A Prospective, Multicenter, Single-arm Investigation of the Ringer Perfusion Balloon Catheter (Ringer PTCA Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 14
- 主要终点
- Effectiveness of device success in dilatation/pre-dilatation of coronary stenosis during PCI.
研究概览
简要总结
The objective of this study is to demonstrate safe and effective use of the Ringer perfusion balloon catheter for dilatation/pre-dilatation of coronary stenoses during percutaneous coronary intervention (PCI).
详细描述
A prospective, multicenter, single-arm clinical study. The study will be conducted in 3 to 5 investigational sites in the US and Canada and will enroll up to 60 participants. The population for this study is adult participants undergoing non-emergent percutaneous coronary intervention (PCI) as a stand-alone procedure or following non-emergent diagnostic angiography performed during the same procedure.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and Female subjects >18 years old.
- •Patients undergoing clinically indicated non-emergent PCI as a stand-alone procedure or in combination with diagnostic angiography during the same procedure.
- •Study target lesion characteristics: a) native de-novo coronary stenosis of at least 70% visually estimated stenosis, or at least 50% visually estimated stenosis and shown to be physiologically significant by flow-mediated criteria (FFR <0.80, IFR <0.91); b) estimated reference vessel diameter 2.0-4.5mm; c) lesion length <25mm; d) calcification not greater than mild.
- •Per investigator assessment, the patient may benefit from inflation distal perfusion during balloon inflation. Examples include, but are not limited to: (i) LV systolic dysfunction with LVEF<50% by any modality; (ii) a territory subtended by the target vessel downstream from the target lesion that is estimated to be in excess of 25% of viable LV mass; (iii) prior hemodynamic or electrical instablility during intervention on the target lesion; (iv) the potential to avoid placement of a coronary stent if a stent-like result can be achieved through prolonged balloon inflation.
- •Female subjects of childbearing potential must have a negative pregnancy test per standard of care for PCI and be practicing contraception.
- •Informed consent provided.
排除标准
- •Hemodynamic or arrhythmic instability within 48 hours or a myocardial infarction within 72 hours of PCI.
- •More than 2 lesions planned during index PCI.
- •Procedural complication developing prior to PCI of study target.
- •Ejection fraction (EF) <25%.
- •Creatinine clearance (Cr-Cl) <25 mg/dL.
- •Baseline flow at study target <TIMI-2.
结局指标
主要结局
Effectiveness of device success in dilatation/pre-dilatation of coronary stenosis during PCI.
时间窗: During Procedure
Successful delivery, inflation, deflation and withdrawal of the Ringer device; final thrombolysis in myocardial infarction (TIMI) flow grade of 3 at the conclusion of the PCI procedure.
Rate of clinically relevant events
时间窗: Discharge or 30 days, whichever comes first
Rate of Ringer related complications arising during delivery, inflation or removal of Ringer; freedom from major cardiac adverse events (MACE)
次要结局
- TIMI Flow(During Procedure)
- Successful PCI(During Procedure)
- Ringer Inflation(During Procedure)