Investigation of the Ringer Perfusion Balloon Catheter (Ringer PTCA)

A Prospective, Multicenter, Single-arm Investigation of the Ringer Perfusion Balloon Catheter (Ringer PTCA Study)

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).

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.