Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515, China
Location status: Recruiting
Location contact
Kaibing Huang
CONTACT
Zhong Ji, PHD
CONTACT
NCT Number: NCT05644314
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Guangzhou, Guangdong, 510515, China
Location status: Recruiting
Kaibing Huang
CONTACT
Zhong Ji, PHD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: within 1 year
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 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).
Time frame: 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.
Time frame: 30 days and 1 year
Access or non access site bleeding
Time frame: within 1 year
Restenosis: in-stent stenosis rate ≥50% on imaging
Time frame: 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
Time frame: 1 month, 6 months, 12 months, 2 and 3 years
NIHSS scores for neurological deficits
Time frame: 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.
Time frame: 1 month, 6 months, 12 months, 2 and 3 years
Thrombosis in study stents
Time frame: 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
Contact information is provided by the study sponsor or research team.
Nanfang Hospital, Southern Medical University
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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