CTRI/2024/10/075223招募中4 期
A Post-Market Study of the Use of ACURATE neo2TM Transfemoral Valve System with or without SENTINELâ„¢ Cerebral Protection System in Treating Patients with Symptomatic Severe Aortic Stenosis. ACURATE neo2 and SENTINEL Post Market study
Boston Scientific India10 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年10月28日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 10
- 主要终点
- All cause mortality through 30 days post index procedure
研究概览
简要总结
NA
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 65.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subject should be greater than 65 years of age.
- •2.Subject (or legal guardian) understands the study requirements and procedure, and provides written informed consent, and is willing to comply with all protocol-required follow-up evaluations.
- •3.Subject is clinically indicated for TAVR to treat symptomatic severe aortic stenosis with the ACURATE neo2TM Transfemoral Aortic Valve System according to the approved indication.
- •4.For subjects intended to use the SENTINELTM Cerebral Protection System in TAVR procedure, the diameters of subject’s left common carotid artery and brachiocephalic artery must be compatible with the SENTINELTM System.
排除标准
- •1.Subject has any of the contraindications listed in the IFU of study devices.
- •2.Subject had carotid stenting or carotid endarterectomy within the past 2 months.
- •3.Subject is currently enrolled in another investigational drug or device clinical trial that would directly interfere with this study.
- •4.Subject has known hypersensitivity or contraindications to contrast agent that, in the opinion of the investigator, cannot be adequately pre-medicated.
- •5.Subject has known hypersensitivity/allergy to the study device or protocol related therapies.
- •6.Subject has any medical condition that, in the opinion of the investigator, is not suitable to use the study devices.
- •7.Subject has a life expectancy of less than 12 months due to non-cardiac, comorbid conditions based on assessment of the investigator at the time of enrollment.
- •8.Subject is unable or not willing to complete follow-up visits and examinations including telephonic follow-ups for the duration of the study.
结局指标
主要结局
All cause mortality through 30 days post index procedure
时间窗: 30 Dyas Psot Index Procedure
Occurrence of major adverse events MAE, defined as a composite of all cause death, all stroke, transient ischemic attack TIA, major vascular complications, major and life-threatening bleeding events and acute kidney injury (stage 2 - 3) at 72 hours post procedure or hospital discharge (whichever comes first), per VARC-2 definitions and adjudicated by Clinical Event Committee (CEC) (for the SENTINEL subgroup)
时间窗: 30 Dyas Psot Index Procedure
次要结局
- Secondary endpoints based on the VARC 2 endpoints & definitions will be collected peri & post procedure at discharge or 7 days post procedure whichever comes first 30 days 6 months & 12 months post index procedure unless otherwise specified below(Safety endpoints adjudicated by an independent CEC)
研究者
Dr Ashok Seth
Fortis Escorts Heart Institute
研究点 (10)
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