VITALYST EFS: VITALYST Temporary Percutaneous Transvalvular Circulatory Support System Early Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 10
- 主要终点
- Clinical Success
研究概览
简要总结
The VITALYST Early Feasibility study (EFS) is designed to evaluate the feasibility and safety of the VITALYST System in subjects undergoing elective high-risk percutaneous coronary intervention (HR-PCI).
详细描述
The VITALYST EFS is a prospective, open-label, single-arm, multicenter feasibility study of the VITALYST System.
The VITALYST System will be used to provide temporary circulatory support in patients undergoing non-emergent high risk percutaneous interventions (HR-PCI).
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
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject provides signed informed consent.
- •Subject is ≥ 18 years and < 90 years of age.
- •Subject is indicated for NON-emergent PCI of at least one de novo or restenotic lesion in a native coronary vessel or coronary artery bypass graft (CABG) and has left ventricular ejection fraction (LVEF) ≤ 50% with the following: Unprotected left main or Last remaining vessel or Three vessel disease (at least one ≥ 50% diameter stenosis based on center's visual assessment in all three major epicardial territories)
- •Heart team, which must include a cardiac surgeon, agrees that HR-PCI is appropriate.
排除标准
- •Subject has had STEMI within 72 hours with persistent elevation of cardiac enzymes.
- •Subject has had pre-procedure cardiac arrest requiring CPR within 24 hours of enrollment.
- •Subject has systolic blood pressure < 90 mmHg with evidence of end organ hypoperfusion (e.g., cool extremities or urine < 30 mL/hour).
- •Subject has had need for inotropes/vasopressors or mechanical circulatory support (including intra-aortic balloon pump) in the previous 24 hours to maintain a systolic blood pressure ≥ 90 mmHg.
- •Subject has left ventricular mural thrombus.
- •Subject has a prosthetic aortic valve.
- •Subject has pericarditis or constrictive heart disease (constrictive pericarditis or restrictive cardiomyopathy).
- •Subject has moderate or greater aortic valve stenosis or moderate or greater aortic valve insufficiency (by echocardiographic assessment, graded as > 2+).
- •Subject has abnormalities of the aorta that preclude safe delivery of the device, including severe calcification, tortuosity, aneurysm, or prior surgery.
- •Subject has PVD preventing passage of the device (e.g., calcification, small caliber) or tortuosity that would preclude safe placement of the introducer sheath as per the IFU.
- •Subject is not on dialysis and has creatinine > 4 mg/dL.
- •Subject has a history of liver dysfunction (Childs Class C) with elevation of liver enzymes and bilirubin > 3× ULN or INR ≥
- •Subject has had a recent (within 30 days) stroke or TIA.
- •Subject has known hypersensitivity to intravenous contrast agents that cannot be adequately pre-medicated or has known hypersensitivity to heparin, aspirin, ADP receptor inhibitors or nitinol.
- •Subject has current or a history of heparin induced thrombocytopenia.
- •Subject has uncorrected abnormal coagulation or platelet count ≤ 75,000/mm³ or INR ≥ 2.
- •Subject has significant right heart failure based on any one of the following criteria: RVSWI < 0.30 mmHg·L/m² or PVR > 3.6 Woods units or Pulmonary artery pulsatility index < 1.85
- •Subject requires non-elective mechanical ventilation.
- •Subject has an atrial or ventricular septal defect (including post-infarct VSD).
- •Subject has left ventricular rupture.
- •Subject has cardiac tamponade.
- •Subject has severe pulmonary disease (FEV1 < 1L).
- •Subject has sustained or non-sustained ventricular tachycardia.
- •Subject is breast feeding or is pregnant.
- •Subject has infection of the proposed procedural access site or active systemic infection.
- •Subject has any condition that requires premature discontinuation of recommended antiplatelet and/or anticoagulant therapy before 90 days following the index procedure.
- •Any use of a mechanical circulatory support device within 14 days prior to the index procedure.
- •Staged PCI is planned within 90 days following device removal.
- •Subject is participating in another investigational drug or device study that has not reached its primary endpoint.
- •Subject has other disease condition(s) resulting in the subject being unsuitable for participation in the clinical trial (e.g., advanced malignancy with limited expected survival)
- •Subject has other disease condition(s) which the Investigator has determined may cause non-compliance to the study requirements.
结局指标
主要结局
Clinical Success
时间窗: Measured through 72 hours or hospital discharge (whichever comes first) after the intervention/procedure
The primary endpoint consists of the composite endpoint of Clinical Success \[measured through 72 hours or hospital discharge (whichever comes first)\], which is defined as follows. * Technical Success: Successful delivery of the device to the correct anatomical position; and Successful operation and removal of the VITALYST circulatory support system * Absence of termination of revascularization procedure due to hemodynamic concern, or escalation to ECMO or other more intensive mechanical circulatory support device, or the use of vasopressors or inotropes * No conversion to open heart surgery * No mortality
次要结局
未报告次要终点