NCT07276711招募中不适用
Controlled Arterial Protection to Ultimately Remove Embolic Material
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- EmStop Inc
- 入组人数
- 663
- 试验地点
- 3
- 主要终点
- Non-Inferiority
研究概览
简要总结
The objective of this study is to demonstrate safety and efficacy of the EmStop Embolic Protection System when used as indicated to capture and remove thrombus/debris during self-expanding transcatheter aortic valve replacement (TAVR) procedures.
详细描述
This is a prospective, single-blind, multi-center, randomized study conducted in up to 25 U.S. investigational sites. Subjects with severe aortic valve stenosis (AS) will be randomized 2:1 to the EmStop Embolic Protection System (study device) versus the Sentinel device (control group) and followed to 30 days post TAVR procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Subjects will be blinded to their treatment assignment to minimize expectation and reporting bias. Procedural teams will be unblinded due to the nature of device deployment; the device is temporary and not intended for implantation. Every effort will be made to have follow-up personnel remain blinded, with those conducting the neurological assessments being most critical.
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical Inclusion Criteria
- •Age ≥ 22 years at the time of consent
- •Meets FDA-approved indications for elective transfemoral self-expanding transcatheter aortic valve replacement (TAVR) procedure on a native or non-native (valve-in-valve) aortic valve. Note: Due to Neurologist availability and importance of capturing the neurological assessments, procedures must be performed Monday-Thursday.
- •Left ventricular ejection fraction ≥ 30% as confirmed by echocardiogram
- •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
- •Imaging Inclusion Criteria
- •Echocardiogram including left ventricular ejection fraction ≥ 30% within 6 months (180 days) prior to the index procedure and prior to randomization to confirm adequate cardiac function.
- •Subjects must undergo a computed tomography angiography (CTA) scan within 6 months (180 days) prior to the index procedure and prior to randomization to confirm anatomic compatibility with the study device and the control device. Subjects must meet the following anatomical inclusion criteria:
- •EmStop Angiographic (CTA) Inclusion Criteria
- •Subject anatomy is compatible with correct device positioning with:
- •Ascending aorta length ≥8 cm
- •Femoral and iliac artery minimal lumen diameter of ≥ 8.0 mm
- •Ascending aorta/aortic arch diameter is ≥25 or ≤40 mm.
- •Ascending aorta or aortic arch exhibits ≤ Grade 1 atheromatous disease and limited wall calcification
- •Sentinel Angiographic (CTA) Inclusion Criteria
- •1. Subject anatomy, excluding bovine arch anatomy, is compatible with correct device positioning with:
- •Artery diameter is 9-15 mm for the brachiocephalic artery and 6.5-10 mm in the left common carotid artery
- •Arterial stenosis <70% in either the left common carotid artery or the brachiocephalic artery
- •Brachiocephalic or left carotid artery without significant stenosis, ectasia, dissection, or aneurysm at the aortic ostium or within 3 cm of the aortic ostium
- •Adequate blood flow to the right upper extremity
- •Access vessels without excessive tortuosity
排除标准
- •Requires use of a balloon-expandable transcatheter aortic valve for the index procedure
- •Documented history of stroke or transient ischemic attack (TIA) within the prior 6 months, or any prior stroke with a permanent major disability or deficit (National Institute of Health Stroke Scale [NIHSS] >1 at baseline)
- •Left ventricular ejection fraction <30%, cardiogenic shock, or hypotension requiring inotropes or mechanical circulatory support, within 3 months prior to index procedure
- •Acute myocardial infarction (MI) within 30 days of the planned index procedure
- •Planned to undergo any other open cardiac surgical or left heart interventional procedure (e.g., concurrent coronary revascularization) during the TAVR procedure or within 30 days prior to the TAVR procedure. The need for a postoperative pacemaker implant after TAVR is not exclusionary.
- •Renal failure, defined as estimated glomerular filtration rate (eGFR) <30 mL/min
- •Hypercoagulable state that cannot be corrected by additional periprocedural heparin
- •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
- •Undergoing therapeutic thrombolysis
- •History of bleeding diathesis or major coagulopathy
- •Hepatic failure (Child-Pugh class C)
- •Active endocarditis or ongoing systemic infection, defined as fever (>38°C) and/or WBC >15,000 IU
- •Known allergy to any materials used in the EmStop system (e.g., nitinol)
- •Currently participating in another drug or device clinical study
- •Known or suspected to be pregnant, or is lactating; women of child bearing age must have a negative serum or urine pregnancy test within 48 hours prior to the index study procedure
- •Vulnerable subject populations (e.g., incarcerated or cognitively challenged adults)
- •Any other clinical reasons deemed by the investigators of the study in which the patient would not be an appropriate candidate for the study
研究组 & 干预措施
EmStop System
Experimental
干预措施: EmStop Embolic Protection System (Device)
Boston Scientific Sentinel device
Active Comparator
干预措施: Boston Scientific Sentinel (Device)
结局指标
主要结局
Non-Inferiority
时间窗: Non-inferiority of 30-day EmStop device MACCE patient incidence rate compared to the Sentinel device patient incidence rate
Primary combined safety and efficacy endpoint is the rate of major adverse cardiac and cerebrovascular events (MACCE) at 30-days
次要结局
- Debris Capture(30 days)
- Non-Inferiority(30 days)
研究者
研究点 (3)
Loading locations...
相似试验
进行中（未招募）
不适用
PROTECT - Prophylaxis of ThromboEmbolism in Critical Care Trial - PROTECTCritically ill patients who require admission to the intensive care unit and need pharmacologic thromboprophylaxisEUCTR2009-012387-13-GBMcMaster University3,650
已完成
不适用
Simple and safe exclusion of pulmonary embolism using quantitative d-dimer and Wells simplified decision rulePulmonary embolism, clinically suspectedCirculatory SystemPulmonary heart diseaseISRCTN10533382eiden University Medical Centre (LUMC) (The Netherlands)879
招募中
不适用
Prevention of local thromboembolic complications during continuous infusion of coagulation factor concentrates: parallel infusion of saline or heparin?Continuous infusionCoagulation factor concentratesHeparinSalineNL-OMON23399MC utrecht42
已完成
不适用
Prevention of local thromboembolic complications during continuous infusion of coagulation factor concentrates: parallel infusion of saline versus heparin and parallel infusion of saline?bleeding disorderHaemophilia10005330NL-OMON36776niversitair Medisch Centrum Utrecht42
已完成
不适用
Prevention of Thromboembolic Events – European Registry in Venous ThromboembolismMedDRA - Venous ThromboembolismI82Other venous embolism and thrombosisDRKS00004795Daiichi-Sankyo Europe GmbH3,544