Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2025-12-24 @ 10:59 PM
NCT ID:
NCT04849169
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
-The perforation location prevents complete inflation or proper placement of the Ringer catheter, as detailed in the Instructions for Use (IFU).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04849169
Study Brief:
Protocol Section:
NCT04849169