Investigation of the Ringer Perfusion Balloon Catheter

Completed · Not applicable

Conditions studied: Coronary Artery Perforation

In brief

The objective of this study is to demonstrate reasonable assurance that the Ringer catheter can be safely used to manage hemorrhage due to coronary vessel perforations while facilitating distal perfusion under the conditions of use prescribed in the labeling.

Key facts

Study ID

NCT04849169

Run by

Vascular Solutions LLC

People needed

30

Starts

2022-07-18

Expected to finish

2023-11-21

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…

• At least 18 years of age at the time of the PCI procedure
• Subject has fluoroscopically confirmed vessel perforation (classified as any type) requiring management of hemorrhage until a definitive treatment is determined
• Female subjects of childbearing potential must have a negative pregnancy test per standard of care for PCI

You may not qualify if…

• The perforation location prevents complete inflation or proper placement of the Ringer catheter, as detailed in the Instructions for Use (IFU).

Where it is running

• Piedmont Heart Institute — Atlanta, Georgia, United States
• Emory Heart & Vascular Center — Atlanta, Georgia, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham & Women's Hospital — Boston, Massachusetts, United States
• Henry Ford Health System — Detroit, Michigan, United States
• University of Washington Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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