Controlled Arterial Protection to Ultimately Remove Embolic Material
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- EmStop Inc
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Number of Participants With Procedural Success
研究概览
简要总结
The objective of this study is to demonstrate device feasibility, safety and investigate performance of the EmStop Embolic Protection System when used as indicated in 15 subjects at 2 investigational sites in the U.S.
详细描述
The investigation is a prospective, multi-center, single arm feasibility study. Subjects will undergo treatment with a currently marketed TAVR device and the EmStop Embolic Protection System and will then be followed to 30 days post-procedure. This is a treatment-only feasibility investigation intended to capture and characterize outcomes, especially safety outcomes, with the EmStop System.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical & Angiographic Inclusion Criteria
- •Between 21 and 90 years of age at the time of consent
- •Meets FDA approved indications for transcatheter aortic valve replacement (TAVR) procedure on a native aortic valve using a commercially available Abbott or Medtronic transcatheter heart valve
- •Willing and able to provide written informed consent and written HIPAA authorization prior to initiation of study procedures
- •Willing and able to comply with the protocol-specified procedures and assessments
- •Subject anatomy is compatible with correct device deployment and positioning with:
- •Ability to achieve access with a 21 French equivalent femoral access sheath
- •Ascending aorta length ≥8 cm
- •Ascending aorta/aortic arch diameter is ≥25 or ≤40 mm
- •Ascending aorta or aortic arch exhibits ≤ Grade 1 atheromatous disease and limited wall calcification
排除标准
- •Requires urgent or emergent TAVR procedure
- •Contraindicated to MRI
- •Previously implanted aortic or mitral valve bioprosthesis
- •Hepatic failure (Child-Pugh class C)
- •Hypercoagulable state that cannot be corrected by additional periprocedural heparin
- •Planned to undergo any other cardiac surgical or interventional procedure (e.g., concurrent coronary revascularization) during the TAVR procedure or within 30 days prior to the TAVR procedure. NOTE: Diagnostic cardiac catheterization is permitted up until baseline MRI is obtained. Once baseline MRI is obtained, no additional intra-aortic or intracardiac procedure may occur.
- •Acute myocardial infarction within 30 days of the planned index procedure
- •Renal failure, defined as estimated glomerular filtration rate (eGFR) <30 mL/min
- •Documented history of stroke or TIA within the prior 6 months, or any prior stroke with a permanent major disability or deficit (NIHSS >1 at baseline)
- •Left ventricular ejection fraction ≤30% within 3 months prior to procedure
- •History of intolerance, allergic reaction, or contraindication to any of the study medications, including heparin, aspirin, clopidogrel, or a sensitivity to contrast media or anesthesia that cannot be adequately pre-treated
- •Known allergy or sensitivity to nickel-titanium
- •Active endocarditis or ongoing systemic infection, defined as fever (>38°C) and/or white blood cell (WBC) >15,000 IU
- •Undergoing therapeutic thrombolysis
- •History of bleeding diathesis or a coagulopathy
- •Known or suspected to be pregnant, or is lactating; female subjects of child-bearing potential must have a negative serum or urine pregnancy test within 48 hours prior to the index study procedure.
- •Currently participating in another drug or device clinical study
- •Any other clinical reason, as deemed by the investigators of the study, by which the patient would not be an appropriate candidate for the study
- •Vulnerable subject populations (e.g., incarcerated or cognitively challenged adults)
研究组 & 干预措施
EmStop Embolic Protection System
Transcatheter aortic valve replacement (TAVR) procedures with the EmStop Embolic Protection System (EmStop System).
干预措施: The EmStop Embolic Protection System (EmStop System) (Device)
结局指标
主要结局
Number of Participants With Procedural Success
时间窗: During the procedure
Defined as successful insertion, deployment, positioning, and removal of the EmStop System in the absence of device interference
Occurrence of Major Adverse Cardiac and Cerebrovascular Events (MACCE) at 30 Days
时间窗: 30 days follow-up
Defined as composite of the VARC-2 defined components (all-cause mortality, all stroke (disabling and non-disabling), acute kidney injury stage 2 or 3 (including renal replacement therapy) within 72 hours)
次要结局
- Average Number of Captured Embolic Debris(During the procedure)
- Average Number of Captured Particles ≥140 μm in Diameter(Procedural)
- Total Acute Infarct Burden(14 days pre-procedure to 18-36 hours post-procedure)
- Occurrence of Transient Ischemic Attack (TIA)(30 days)