Feasibility Study of the Supira System in Patients Undergoing High-Risk Percutaneous Coronary Intervention (HRPCI) Who May Benefit From Mechanical Circulatory Support Beyond the PCI Procedure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Safety
研究概览
简要总结
The objective of this study is to assess the safety and feasibility of the Supira System in heart failure patients with low LVEF, undergoing HRPCI with use of mechanical circulatory support who may benefit from cardiovascular hemodynamic support beyond the PCI procedure.
详细描述
The study is a prospective, non-randomized, single-arm, multi-center, feasibility study.
The Supira System is a minimally invasive, percutaneous ventricular assist device (pVAD) that is intended to provide hemodynamic support to patients undergoing high risk percutaneous coronary intervention (HRPCI) and requiring hemodynamic support. The Catheter is inserted percutaneously, across the aortic valve, and into the left ventricle under fluoroscopic guidance. The left ventricle is unloaded by pumping blood from the ventricle into the ascending aorta and systemic circulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has pre-existing heart failure, with NYHA Class II, III or IV prior to the index admission and documented LVEF ≤ 45%
- •Subject is presenting with one of the following criteria: unprotected left main coronary artery (ULMCA) disease, last patent vessel, or 3-vessel disease
- •Subject may benefit from hemodynamic support beyond the index procedure
- •Informed consent granted by the patient or legally authorized representative
排除标准
- •Stroke within 6 months of the index procedure, or any prior stroke with permanent neurologic deficit
- •Aortic valvular disease or regurgitation categorized as moderate or greater (≥2+ on a 4-grade scale as assessed on TTE)
- •Aortic stenosis and/or aortic regurgitation categorized as moderate or greater (mean gradient >20 mmHg or valve area <1.5 cm2 as assessed on TTE)
- •Presence of decompensated liver disease; severe liver dysfunction (Child-Pugh Score class C)
- •Ongoing renal replacement therapy with dialysis or continues renal replacement therapy
- •Heparin-induced thrombocytopenia, current or any prior occurrences
- •Known hypersensitivity to intravenous contrast agents that cannot be adequately pre-medicated or known hypersensitivity to heparin, aspirin, adenosine diphosphate (ADP) receptor inhibitors, or nitinol
- •Known or suspected coagulopathy or abnormal coagulation parameters (defined as platelet count ≤ 100,000/mm³ or spontaneous International Normalized Ratio (INR) ≥1.5 in the absence of medication or known fibrinogen ≤1.5 g/L)
- •Breastfeeding or pregnant
- •Currently participating in active follow-up phase of another clinical study of an investigational drug or device
- •Other medical, social, or psychological problems that, in the opinion of the Investigator, compromises the subject's ability to provide written informed consent and/or to comply with study procedures
研究组 & 干预措施
HRPCI with low LVEF and severe CAD
Patients undergoing HRPCI with low LVEF and severe coronary artery disease who may benefit from cardiovascular hemodynamic support beyond the PCI procedure
干预措施: Supira System (Device)
结局指标
主要结局
Safety
时间窗: Perioperative/Periprocedural
Rate of major device-related adverse events (MDRAEs), from device (Supira Introducer sheath) insertion through device removal (inclusive of Supira procedure-related serious adverse events \[SAEs\]).
Feasibility:
时间窗: Perioperative/Periprocedural
Successful hemodynamic support using the Supira System during high-risk percutaneous coronary intervention (HRPCI) and post-PCI as needed, with planned removal of the Supira Pump without the need to escalate/exchange to another MCS device such as Intra-aortic Balloon Pump (IABP) or Extracorporeal Membrane Oxygenation (ECMO).
次要结局
- Secondary Study Endpoints(30 days)