Status:
COMPLETED
Investigation of the Ringer Perfusion Balloon Catheter
Lead Sponsor:
Vascular Solutions LLC
Conditions:
Coronary Artery Perforation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 perfus...
Detailed Description
A prospective, multicenter, single-arm clinical study. The study will be conducted at up to 15 investigational sites in the US and will enroll up to 30 participants. The population for this investigat...
Eligibility Criteria
Inclusion
- 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
Exclusion
- The perforation location prevents complete inflation or proper placement of the Ringer catheter, as detailed in the Instructions for Use (IFU).
Key Trial Info
Start Date :
July 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 21 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04849169
Start Date
July 18 2022
End Date
November 21 2023
Last Update
December 22 2023
Active Locations (6)
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1
Piedmont Heart Institute
Atlanta, Georgia, United States, 30309
2
Emory Heart & Vascular Center
Atlanta, Georgia, United States, 30322
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
4
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115