12 months, 2 and 3 years | 
| Incidence of bleeding events | Access or non access site bleeding | 30 days and 1 year | 
| Incidence of in-stent restenosis | Restenosis: in-stent stenosis rate ≥50% on imaging | 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 | 1 month, 6 months, 12 months, 2 and 3 years | 
| Change in NIHSS scores | NIHSS scores for neurological deficits | 1 month, 6 months, 12 months, 2 and 3 years | 
| 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. | 1 month, 6 months, 12 months, 2 and 3 years | 
| Correlation of risk factors with the occurrence of restenosis | Thrombosis in study stents | 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 | 1 month, 6 months, 12 months, 2 and 3 years |