Ischemic Stroke, Vertebral Artery Stenosis
Conditions
Brief summary
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
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.
Interventions
DEVICEThe drug-eluting stent
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.
Sponsors
Nanfang Hospital, Southern Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years old, gender is not limited; 2. Patients with medically prescribed rapamycin drug-eluting vertebral artery stent systems; 3. Patients and family members fully understand the trial's purpose, voluntarily participate in the trial and sign the informed consent form.
Exclusion criteria
1. 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; 2. With an aneurysm that cannot be treated earlier or simultaneously or is not suitable for surgery; 3. Gastrointestinal disease with active bleeding; 4. Previous myocardial infarction or large-scale cerebral infarction within 2 weeks; 5. Known contraindications to heparin, rapamycin, anesthesia, and contrast agents; 6. Life expectancy less than 12 months; 7. the investigator judged patients to be unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of clinical ischemic events | within 1 year | Examples of clinical cerebral ischemic events: TIA or ischemic stroke event in the blood supply area of the target lesion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse event (MAE) incidence | 1 month, 6 months, 12 months, 2 and 3 years | 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. |
| Incidence of bleeding events | 30 days and 1 year | Access or non access site bleeding |
| Incidence of in-stent restenosis | within 1 year | Restenosis: in-stent stenosis rate ≥50% on imaging |
| Changes in the modified Rankin scale (mRS) scores | 1 month, 6 months, 12 months, 2 and 3 years | ability to perform daily living，mRS scores ranges 0-6 ， the more score the more severe outcome |
| Clinical Success Rate | within 1 year after surgery | 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). |
| Correlation of risk factors with the occurrence of major adverse events | 1 month, 6 months, 12 months, 2 and 3 years | 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. |
| Correlation of risk factors with the occurrence of restenosis | 1 month, 6 months, 12 months, 2 and 3 years | Thrombosis in study stents |
| Evaluation of clinical use for relative contraindications | 1 month, 6 months, 12 months, 2 and 3 years | Evaluation of clinical cerebral ischemic events: TIA or ischemic stroke event in the blood supply area of the target lesion for contraindications patients |
| Change in NIHSS scores | 1 month, 6 months, 12 months, 2 and 3 years | NIHSS scores for neurological deficits |
Countries
China
Contacts
Primary ContactZhong Ji, PHD
Backup ContactKaibin Huang
Outcome results
None listed