Investigation of the Ringer Perfusion Balloon Catheter (Ringer PTCA)

Completed · Not applicable

Conditions studied: Coronary Stenosis

In brief

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).

Key facts

Study ID

NCT04862689

Run by

Vascular Solutions LLC

People needed

60

Starts

2022-05-01

Expected to finish

2023-06-30

Last updated by the study team

2023-12-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Torrance Memorial Medical Center — Torrance, California, United States
• Brigham & Women's Hospital — Boston, Massachusetts, United States
• St. Luke's Hospital — Kansas City, Missouri, United States
• University of Washington Medical Center — Seattle, Washington, United States
• Heart Health Institute — Scarborough Village, Ontario, Canada
• Sunnybrook Heath Sciences Center — Toronto, Ontario, Canada
• St. Michael's Hospital — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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