Prospective, Multi-center, Single-Arm Feasibility Study of the transShield Embolic Protection System
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Aortic Stenosis
- 发起方
- TransAortic Medical, Inc.
- 入组人数
- 28
- 试验地点
- 4
- 主要终点
- Safety - Incidence of 30-Day combined rate of the following events directly related to the transShield EPS as defined by VARC-2
- 状态
- 已完成
- 最后更新
- 2年前
概览
简要总结
The objective of this study is to evaluate the safety and performance of the transShield Embolic Protection System (EPS) used for embolic protection during Transcatheter Aortic Valve Replacement (TAVR).
详细描述
This is a prospective, multi-center, single arm feasibility study to assess the safety and performance of the transShield EPS. Patients with severe native aortic valve stenosis scheduled for TAVR will be screened for study eligibility. Subjects who meet the commercially approved indications for TAVR and comply with the study inclusion/exclusion criteria are eligible for enrollment. Patients will be followed for 30 days post procedure.
研究者
入排标准
入选标准
- •Patients must meet all of the following criteria to be eligible for participation in the study:
- •Patient is \>18 years old
- •Patient is scheduled for percutaneous TAVR with up to 20French compatible commercial TAVR system
- •Patient meets indications for TAVR per the device Instructions For Use
- •The diameter of the artery at the site of the filter placement is between 28 mm and 42 mm
- •Size and condition of the femoral artery iliac arteries are appropriate for the 12French transShield Expandable Introducer and 20F Embolic Protection Device
- •Patient, or authorized representative, signs a written Informed Consent form to participate in the study, prior to any study mandated procedures
- •Patient is willing and able to complete follow-up requirements
排除标准
- •Patients must be EXCLUDED from participation in this study if any of the following criteria are met:
- •Patient not undergoing TAVR via the trans-femoral route
- •Carotid artery stenosis \>70% in either carotid artery
- •Severe vascular tortuosity or anatomy that would preclude the safe introduction of the device
- •Aortic valve is a congenital unicuspid or congenital bicuspid valve or is non-calcified
- •Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation \>3+)
- •A known contraindication or hypersensitivity to all anticoagulation regimens or an inability to undergo anticoagulation for the study procedure
- •History of bleeding diathesis or in whom anticoagulant and/or anti-platelet therapy is contraindicated, patients who will refuse transfusion, or havean active peptic ulcer or upper GI bleeding within the prior 3 months
- •Renal insufficiency, defined as a creatinine level \> 221μmol/L and/or end-stage renal disease requiring chronic dialysis at time of treatment
- •History of stroke or transient ischemic attack (TIA) within prior 6 months
结局指标
主要结局
Safety - Incidence of 30-Day combined rate of the following events directly related to the transShield EPS as defined by VARC-2
时间窗: 30 day combined rate post-procedure
* Major Adverse Cardiac and Cerebrovascular Events (MACCE) * All cause mortality * All cause stroke (disabling and non-disabling) * Acute kidney injury (Stage 2 or 3) * Major vascular complications
Performance - Technical Success defined as the transShield EPS ability to perform all the following functions without adjudicated device malfunction
时间窗: During the procedure
* Ability to successfully deploy the device in the correct anatomical position, in the ascending aorta without interference with TAVR procedure/devices * Ability to retrieve and remove the device intact, including no visual evidence of any filter damage
次要结局
- Safety - Incidence of minor vascular complications directly related to the transShield EPS as defined by VARC-2.(30 days post-procedure)