Investigation of the Ringer Perfusion Balloon Catheter (Ringer PTCA)

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.

Inclusion criteria

• 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.

Exclusion criteria

• 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.