A Prospective, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Safety and Efficacy of a Cerebral Embolic Protection Device for Capturing and Removing Thrombus/Tissue Debris During Transcatheter Aortic Valve Replacement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 260
- 试验地点
- 1
研究概览
简要总结
To evaluate the safety and effectiveness of the Cerebral Protection System (model CEP016F, Shanghai Shenqi Medical Technology Co., Ltd.) for capturing and removing thrombotic and tissue debris during transcatheter aortic valve replacement (TAVR).
详细描述
This study is a prospective, multicenter, randomized controlled clinical trial designed to evaluate the safety and effectiveness of the Cerebral Protection System (model CEP016F, Shanghai Shenqi Medical Technology Co., Ltd.) for capturing and removing thrombotic and tissue debris during transcatheter aortic valve replacement (TAVR). The target study population includes adult patients who are suitable for TAVR using commercially available domestic transcatheter aortic valve systems and whose vascular anatomy is appropriate for placement of the device in the brachiocephalic artery and left common carotid artery. The planned sample size is 260 subjects. Eligible subjects will be randomized in a 1:1 ratio to the device group (TAVR with the cerebral protection system) or the control group (TAVR without the device) using a centralized stratified randomization system based on valve type (self-expanding or balloon-expandable). All subjects are planned to undergo follow-up within 24 hours after procedure, at 2±1 days, at 48-72 hours or before discharge (whichever comes first), and at 30 days after TAVR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years, male or non-pregnant/non-lactating female.
- •Suitable for TAVR and planned to undergo TAVR using an approved transcatheter aortic valve system.
- •TAVR access limited to transfemoral or transapical approach.
- •Imaging-confirmed left common carotid artery diameter of 6.5-10 mm and brachiocephalic artery diameter of 9-15 mm at the site of filter placement.
- •No severe stenosis (>70%), dilation, dissection, ostial aneurysm, or aneurysm within 3 cm of the aortic origin in the target vessels.
- •Brain imaging evaluable by 3-Tesla magnetic resonance imaging.
- •Willing to comply with protocol-required follow-up assessments.
- •Written informed consent provided by the subject or legal guardian.
排除标准
- •Impaired right upper limb blood flow.
- •Intracranial hemorrhage, stroke, or transient ischemic attack within 6 months before procedure.
- •Acute myocardial infarction within 1 month before procedure.
- •Calcification in the intended filter deployment region.
- •Planned pacemaker or defibrillator implantation within 30 days after TAVR.
- •Left ventricular ejection fraction ≤20%.
- •Infective endocarditis, intracardiac/aortic mass, thrombus, or vegetation on echocardiography.
- •Severe occlusive carotid disease requiring concomitant carotid intervention, or carotid stenting/endarterectomy within 6 weeks.
- •Leukopenia, acute anemia, thrombocytopenia, bleeding diathesis, or coagulation disorder.
- •Active peptic ulcer disease or gastrointestinal bleeding within 3 months.
- •Severe allergy or known contraindication to nitinol, stainless steel alloy, or contrast media.
- •Contraindication to antiplatelet and/or anticoagulation therapy, or refusal of blood transfusion.
- •Severe renal insufficiency (serum creatinine >3.0 mg/dL, eGFR <30 mL/min, or need for renal replacement therapy).
- •Known psychiatric disease or substance abuse that may interfere with compliance or data interpretation.
- •Life expectancy <1 year.
- •Active infection requiring concurrent antibiotic therapy.
- •Other clinical conditions preventing compliance with the instructions for use of the investigational device.
- •Concurrent use or planned use of another investigational device or drug during the study period.
- •Severe tortuosity of right upper extremity vessels or inability to accommodate a 6 F sheath.
- •Contraindication to MRI, including implanted pacemaker/defibrillator, metal implants, metal fragments, clips, or intracranial/ocular implanted devices.